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โ† Trials
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Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

RecruitingPhase 2Ages 18 Years - 75 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC). This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: CD specific: * Crohn's Disease Activity Index (CDAI) score of โ‰ฅ 220 * Confirmed diagnosis of CD at least 90 days prior to Baseline * Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of โ‰ฅ 6 for ileocolonic or colonic disease or SES-CD of โ‰ฅ 4 for isolated ileal disease. * Demonstrated failure of 1 or more therapy for CD UC specific: * Confirmed diagnosis of UC at least 90 days prior to Baseline * Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3 * Demonstrated failure of 1 or more therapy for UC Exclusion Criteria: * Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab) * Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment * Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame * Participants with surgical bowel resection within the past 3 months prior to Baseline CD specific: * Participants with \>3 prior bowel resections * Participants with previous small bowel resection(s) of combined length \>100 cm UC specific: * Participants with prior colectomy (total or subtotal) * Participants with extent of disease limited to \< 10 cm of rectum
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What it tests

  • Risankizumab
  • Trosunilimab
  • ABBV-701
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Where

65 sites
Digestive Health Specialists /ID# 280827
Dothan, United States
Elite Clinical Studies /ID# 280477
Phoenix, United States
Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
Sun City, United States
Clinnova Research /ID# 280509
Anaheim, United States
Southern California Res. Ctr /ID# 280476
Coronado, United States
Gastro Care Institute /ID# 281071
Lancaster, United States
United Medical Doctors - Los Alamitos /ID# 281125
Los Alamitos, United States
Inland Empire Liver Foundation - Rialto /ID# 280775
Rialto, United States

โ€ฆand 57 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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