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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570006
• Other study ID #: M21-446
• Secondary ID: 2022-501263-41-0
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 52-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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• ABBV-668
Oral Capsule

Locations

Country	Name	City	State
Belgium	UZ Gent /ID# 248605	Gent	Oost-Vlaanderen
Belgium	Universitair Ziekenhuis Leuven /ID# 248598	Leuven	Vlaams-Brabant
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 248928	Liege
Belgium	Vitaz /Id# 248607	Sint-Niklaas	Oost-Vlaanderen
France	CHU Grenoble - Hopital Michallon /ID# 252108	La Tronche
France	CHU Montpellier - Hôpital Saint Eloi /ID# 251876	Montpellier Cedex 5	Herault
France	Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357	Neuilly Sur Seine	Ile-de-France
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875	St-Priest-en-Jarez
Poland	Endoskopia Sp. z o.o. /ID# 255667	Sopot	Pomorskie
Poland	Gastromed Sp. z o.o /ID# 255664	Torun	Kujawsko-pomorskie
Poland	H-T Centrum Medyczne Endoterapia /ID# 255666	Tychy	Slaskie
Poland	Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663	Warsaw	Mazowieckie
United States	Atrium Health /ID# 249273	Charlotte	North Carolina
United States	Gastro SB /ID# 249271	Chula Vista	California
United States	Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208	Garland	Texas
United States	Gastroenterology Associates, P.A. of Greenville /ID# 249217	Greenville	South Carolina
United States	Baylor College of Medicine /ID# 249203	Houston	Texas
United States	NYU Langone Long Island Clinical Research Associates /ID# 250075	Lake Success	New York
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 249278	Macon	Georgia
United States	Ctr for Advanced Gastroenterol /ID# 249226	Maitland	Florida
United States	Atlantic Medical Research /ID# 249213	Margate	Florida
United States	Quality Medical Research /ID# 251125	Nashville	Tennessee
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	Endoscopic Research, Inc. /ID# 249202	Orlando	Florida
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	Southern Star Research Institute, LLC /ID# 249212	San Antonio	Texas
United States	Options Health Research, LLC /ID# 249216	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  France,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Endoscopic Improvement	Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. The Endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration).	Week 8
Primary	Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 56 weeks
Secondary	Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score	Clinical Remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) = 1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore (ESS) = 1.The adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore, Rectal Bleeding subscore and Endoscopy subscore.	Week 8
Secondary	Percentage of Participants Achieving Clinical Response per Adapted Mayo Score	Clinical response per Adapted Mayo Score is defined as decrease from baseline = 2 points and = 30%, plus a decrease in RBS = 1 or an absolute RBS = 1. The adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore, Rectal Bleeding subscore and Endoscopy subscore.	Week 8
Secondary	Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score	Clinical response per Partial Adapted Mayo Score is defined as decrease from baseline = 1 points and = 30%, plus a decrease in RBS = 1 or an absolute RBS = 1. The Partial Adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore and Rectal Bleeding subscore.	Week 8
Secondary	Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) = 0. The Endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration).	Week 8

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