Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis

Completed · Phase 2

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT05570006

Run by

AbbVie

People needed

30

Starts

2023-03-16

Expected to finish

2024-12-23

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Gastro SB /ID# 249271 — Chula Vista, California, United States
• Ctr for Advanced Gastroenterol /ID# 249226 — Maitland, Florida, United States
• Atlantic Medical Research /ID# 249213 — Margate, Florida, United States
• Endoscopic Research, Inc. /ID# 249202 — Orlando, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC /ID# 249278 — Macon, Georgia, United States
• NYU Langone Long Island Clinical Research Associates /ID# 250075 — Lake Success, New York, United States
• Columbia University Medical Center /ID# 250189 — New York, New York, United States
• Lenox Hill Hospital /ID# 250008 — New York, New York, United States
• Atrium Health /ID# 249273 — Charlotte, North Carolina, United States
• Options Health Research, LLC /ID# 249216 — Tulsa, Oklahoma, United States
• University of Pennsylvania /ID# 250012 — Philadelphia, Pennsylvania, United States
• Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079 — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh MC /ID# 250071 — Pittsburgh, Pennsylvania, United States
• Gastroenterology Associates, P.A. of Greenville /ID# 249217 — Greenville, South Carolina, United States
• Quality Medical Research /ID# 251125 — Nashville, Tennessee, United States
• Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208 — Garland, Texas, United States
• Baylor College of Medicine /ID# 249203 — Houston, Texas, United States
• Southern Star Research Institute, LLC /ID# 249212 — San Antonio, Texas, United States
• UZ Gent /ID# 248605 — Ghent, Oost-Vlaanderen, Belgium
• Vitaz /Id# 248607 — Sint-Niklaas, Oost-Vlaanderen, Belgium
• Universitair Ziekenhuis Leuven /ID# 248598 — Leuven, Vlaams-Brabant, Belgium
• Groupe Sante CHC - Clinique du MontLegia /ID# 248928 — Liège, Belgium
• CHU Montpellier - Hopital Saint Eloi /ID# 251876 — Montpellier, Herault, France
• CHU Grenoble - Hopital Michallon /ID# 252108 — La Tronche, Isere, France
• Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875 — St-Priest-en-Jarez, Pays de la Loire Region, France

Full record on ClinicalTrials.gov

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