NCT05570006CompletedPhase 2
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 Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 5 Oct 2022
- Start date
- 16 Mar 2023
- Primary completion date
- 23 Dec 2024
- Lead sponsor
- AbbVie
- Diseases
- Ulcerative colitis
- NCT number
- NCT05570006
- EU CT number
- 2022-501263-41-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 16 Mar 2023 to the primary completion date, 23 Dec 2024
- 30 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| CHC Coordinator of this site? Confirm its status | Liege | Belgium | Completed |
| Verenigde Ziekenhuizen van Waas en Durme Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Hopital Saint Eloi Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Centre Medico Chirurgical Ambroise Pare Hartmann Coordinator of this site? Confirm its status | Neuilly-Sur-Seine | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Endoskopia Sp z o.o. Coordinator of this site? Confirm its status | Sopot | Poland | Completed |
| GASTROMED Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| H-T.Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Tychy | Poland | Completed |
| WIP Warsaw IBD Point Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| Atrium Health /ID# 249273 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Gastro SB /ID# 249271 Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208 Coordinator of this site? Confirm its status | Garland | United States | Unknown status |
| Gastroenterology Associates, P.A. of Greenville /ID# 249217 Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Baylor College of Medicine /ID# 249203 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| NYU Langone Long Island Clinical Research Associates /ID# 250075 Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Gastroenterology Associates of Central Georgia, LLC /ID# 249278 Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Ctr for Advanced Gastroenterol /ID# 249226 Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Atlantic Medical Research /ID# 249213 Coordinator of this site? Confirm its status | Margate | United States | Unknown status |
| Quality Medical Research /ID# 251125 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Lenox Hill Hospital /ID# 250008 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center /ID# 250189 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Endoscopic Research, Inc. /ID# 249202 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| University of Pennsylvania /ID# 250012 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh MC /ID# 250071 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Southern Star Research Institute, LLC /ID# 249212 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Options Health Research, LLC /ID# 249216 Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.