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

Study on Investigational Medication for Crohn's Disease

M
Monika Fischer, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase 2/3
2 participants needed
1 Location

Brief description of study

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).

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

The clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active CD will be conducted under a single protocol consisting of 3 separate studies:

  • A 12-week Phase 2b Induction Dose-ranging Study (Induction Study 1)
  • A 12-week Phase 3 Induction Study (Induction Study 2)
  • A 40-week Phase 3 Maintenance Study 

All 3 studies will be randomized, double-blind, placebo-controlled, parallel group, and multicenter evaluating the safety and efficacy of icotrokinra in participants with moderately to severely active CD
(defined as CD activity index [CDAI] ≥220 and ≤450 and simple endoscopic score for CD [SES-CD] ≥6, or ≥4 for participants with isolated ileal disease) who have demonstrated an inadequate response, loss of response, or were intolerant to previous conventional therapy but are naïve to advanced therapies (ADT-naïve) or to advanced therapy defined as biologics and/or advanced oral agents approved for the treatment of CD (ADT-inadequate responder [ADT-IR]). 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease
  • Age: 18 years - 100 years
  • Gender: All

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, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or 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

This study investigates the effects of an investigational medication on people with moderately to severely active Crohn's disease, a long-term condition causing severe inflammation of the intestinal tract. The purpose is to see how well the medication works and how safe it is for the participants.

Participants will be randomly assigned to different study arms, with some receiving the investigational medication and others receiving a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will measure clinical response and remission at different time points using specific scoring systems.

  • Who can participate: Adults with a diagnosis of Crohn's Disease for at least 12 weeks with moderately to severely active disease based on specific criteria are eligible. Women of childbearing potential must have a negative pregnancy test, and participants must have had an inadequate response or intolerance to previous treatments.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The effects of the treatment will be assessed using specific scoring systems to measure disease activity and improvement.
Updated on 16 Mar 2026. Study ID: GI-JANSSEN-ICONIC-CD, 30492
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only