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

NCT07196722

RecruitingPhase 2, Phase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Crohn Disease

Interventions: Icotrokinra, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (368)

Chandler, Arizona, United States
Litchfield Park, Arizona, United States
Scottsdale, Arizona, United States
Anaheim, California, United States
Canoga Park, California, United States
Coronado, California, United States
Lancaster, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Oxnard, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Colorado Springs, Colorado, United States
Danbury, Connecticut, United States
Cutler Bay, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Lakewood Rch, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Crestview Hills, Kentucky, United States
Lafayette, Louisiana, United States
West Monroe, Louisiana, United States
Chevy Chase, Maryland, United States
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