A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD
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.
Inclusion Criteria:
Exclusion Criteria:
- Participants with prior intolerance to adalimumab.
Ann Arbor, Michigan 48109, United States
Wyoming, Michigan 49519, United States
Englewood, New Jersey 07631-4152, United States
Pittsburgh, Pennsylvania 15224, United States
Greenville, South Carolina 29607, United States
Edmonton, Alberta T5R 1W2, Canada
North York, Ontario M6A 3B4, Canada
Saint Priest EN Jarez, Pays de la Loire Region 42270, France
Kiel, Schleswig-Holstein 24105, Germany
Pireaus, 18454, Greece
Nagakute-shi, Aichi-ken 480-1195, Japan
Kashiwa-shi, Chiba 277-0871, Japan
Asahikawa-shi, Hokkaido 070-8610, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Kyoto, Kyoto 602-8566, Japan
Suita-shi, Osaka 565-0871, Japan
Sunto-gun, Shizuoka 411-8611, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Mitaka-shi, Tokyo 181-8611, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjuku-ku, Tokyo 162-8655, Japan
Shinjuku-ku, Tokyo 162-8666, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Otago, Otago 9016, New Zealand
Warsaw, Masovian Voivodeship 02-507, Poland
Guimarães, Braga District 4835-044, Portugal
Banská Bystrica, 975 17, Slovakia
Ferrol, A Coruna 15405, Spain
Exeter, Devon EX2 5DW, United Kingdom
Southampton, Hampshire SO16 6YD, United Kingdom