Status:
RECRUITING
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 6 2032
Estimated Enrollment :
1092 Patients enrolled
Trial Details
Trial ID
NCT07196722
Start Date
October 3 2025
End Date
October 6 2032
Last Update
March 12 2026
Active Locations (324)
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1
AZ Gastro Care
Chandler, Arizona, United States, 85206
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
Clinnova Research
Anaheim, California, United States, 92805
4
Alliance Research Institute, LLC - Canoga Park
Canoga Park, California, United States, 91304