A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

What this study is about

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Who can join (things the study team will check)

✅ You may be able to join if…

• Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
• Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2
• Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
• Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy [ADT]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder [IR]) as defined in the protocol

🚫 You may not be able to join if…

• Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
• Presence of a stoma or ostomy
• Participants with presence of active fistulas may be included if there is no surgery needed
• Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
• Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

Where this trial is running

• AZ Gastro Care, Chandler, Arizona, United States
• Research Solutions of Arizona, Litchfield Park, Arizona, United States
• Mayo Clinic, Scottsdale, Arizona, United States
• Clinnova Research, Anaheim, California, United States
• Alliance Research Institute, LLC - Canoga Park, Canoga Park, California, United States
• Southern California Research Center, Coronado, California, United States
• Om Research, LLC 1, Lancaster, California, United States
• TLC Clinical Research Inc, Los Angeles, California, United States
• GastroIntestinal Bioscience, Los Angeles, California, United States
• Hoag Memorial Hospital, Newport Beach, California, United States
• Om Research, LLC 2, Oxnard, California, United States
• Clinical Applications Laboratories, Inc, San Diego, California, United States

+ 355 more sites.

Who to contact

Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07196722.