Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT05570006
- Lead Sponsor
- AbbVie
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABBV-668 ABBV-668 Participants will receive ABBV-668 twice daily approximately at same time each day for 52 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Endoscopic Improvement Week 8 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).
Number of Participants with Adverse Events (AEs) Up to approximately 56 weeks 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score Week 8 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.
Percentage of Participants Achieving Endoscopic Remission Week 8 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).
Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score Week 8 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.
Percentage of Participants Achieving Clinical Response per Adapted Mayo Score Week 8 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.
Trial Locations
- Locations (30)
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
🇧🇪Gent, 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
🇧🇪Liege, Belgium
CHU Montpellier - Hopital Saint Eloi /ID# 251876
🇫🇷Montpellier Cedex 5, Herault, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357
🇫🇷Neuilly Sur Seine, Ile-de-France, 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, Loire, France
Gastromed Sp. z o.o /ID# 255664
🇵🇱Torun, Kujawsko-pomorskie, Poland
Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663
🇵🇱Warsaw, Mazowieckie, Poland
Endoskopia Sp. z o.o. /ID# 255667
🇵🇱Sopot, Pomorskie, Poland
H-T Centrum Medyczne Endoterapia /ID# 255666
🇵🇱Tychy, Slaskie, Poland