EICHORCondition: Crohn's Disease · Ulcerative Colitis · Sponsor: AbbVie
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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 adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment with…
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: CD specific: * Crohn's Disease Activity Index (CDAI) score of ≥ 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 ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Auzmer Research /ID# 280786 | Lakeland, Florida, United States | — |
| Gastro Health - Miami /ID# 282001 | Miami, Florida, United States | — |
| Portland Gastroenterology Center - Portland - Congress Street /ID# 281970 | Portland, Maine, United States | — |
| Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865 | Hackensack, New Jersey, United States | — |
| Queens Village Primary Medical Center /ID# 281857 | New York, New York, United States | — |
| Digestive Disease Consultants - Brunswick /ID# 283935 | Brunswick, Ohio, United States | — |
| Skyline Gastroenterology of West Tennessee /ID# 284146 | Jackson, Tennessee, United States | — |
| Texas Digestive Disease Consultants /ID# 284159 | Austin, Texas, United States | — |
| Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947 | San Marcos, Texas, United States | — |
| Macquarie Hospital /ID# 281739 | Macquarie University, New South Wales, Australia | — |
| John Hunter Hospital /ID# 282537 | Newcastle, New South Wales, Australia | — |
| Mater Hospital Brisbane /ID# 281738 | South Brisbane, Queensland, Australia | — |
+ 18 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT07697456