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

NCT05570006 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: M21-4462022-501263-41-00
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 30

Brief 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. 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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; ABBV-668

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline, Week 8

• Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score

  Baseline, Week 8

• Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score

  Baseline, Week 8

• Percentage of Participants Achieving Endoscopic Remission

  Week 8

Study Arms (1)

ABBV-668

EXPERIMENTAL

Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks.

Drug: ABBV-668

Interventions

ABBV-668 DRUG

Oral Capsule

ABBV-668

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (30)

Gastro SB /ID# 249271

Chula Vista, California, 91910-5619, United States

Location

Ctr for Advanced Gastroenterol /ID# 249226

Maitland, Florida, 32751-6108, United States

Location

Atlantic Medical Research /ID# 249213

Margate, Florida, 33063-5737, United States

Location

Endoscopic Research, Inc. /ID# 249202

Orlando, Florida, 32803, United States

Location

Gastroenterology Associates of Central Georgia, LLC /ID# 249278

Macon, Georgia, 31201, United States

Location

NYU Langone Long Island Clinical Research Associates /ID# 250075

Lake Success, New York, 11042, United States

Location

Columbia University Medical Center /ID# 250189

New York, New York, 10032-3729, United States

Location

Lenox Hill Hospital /ID# 250008

New York, New York, 10075, United States

Location

Atrium Health /ID# 249273

Charlotte, North Carolina, 28204-2963, United States

Location

Options Health Research, LLC /ID# 249216

Tulsa, Oklahoma, 74104, United States

Location

University of Pennsylvania /ID# 250012

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh MC /ID# 250071

Pittsburgh, Pennsylvania, 15260, United States

Location

Gastroenterology Associates, P.A. of Greenville /ID# 249217

Greenville, South Carolina, 29607, United States

Location

Quality Medical Research /ID# 251125

Nashville, Tennessee, 37211, United States

Location

Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208

Garland, Texas, 75044, United States

Location

Baylor College of Medicine /ID# 249203

Houston, Texas, 77030, United States

Location

Southern Star Research Institute, LLC /ID# 249212

San Antonio, Texas, 78229-5390, United States

Location

UZ Gent /ID# 248605

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Vitaz /Id# 248607

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 248598

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Groupe Sante CHC - Clinique du MontLegia /ID# 248928

Liège, 4000, Belgium

Location

CHU Montpellier - Hopital Saint Eloi /ID# 251876

Montpellier, Herault, 34295, France

Location

CHU Grenoble - Hopital Michallon /ID# 252108

La Tronche, Isere, 38700, France

Location

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875

St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Gastromed Sp. z o.o /ID# 255664

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Endoskopia Sp. z o.o. /ID# 255667

Sopot, Pomeranian Voivodeship, 81-756, Poland

Location

H-T Centrum Medyczne Endoterapia /ID# 255666

Tychy, Silesian Voivodeship, 43-100, Poland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 6, 2022
• Study Start: March 16, 2023
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (18); PL (4); BE (4); FR (4)