Ulcerative ColitisPhase 2NCT05570006
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
A Phase 2 study testing ABBV-668 in people with Ulcerative Colitis, run by AbbVie at 30 sites in 4 countries.
Trial summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ABBV-668
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 16 Mar 2023to 23 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
- Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or targeted immunomodulators (including biologics and non-biologics)
Who cannot join
- Current diagnosis of crohn's disease (CD) or inflammatory bowel disease-unclassified (IBD-U).
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States18 sites
Atrium Health /ID# 249273
Charlotte, North Carolina, 28204-2963
Gastro SB /ID# 249271
Chula Vista, California, 91910-5619
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208
Garland, Texas, 75044
Gastroenterology Associates, P.A. of Greenville /ID# 249217
Greenville, South Carolina, 29607
Baylor College of Medicine /ID# 249203
Houston, Texas, 77030
NYU Langone Long Island Clinical Research Associates /ID# 250075
Lake Success, New York, 11042
Gastroenterology Associates of Central Georgia, LLC /ID# 249278
Macon, Georgia, 31201
Ctr for Advanced Gastroenterol /ID# 249226
Maitland, Florida, 32751-6108
Atlantic Medical Research /ID# 249213
Margate, Florida, 33063-5737
Quality Medical Research /ID# 251125
Nashville, Tennessee, 37211
Columbia University Medical Center /ID# 250189
New York, New York, 10032-3729
Lenox Hill Hospital /ID# 250008
New York, New York, 10075
Endoscopic Research, Inc. /ID# 249202
Orlando, Florida, 32803
University of Pennsylvania /ID# 250012
Philadelphia, Pennsylvania, 19104-5502
Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh MC /ID# 250071
Pittsburgh, Pennsylvania, 15260
Southern Star Research Institute, LLC /ID# 249212
San Antonio, Texas, 78229-5390
Options Health Research, LLC /ID# 249216
Tulsa, Oklahoma, 74104
Belgium4 sites
UZ Gent /ID# 248605
Ghent, Oost-Vlaanderen, 9000
Universitair Ziekenhuis Leuven /ID# 248598
Leuven, Vlaams-Brabant, 3000
Groupe Sante CHC - Clinique du MontLegia /ID# 248928
Liège, 4000
Vitaz /Id# 248607
Sint-Niklaas, Oost-Vlaanderen, 9100
France4 sites
CHU Grenoble - Hopital Michallon /ID# 252108
La Tronche, Isere, 38700
CHU Montpellier - Hopital Saint Eloi /ID# 251876
Montpellier, Herault, 34295
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357
Neuilly-sur-Seine, Île-de-France Region, 92200
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875
St-Priest-en-Jarez, Pays de la Loire Region, 42270
Poland4 sites
Endoskopia Sp. z o.o. /ID# 255667
Sopot, Pomeranian Voivodeship, 81-756
Gastromed Sp. z o.o /ID# 255664
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
H-T Centrum Medyczne Endoterapia /ID# 255666
Tychy, Silesian Voivodeship, 43-100
Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663
Warsaw, Masovian Voivodeship, 00-728
About this study
Official title: A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed.
ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 30 sites globally.
Read more
Participants will receive oral capsules of ABBV-668 twice daily for 16 weeks and will undergo a 30 day follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
- Conditions
- Ulcerative Colitis
- Being tested
- ABBV-668
- Keywords
- Ulcerative Colitis, ABBV-668
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-668Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| ABBV-668 | Experimental | Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks. Receives: Drug: ABBV-668 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.
Measured: Week 8
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks)
Secondary outcomes (4)
Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
- Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
- Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
- Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
Clinical remission per Adapted Mayo Score was defined as SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1. Data are reported for the percentage of participants achieving clinical remission per adapted Mayo score.
Measured: Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.
Clinical response per Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per adapted Mayo score.
Measured: Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores:
Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
The overall Partial Adapted Mayo score ranges from 0 to 6 where higher scores represent more severe disease.
Clinical response per Partial Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per partial adapted Mayo score.
Measured: Baseline, Week 8
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission was defined as Mayo endoscopic subscore of 0. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start16 Mar 2023
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
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.
- Other trials for Ulcerative ColitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570006
- Sponsor's protocol ID
- M21-446
- Other IDs
- 2022-501263-41-00
- Status last verified
- Dec 2025
- First submitted
- 5 Oct 2022
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05570006
- Acronym / sponsor ID
- M21-446
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, ABBV-668
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed.
ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 30 sites globally.
Participants will receive oral capsules of ABBV-668 twice daily for 16 weeks and will undergo a 30 day follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-668 | Experimental | Drug: ABBV-668Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
- Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or targeted immunomodulators (including biologics and non-biologics)
Key exclusion criteria (2 listed)
- Current diagnosis of crohn's disease (CD) or inflammatory bowel disease-unclassified (IBD-U).
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
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 |
|---|---|---|
| ABBV-668Oral Capsule | Drug | ABBV-668 |
Primary outcome
Percentage of Participants Achieving Endoscopic Improvement
Time frame: Week 8
Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.
Number of Participants With Adverse Events (AEs)
Time frame: From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
4 secondary outcomes
Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
Time frame: Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
Time frame: Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
Time frame: Baseline, Week 8
Percentage of Participants Achieving Endoscopic Remission
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABBV-668 in people with Ulcerative Colitis, run by AbbVie at 30 sites in 4 countries.
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 2 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Belgium, France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 23 Dec 2025). 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 Achieving Endoscopic Improvement (time frame: Week 8). 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?
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 23 Dec 2025.