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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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).

Key facts

Study ID

NCT07196722

Run by

Janssen Research & Development, LLC

People needed

1092

Starts

2025-10-03

Expected to finish

2032-10-06

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Kansas Gastroenterology, LLC — Wichita, Kansas, United States (enrolling)
• AZ Gastro Care — Chandler, Arizona, United States (enrolling)
• Research Solutions of Arizona — Litchfield Park, Arizona, United States (enrolling)
• Alliance Research Institute, LLC - Canoga Park — Canoga Park, California, United States (enrolling)
• Mayo Clinic — Scottsdale, Arizona, United States (enrolling)
• Om Research, LLC 1 — Lancaster, California, United States (enrolling)
• Clinnova Research — Anaheim, California, United States (enrolling)
• GastroIntestinal Bioscience — Los Angeles, California, United States (enrolling)
• Hoag Memorial Hospital — Newport Beach, California, United States (enrolling)
• Om Research, LLC 2 — Oxnard, California, United States (enrolling)
• Southern California Research Center — Coronado, California, United States (enrolling)
• Medical Associates Research Group, Inc. — San Diego, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• TLC Clinical Research Inc — Los Angeles, California, United States (enrolling)
• American Institute of Research — Cutler Bay, Florida, United States (enrolling)
• Nature Coast Clinical Research — Inverness, Florida, United States (enrolling)
• Green Leaf Clinical Trials — Jacksonville, Florida, United States (enrolling)
• Florida Research Center Inc. — Lakewood Rch, Florida, United States (enrolling)
• Sanchez Clinical Research, Inc — Miami, Florida, United States (enrolling)
• GCP Clinical Research — Tampa, Florida, United States (enrolling)
• Children's Center for Digestive Health Care — Atlanta, Georgia, United States (enrolling)
• Gastroenterolgy Associates of Central GA — Macon, Georgia, United States (enrolling)
• IU Health University Hospital — Indianapolis, Indiana, United States (enrolling)
• Tri-State Gastroenterology Assoc — Crestview Hills, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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