Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
Digestive Health Specialists of the Southeast /ID# 239599
Dothan, Alabama, United States
East View Medical Research, LLC /ID# 240030
Mobile, Alabama, United States
Southern California Res. Ctr. /ID# 233512
Coronado, California, United States
Hoag Memorial Hosp Presbyterian /ID# 233555
Irvine, California, United States
University of Colorado Hospital /ID# 239361
Aurora, Colorado, United States
Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 (worst) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Time frame: Baseline to Week 12
Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI \< 150.
Time frame: Induction Period Week 12
Percentage of Participants Achieving Clinical Remission Per Average Daily Liquid or Very Soft Stool Frequency (SF) and Average Daily Abdominal Pain (AP) Score (SF/AP)
Clinical remission is defined as average daily liquid or very soft stool SF \<= 2.8 and not worse than Baseline and average daily AP score \<= 1 and not worse than Baseline.
Time frame: Induction Period Week 12
Percentage of Participants Achieving Endoscopic Response Per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time frame: Week 40 in the Maintenance Period
Percentage of Participants Achieving Clinical Remission Per CDAI
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI \< 150.
Time frame: Week 40 in the Maintenance Period
Percentage of Participants Achieving Clinical Remission Per SF/AP
Clinical remission is defined as average daily liquid or very soft SF \<= 2.8 and not worse than Baseline and average daily AP score \<= 1 and not worse than Baseline.
Time frame: Week 40 in the Maintenance Period
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Medical Research Center of CT /ID# 233542
Hamden, Connecticut, United States
Atlantic Medical Research /ID# 233506
Margate, Florida, United States
University of Miami /ID# 233811
Miami, Florida, United States
Gastroenterology Group Naples /ID# 233829
Naples, Florida, United States
Digestive Disease Consultants - Orange Park /ID# 241015
Orange Park, Florida, United States
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