Icotrokinra for moderately to severely active Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2/3 study tests icotrokinra versus placebo in participants with moderately to severely active Crohn's disease and will measure clinical efficacy and safety. Eligible participants must have a confirmed Crohn's diagnosis with both endoscopic and histopathologic evidence and meet specified CDAI and SES-CD thresholds at baseline. Central review of screening ileocolonoscopy videos is used to confirm endoscopic activity, and women of childbearing potential must have negative pregnancy tests before dosing. The trial includes administration of icotrokinra or matching placebo with follow-up visits to monitor symptoms, endoscopic findings, and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion criteria:

* 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's running

• AZ Gastro Care
  Chandler, Arizona, United States Recruiting
• Research Solutions of Arizona
  Litchfield Park, Arizona, United States Recruiting
• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• Clinnova Research
  Anaheim, California, United States Recruiting
• Southern California Research Center
  Coronado, California, United States Recruiting
• Om Research, LLC 1
  Lancaster, California, United States Recruiting

+345 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.