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Recruiting
NCT07196722
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Conditions: Crohn Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 1092
Sponsor: Janssen Research & Development, LLC
Location: AZ Gastro Care Chandler Arizona
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 condition causing severe inflammation of the intestinal tract).
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 \=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
Source: ClinicalTrials.gov (NCT07196722). StuddyBuddy aggregates publicly available trial information.