A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

A Phase 2 study testing ABT-494 in people with Crohn's Disease, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Crohn's Disease
What is being tested?: ABT-494
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 220 participants
Where: No sites listed yet
Study dates: 17 Mar 2015to 3 Aug 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Crohn's disease (CD) for at least 90 days.
Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
Subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Who cannot join

Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
Subject who has had surgical bowel resections in the past 6 months or is planning resection.
Subjects with an ostomy or ileoanal pouch.
Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
Subject who has short bowel syndrome.
Subject with recurring infections or active Tuberculosis (TB).

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

Conditions: Crohn's Disease
Being tested: Placebo, ABT-494
Keywords: Crohn's Disease
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Oral Dosing
ABT-494Drug
Also called Upadacitinib
Oral Dosing

Study groups in NCT02365649
Study group	Role	What they receive
Induction Period ABT-494 Twice Daily Medium/High Dose	Active comparator	Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day Receives: Drug: ABT-494
Extension Phase ABT-494 High Dose	Active comparator	Extension Phase ABT-494 High Dose orally dosed twice a day Receives: Drug: ABT-494
Induction Period Placebo	Placebo comparator	Induction Period Placebo orally dosed twice a day Receives: Drug: Placebo
Induction Period ABT-494 Low Dose	Active comparator	Induction Period ABT-494 Low Dose orally dosed twice a day Receives: Drug: ABT-494
Induction Period ABT-494 Once Daily Medium/High Dose	Active comparator	Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day Receives: Drug: ABT-494
Extension Phase ABT-494 Low Dose	Active comparator	Extension Phase ABT-494 Low Dose orally dosed twice a day Receives: Drug: ABT-494
Induction Period ABT-494 High Dose	Active comparator	Induction Period ABT-494 High Dose orally dosed twice a day Receives: Drug: ABT-494
Induction Period ABT-494 Low/Medium Dose	Active comparator	Induction Period ABT-494 Low/Medium Dose orally dosed twice a day Receives: Drug: ABT-494
Extension Phase ABT-494 Medium Dose	Active comparator	Extension Phase ABT-494 Medium Dose orally dosed twice a day Receives: Drug: ABT-494

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable.
Measured: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Who Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 16

Secondary outcomes (54)

Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Measured: Week 16
Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
Measured: Week 16
Percentage of Participants Who Achieve Clinical Remission at Week 12
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 12
Percentage of Participants Who Achieve Remission at Week 16
Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Week 16
Percentage of Participants Who Achieve Response at Week 16
Response is defined as endoscopic response at Week 12/16 AND clinical response at Week 16. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Week 16
Percentage of Participants With Endoscopic Response at Week 12/16
Endoscopic response: SES-CD at least 25% reduction from Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Who Achieve Clinical Response at Week 16
Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 16
Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 16
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Measured: Week 16
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16
Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 16
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16
Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
Measured: Baseline, Week 4, Week 16
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16
Measured: Baseline, Week 16
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life.
Measured: Baseline, Week 8, Week 16
Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16
Remission is defined as endoscopic remission AND clinical remission. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Week 16
Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission and a score above 450 indicates very severe disease.
Measured: Week 16
Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16
Endoscopic remission: SES-CD ≤ 4 and at least two point reduction versus Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 16
Change From Baseline in Abdominal Pain Rating Scale at Week 12
Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
Measured: Baseline, Week 12
Change From Baseline in Abdominal Pain Rating Scale at Week 16
Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
Measured: Baseline, Week 16
Percentage of Participants Who Achieve Remission at Week 52
Remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. See definitions of responder and clinical responder in Outcome Measure 7 of this record.
Measured: Week 52
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Week 52
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Endoscopic remission was defined as SES-CD <= 4 and at least 2 points reduction versus induction baseline and no subscore > 1 in any individual variable. Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than induction baseline AND average daily abdominal pain <= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Measured: Week 52
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Induction Baseline and average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Response at Week 52
Response at Week 52 was defined as both endoscopic response at Week 52 and clinical response at Week 52. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline.
The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Week 52
Percentage of Participants With SES-CD ≤ 2 at Week 52
SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Measured: Week 52
Percentage of Participants With SES-CD = 0 at Week 52
SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Measured: Week 52
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Endoscopic response was defined as SES-CD at least 25% reduction from Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Measured: Week 52
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Enhanced endoscopic response was defined as SES-CD reduction from Induction Baseline > 50% (or for an Induction Baseline SES-CD of 4, at least a 2 point reduction from Induction Baseline). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Measured: Week 52
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Endoscopic Improvement: SES-CD reduction from Induction Baseline > 50% or endoscopic remission. Endoscopic remission was defined as SES-CD <= 4 and at least 2 points reduction versus Induction Baseline and no subscore > 1 in any individual variable. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Measured: Week 52
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Endoscopic healing was defined as SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore >= 1 at Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Measured: Week 52
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical response was defined as average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline or average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline AND average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Steroid-free remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2 point reduction versus Induction Baseline and no subscore > 1 in any individual variable. Clinical remission: Average daily stool frequency ≤ 1.5 and not worse than baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Measured: Baseline, Week 52
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Steroid-free clinical remission was defined as average daily stool frequency <= 1.5 and not worse than Induction Baseline AND average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Steroid-free modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than Induction Baseline AND average daily abdominal pain <= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Steroid-free endoscopic remission was defined as SES-CD <= 4 and at least 2 points reduction versus Induction Baseline and no subscore > 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Baseline, Week 52
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
Measured: Week 20, Week 28, Week 36, Week 44, Week 52
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Measured: Baseline, Week 28, Week 52
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Measured: Baseline, Week 20, Week 28, Week 36, Week 44, Week 52
Change From Induction Baseline in IBDQ at Week 52
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function, and social function. Each subscale can be computed with total scores ranging from 10 to 70, 5 to 35, 12 to 84, and 5 to 35, respectively.
Measured: Baseline, Week 52
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. A positive change represents an improvement in health-related quality of life.
Measured: Baseline, Week 52
Change From Induction Baseline in EQ-5D VAS at Week 52
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in health-related quality of life.
Measured: Baseline, Week 52
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
Presented as percentage of participants with given number of EIMs at Baseline (BL) and Week (Wk) 52. EIMs of Crohn's disease included anemia, autoimmune hepatitis, axial arthropathy, bronchiectasis, chronic obstructive pulmonary disease, episcleritis, erythema nodosum, iritis, nephrolithiasis, oral aphthous ulcers, peripheral arthropathy, primary sclerosing cholangitis, pyoderma gangrenosum, Sweet's syndrome, uveitis, and venous thromboembolism.
Measured: Baseline, Week 52
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Remission at Week 52 is defined as endoscopic remission at Week 52 AND clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Measured: Baseline, Week 52
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Modified clinical remission was defined as average daily stool frequency <= 2.8 and not worse than induction baseline AND average daily abdominal pain <= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 20153 Aug 2017

First posted19 Feb 2015 (estimated)
Study start17 Mar 2015
Primary completion25 Nov 2016
Study completion3 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02365649
Sponsor's protocol ID: M13-740
Other IDs: 2014-003240-12, 2014
Status last verified: Dec 2023
First submitted: 16 Feb 2015
Last updated: 27 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.
PubMed 34546360
Aguilar D, Revilla L, Garrido-Trigo A, Panes J, Lozano JJ, Planell N, Esteller M, Lacerda AP, Guay H, Butler J, Davis JW, Salas A. Randomized Controlled Trial Substudy of Cell-specific Mechanisms of Janus Kinase 1 Inhibition With Upadacitinib in the Crohn's Disease Intestinal Mucosa: Analysis From the CELEST Study. Inflamm Bowel Dis. 2021 Nov 15;27(12):1999-2009. doi: 10.1093/ibd/izab116.
PubMed 34042156
Peyrin-Biroulet L, Louis E, Loftus EV Jr, Lacerda A, Zhou Q, Sanchez Gonzalez Y, Ghosh S. Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease. Adv Ther. 2021 May;38(5):2339-2352. doi: 10.1007/s12325-021-01660-7. Epub 2021 Mar 23.
PubMed 33755884
Sandborn WJ, Feagan BG, Loftus EV Jr, Peyrin-Biroulet L, Van Assche G, D'Haens G, Schreiber S, Colombel JF, Lewis JD, Ghosh S, Armuzzi A, Scherl E, Herfarth H, Vitale L, Mohamed MF, Othman AA, Zhou Q, Huang B, Thakkar RB, Pangan AL, Lacerda AP, Panes J. Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn's Disease. Gastroenterology. 2020 Jun;158(8):2123-2138.e8. doi: 10.1053/j.gastro.2020.01.047. Epub 2020 Feb 8.
PubMed 32044319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingPhase 2
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Fibrostenotic Crohn's Disease
Enrolling by invitationPhase 4
INSIGHT-IBD Pragmatic Study
Ulcerative Colitis (UC), Crohn Disease (CD)
RecruitingPhase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis, Crohn's Disease

All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Upadacitinib (ABT-494) for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
ClinicalTrials.gov ID: NCT02365649
Acronym / sponsor ID: M13-740
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 17 Mar 2015 (actual)
Primary completion: 25 Nov 2016 (actual)
Study completion: 3 Aug 2017 (actual)
First posted: 19 Feb 2015 (estimated)
Results: Posted 14 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
Induction Period ABT-494 Twice Daily Medium/High Dose	Active comparator	Drug: ABT-494Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day
Extension Phase ABT-494 High Dose	Active comparator	Drug: ABT-494Extension Phase ABT-494 High Dose orally dosed twice a day
Induction Period Placebo	Placebo comparator	Drug: PlaceboInduction Period Placebo orally dosed twice a day
Induction Period ABT-494 Low Dose	Active comparator	Drug: ABT-494Induction Period ABT-494 Low Dose orally dosed twice a day
Induction Period ABT-494 Once Daily Medium/High Dose	Active comparator	Drug: ABT-494Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day
Extension Phase ABT-494 Low Dose	Active comparator	Drug: ABT-494Extension Phase ABT-494 Low Dose orally dosed twice a day
Induction Period ABT-494 High Dose	Active comparator	Drug: ABT-494Induction Period ABT-494 High Dose orally dosed twice a day
Induction Period ABT-494 Low/Medium Dose	Active comparator	Drug: ABT-494Induction Period ABT-494 Low/Medium Dose orally dosed twice a day
Extension Phase ABT-494 Medium Dose	Active comparator	Drug: ABT-494Extension Phase ABT-494 Medium Dose orally dosed twice a day

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of Crohn's disease (CD) for at least 90 days.
Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
Subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Key exclusion criteria (6 listed)

Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
Subject who has had surgical bowel resections in the past 6 months or is planning resection.
Subjects with an ostomy or ileoanal pouch.
Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
Subject who has short bowel syndrome.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboOral Dosing	Drug	Induction Period Placebo
ABT-494Also: UpadacitinibOral Dosing	Drug	Extension Phase ABT-494 High Dose, Extension Phase ABT-494 Low Dose, Extension Phase ABT-494 Medium Dose, Induction Period ABT-494 High Dose, Induction Period ABT-494 Low Dose, Induction Period ABT-494 Low/Medium Dose, Induction Period ABT-494 Once Daily Medium/High Dose, Induction Period ABT-494 Twice Daily Medium/High Dose

Primary outcome

Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore > 1 in any individual variable.
Percentage of Participants Who Achieve Clinical Remission at Week 16
Time frame: Week 16
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).

54 secondary outcomes

Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
Time frame: Week 16
Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16
Time frame: Week 16
Percentage of Participants Who Achieve Clinical Remission at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve Remission at Week 16
Time frame: Week 16
Percentage of Participants Who Achieve Response at Week 16
Time frame: Week 16
Percentage of Participants With Endoscopic Response at Week 12/16
Time frame: Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Who Achieve Clinical Response at Week 16
Time frame: Week 16
Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16
Time frame: Week 16
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16
Time frame: Week 16
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16
Time frame: Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16
Time frame: Week 16
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16
Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
Time frame: Baseline, Week 4, Week 16
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
Time frame: Baseline, Week 8, Week 16
Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16
Time frame: Week 16
Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16
Time frame: Week 16
Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16
Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline
Time frame: Week 16
Change From Baseline in Abdominal Pain Rating Scale at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Abdominal Pain Rating Scale at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Who Achieve Remission at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Time frame: Week 52
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Response at Week 52
Time frame: Week 52
Percentage of Participants With SES-CD ≤ 2 at Week 52
Time frame: Week 52
Percentage of Participants With SES-CD = 0 at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Time frame: Week 52
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Time frame: Week 20, Week 28, Week 36, Week 44, Week 52

Results and safety

Results posted to the registry on 14 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Double-Blind Induction Phase: Placebo BID	37	27
Double-Blind Induction Phase: Upadacitinib 3 mg BID	39	34
Double-Blind Induction Phase: Upadacitinib 6 mg BID	37	33
Double Blind Induction Phase: Upadacitinib 12 mg BID	36	27
Double Blind Induction Phase: Upadacitinib 24 mg BID	36	29
Double Blind Induction Phase: Upadacitinib 24 mg QD	35	30
Double Blind Extension Phase: Upadacitinib 3 mg BID	0	0
Double Blind Extension Phase: Upadacitinib 6 mg BID	0	0
Double Blind Extension Phase: Upadacitinib 12 mg BID	0	0
Double Blind Extension Phase: Upadacitinib 24 mg QD	0	0

Primary outcome: Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16

Time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.). Number. Unit: percentage of participants

Measure	Double-Blind Induction Phase: Placebo BID n = 37	Double-Blind Induction Phase: Upadacitinib 3 mg BID n = 39	Double-Blind Induction Phase: Upadacitinib 6 mg BID n = 37	Double Blind Induction Phase: Upadacitinib 12 mg BID n = 36	Double Blind Induction Phase: Upadacitinib 24 mg BID n = 36	Double Blind Induction Phase: Upadacitinib 24 mg QD n = 35
Value	0	10.3	8.1	8.3	22.2	14.3

Double-Blind Induction Phase: Placebo BID vs Double-Blind Induction Phase: Upadacitinib 3 mg BID: Adjusted risk difference from placebo: 9.9 (95% CI -0.3 to 20.1), p = 0.056, Cochran-Mantel-Haenszel
Double-Blind Induction Phase: Placebo BID vs Double-Blind Induction Phase: Upadacitinib 6 mg BID: Adjusted risk difference from placebo: 7.4 (95% CI -1.6 to 16.4), p = 0.108, Cochran-Mantel-Haenszel
Double-Blind Induction Phase: Placebo BID vs Double Blind Induction Phase: Upadacitinib 12 mg BID: Adjusted risk difference from placebo: 7.7 (95% CI -1.5 to 16.8), p = 0.099, Cochran-Mantel-Haenszel

Population analysed: Modified intention to Treat (mITT) Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.

Primary outcome: Percentage of Participants Who Achieve Clinical Remission at Week 16

Time frame: Week 16. Number. Unit: percentage of participants

Measure	Double-Blind Induction Phase: Placebo BID n = 37	Double-Blind Induction Phase: Upadacitinib 3 mg BID n = 39	Double-Blind Induction Phase: Upadacitinib 6 mg BID n = 37	Double Blind Induction Phase: Upadacitinib 12 mg BID n = 36	Double Blind Induction Phase: Upadacitinib 24 mg BID n = 36	Double Blind Induction Phase: Upadacitinib 24 mg QD n = 35
Value	10.8	12.8	27.0	11.1	22.2	14.3

Double-Blind Induction Phase: Placebo BID vs Double-Blind Induction Phase: Upadacitinib 3 mg BID: Adjusted risk difference from placebo: 2.5 (95% CI -12.3 to 17.3), p = 0.74, Cochran-Mantel-Haenszel
Double-Blind Induction Phase: Placebo BID vs Double-Blind Induction Phase: Upadacitinib 6 mg BID: Adjusted risk difference from placebo: 16.2 (95% CI -2.0 to 34.3), p = 0.082, Cochran-Mantel-Haenszel
Double-Blind Induction Phase: Placebo BID vs Double Blind Induction Phase: Upadacitinib 12 mg BID: Adjusted risk difference from placebo: 0.5 (95% CI -14.1 to 15.0), p = 0.952, Cochran-Mantel-Haenszel

Population analysed: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.

54 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-Blind Induction Phase: Placebo BID	2 of 37 (5.4%)	25 of 37 (67.6%)	0 of 37
Double-Blind Induction Phase: Upadacitinib 3 mg BID	5 of 39 (12.8%)	32 of 39 (82.1%)	0 of 39
Double-Blind Induction Phase: Upadacitinib 6 mg BID	2 of 37 (5.4%)	27 of 37 (73%)	0 of 37
Double Blind Induction Phase: 12 mg BID	10 of 36 (27.8%)	23 of 36 (63.9%)	0 of 36
Double Blind Induction Phase: 24 mg BID	3 of 36 (8.3%)	28 of 36 (77.8%)	0 of 36
Double Blind Induction Phase: 24 mg QD	7 of 35 (20%)	25 of 35 (71.4%)	0 of 35
Double Blind Extension Phase: 3 mg BID	18 of 60 (30%)	31 of 60 (51.7%)	0 of 60
Double Blind Extension Phase: 6 mg BID	2 of 23 (8.7%)	9 of 23 (39.1%)	0 of 23
Double Blind Extension 12 mg BID	5 of 59 (8.5%)	35 of 59 (59.3%)	0 of 59
Double Blind Extension 24 mg QD	5 of 36 (13.9%)	14 of 36 (38.9%)	0 of 36
Open Label Extension Subjects Never Received OL 24 mg BID	11 of 33 (33.3%)	8 of 33 (24.2%)	0 of 33
Open Label Extension Subjects Received OL 24 mg BID	4 of 27 (14.8%)	17 of 27 (63%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34546360Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.
Derived from this study: PubMed 34042156Aguilar D, Revilla L, Garrido-Trigo A, Panes J, Lozano JJ, Planell N, Esteller M, Lacerda AP, Guay H, Butler J, Davis JW, Salas A. Randomized Controlled Trial Substudy of Cell-specific Mechanisms of Janus Kinase 1 Inhibition With Upadacitinib in the Crohn's Disease Intestinal Mucosa: Analysis From the CELEST Study. Inflamm Bowel Dis. 2021 Nov 15;27(12):1999-2009. doi: 10.1093/ibd/izab116.
Derived from this study: PubMed 33755884Peyrin-Biroulet L, Louis E, Loftus EV Jr, Lacerda A, Zhou Q, Sanchez Gonzalez Y, Ghosh S. Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease. Adv Ther. 2021 May;38(5):2339-2352. doi: 10.1007/s12325-021-01660-7. Epub 2021 Mar 23.
Derived from this study: PubMed 32044319Sandborn WJ, Feagan BG, Loftus EV Jr, Peyrin-Biroulet L, Van Assche G, D'Haens G, Schreiber S, Colombel JF, Lewis JD, Ghosh S, Armuzzi A, Scherl E, Herfarth H, Vitale L, Mohamed MF, Othman AA, Zhou Q, Huang B, Thakkar RB, Pangan AL, Lacerda AP, Panes J. Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn's Disease. Gastroenterology. 2020 Jun;158(8):2123-2138.e8. doi: 10.1053/j.gastro.2020.01.047. Epub 2020 Feb 8.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-494 in people with Crohn's Disease, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16 (time frame: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02365649, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.