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
Janssen Research & Development, LLC
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 S…
Interventions
- DrugIcotrokinra
Icotrokinra will be administered orally, daily.
- DrugPlacebo
Matching placebo will be administered orally, daily.
Locations (358)
- AZ Gastro CareChandler, Arizona
- Mayo ClinicScottsdale, Arizona
- Clinnova ResearchAnaheim, California
- Alliance Research Institute, LLC - Canoga ParkCanoga Park, California
- Southern California Research CenterCoronado, California
- Om Research, LLC 1Lancaster, California