Moderate to Severe Ulcerative ColitisPhase 2NCT03627052
A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
A Phase 2 study testing Itacitinib in people with Moderate to Severe Ulcerative Colitis, run by Incyte Corporation.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Moderate to Severe Ulcerative Colitis
- What is being tested?
- Itacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2018to 13 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence.
- Have a 3-component Mayo score of 4 to 9, which includes a modified Mayo Endoscopy Score (mMES) of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥ 1.
- Must have failed or be intolerant to (discontinued the medication due to an adverse event as determined by the investigator) at least 1 of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine, biologic therapy (eg, infliximab, vedolizumab or adalimumab).
- Participants currently receiving the following treatment(s) for UC are eligible, provided they have been receiving acceptable and stable dose(s): oral 5-ASA or oral corticosteroids.
- No evidence of active or latent or inadequately treated tuberculosis infection.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Clinical signs of fulminant colitis or toxic megacolon.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease.
- Disease limited to the distal 15 cm of the colon.
- Receiving (or expected to receive) the following therapies within protocol-designated timeframes before the baseline visit or during the study: Natalizumab; anti-TNF therapy; Vedolizumab or any investigational anti-adhesion molecule therapy; Ustekinumab or any on or off label biologic therapy; interferon therapy; cyclosporine, mycophenolate, or tacrolimus; daily dose of oral corticosteroids ≥ 25 mg prednisone or equivalent; intravenous corticosteroids; rectally administered formulation of corticosteroids or 5-aminosalicylic acid; and AZA, 6-MP, or methotrexate.
- Enema treatments within 2 weeks of the baseline visit, with the exception of enema bowel preparations for clinical assessments.
- Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin at the screening visit.
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- Other immunocompromised states and history of opportunistic infections.
- History of stomach or intestinal surgery, including bariatric surgery (Note: appendectomy and/or cholecystectomy, is allowed).
- o surgery for UC or likely to require surgery for UC during the study.
- If at risk for colorectal cancer, must have had a colonoscopy within protocol-defined timeframes.
- History of recurrent, disseminated, or multiple dermatomal herpes zoster.
- History of alcohol or drug abuse.
- History of active malignancy within 5 years of screening, excluding superficial basal and squamous cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix.
- Current or recent history (within 30 days before randomization) of a clinically meaningful viral, bacterial, fungal, parasitic, or mycobacterial infection.
- Previously received either lymphocyte apheresis or selective monocyte granulocyte apheresis (eg, Cellsorba) within 1 year of baseline.
- History of unstable ischemic heart disease or uncontrolled hypertension.
- Positive serology test results for HIV, for hepatitis B surface antigen or core antibody, or for HCV antibody with detectable RNA at screening.
- Participants taking potent systemic CYP3A4 inhibitors or inducers or fluconazole within 2 weeks or 5 half-lives (whichever is longer) of baseline.
- Participants taking P-gp substrates with narrow therapeutic index, including digoxin within 2 weeks or 5 half-lives (whichever is longer) of baseline.
About this study
Official title: A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).
- Conditions
- Moderate to Severe Ulcerative Colitis
- Being tested
- Itacitinib, Placebo
- Keywords
- Inflammatory bowel disease, ulcerative colitis, Janus kinase inhibitor, JAK1
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
In the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. In the open-label extension, itacitinib administered at doses determined from the double-blind period.
PlaceboDrug
Placebo administered orally twice daily in the double-blind period.
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib | Experimental | Not described Receives: Drug: Itacitinib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a Clinical Response
To evaluate the efficacy of itacitinib inducing a Clinical Response.
Measured: Week 8
Secondary outcomes (11)
Proportion of participants with Endoscopic Response
To evaluate the efficacy of itacitinib on endoscopic outcomes.
Measured: Week 8
Proportion of participants with Mucosal Healing
To evaluate the efficacy of itacitinib on endoscopic outcomes.
Measured: Week 8
Proportion of participants in Endoscopic Remission
To evaluate the efficacy of itacitinib on endoscopic outcomes.
Measured: Week 8
Proportion of participants in Clinical Remission
To evaluate the efficacy of itacitinib on clinical outcomes.
Measured: Week 8
Change from baseline in 3-component Mayo score
To evaluate the efficacy of itacitinib on clinical outcomes.
Measured: Week 8
Change from baseline in Physician's Global Assessment score
To evaluate the efficacy of itacitinib on clinical outcomes.
Measured: Week 8
Change in Quality of Life score as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
To evaluate the efficacy of itacitinib on quality of life outcomes.
Measured: Week 8
Cmax of itacitinib
Maximum observed plasma concentrations.
Measured: Week 4
Ctau of itacitinib
Plasma concentrations
Measured: Weeks 2 and 4
Stool concentration of itacitinib -~30-hr collection
Measured: Week 4
Number of treatment-emergent adverse events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to approximately 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start20 Sep 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Why it stopped: Study withdrawn due to lack of recruitment. No patients enrolled. No safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Brown, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627052
- Sponsor's protocol ID
- INCB 39110-210
- Status last verified
- Dec 2019
- First submitted
- 8 Aug 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03627052
- Acronym / sponsor ID
- INCB 39110-210
- Conditions
- Moderate to Severe Ulcerative Colitis
- Keywords
- Inflammatory bowel disease, ulcerative colitis, Janus kinase inhibitor, JAK1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to lack of recruitment. No patients enrolled. No safety concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itacitinib | Experimental | Drug: Itacitinib |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence.
- Have a 3-component Mayo score of 4 to 9, which includes a modified Mayo Endoscopy Score (mMES) of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥ 1.
- Must have failed or be intolerant to (discontinued the medication due to an adverse event as determined by the investigator) at least 1 of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine, biologic therapy (eg, infliximab, vedolizumab or adalimumab).
- Participants currently receiving the following treatment(s) for UC are eligible, provided they have been receiving acceptable and stable dose(s): oral 5-ASA or oral corticosteroids.
- No evidence of active or latent or inadequately treated tuberculosis infection.
Key exclusion criteria (19 listed)
- Clinical signs of fulminant colitis or toxic megacolon.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease.
- Disease limited to the distal 15 cm of the colon.
- Receiving (or expected to receive) the following therapies within protocol-designated timeframes before the baseline visit or during the study: Natalizumab; anti-TNF therapy; Vedolizumab or any investigational anti-adhesion molecule therapy; Ustekinumab or any on or off label biologic therapy; interferon therapy; cyclosporine, mycophenolate, or tacrolimus; daily dose of oral corticosteroids ≥ 25 mg prednisone or equivalent; intravenous corticosteroids; rectally administered formulation of corticosteroids or 5-aminosalicylic acid; and AZA, 6-MP, or methotrexate.
- Enema treatments within 2 weeks of the baseline visit, with the exception of enema bowel preparations for clinical assessments.
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 |
|---|---|---|
| ItacitinibAlso: INCB039110In the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. In the open-label extension, itacitinib administered at doses determined from the double-blind period. | Drug | Itacitinib |
| PlaceboPlacebo administered orally twice daily in the double-blind period. | Drug | Placebo |
Primary outcome
Proportion of participants with a Clinical Response
Time frame: Week 8
To evaluate the efficacy of itacitinib inducing a Clinical Response.
11 secondary outcomes
Proportion of participants with Endoscopic Response
Time frame: Week 8
Proportion of participants with Mucosal Healing
Time frame: Week 8
Proportion of participants in Endoscopic Remission
Time frame: Week 8
Proportion of participants in Clinical Remission
Time frame: Week 8
Change from baseline in 3-component Mayo score
Time frame: Week 8
Change from baseline in Physician's Global Assessment score
Time frame: Week 8
Change in Quality of Life score as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Week 8
Cmax of itacitinib
Time frame: Week 4
Ctau of itacitinib
Time frame: Weeks 2 and 4
Stool concentration of itacitinib -~30-hr collection
Time frame: Week 4
Number of treatment-emergent adverse events
Time frame: Up to approximately 60 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Kurt Brown, MD study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itacitinib in people with Moderate to Severe Ulcerative Colitis, run by Incyte Corporation.
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 6 inclusion and 19 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: withdrawn, as of the sponsor's last update on 6 Dec 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants with a Clinical Response (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2019.