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Icotrokinra for moderately to severely active Crohn's disease

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Phase2; Phase3 Interventional Janssen Research & Development, LLC · NCT07196722

This trial will test whether icotrokinra helps people with moderately to severely active Crohn's disease reduce intestinal inflammation and symptoms compared with a placebo.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment1092 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations358 sites (Chandler, Arizona and 357 other locations)
Trial IDNCT07196722 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of Crohn's disease who meet the study's moderate-to-severe activity criteria (specified CDAI and SES-CD thresholds and evidence of ulceration) are the intended participants.

Not a fit: People with mild or inactive Crohn's disease or those who do not meet the CDAI/SES-CD entry criteria are unlikely to benefit from participating in this trial.

Why it matters

Potential benefit: If effective, icotrokinra could reduce intestinal inflammation and symptoms and provide a new treatment option for patients with moderate-to-severe Crohn's disease.

How similar studies have performed: Other therapies targeting inflammatory pathways have shown benefit in Crohn's disease, but icotrokinra itself is being tested in Phase 2/3 and its efficacy has not yet been established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 357 other locations

+308 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.