Tests icotrokinra against placebo in adults with active Crohn's disease
Tests icotrokinra in adults with moderately to severely active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Anaheim, Atlanta, Austin, Canoga Park, Carmel, Carrollton, Chandler, Chapel Hill, Charleston, Charlotte, Chesapeake, Chevy Chase, Colorado Springs, Coronado, Crestview Hills, Cutler Bay, Dallas, Danbury, Glen Burnie, Harrisburg, Hershey, Houston, Indianapolis, Inverness, Jacksonville, Lafayette, Lakewood Rch, Lancaster, Litchfield Park, Los Angeles, Louisville, Lynchburg, Macon, Miami, Milwaukee, New York, Newport Beach, Oklahoma City, Oxnard, Philadelphia, Portland, Providence, Rochester, Rock Hill, San Antonio, San Diego, San Francisco, Scottsdale, Southlake, Tacoma, Tampa, Tyler, West Monroe, and Wichita, United StatesSee the 64 sites
- Phase
- Phase 2/3
Where in United States
- Clinnova ResearchAnaheim, United StatesTaking people
- Atlanta Gastroenterology AssociatesAtlanta, United StatesTaking people
- Children's Center for Digestive Health CareAtlanta, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- The University of Texas at AustinAustin, United StatesTaking people
- Alliance Research Institute, LLC - Canoga ParkCanoga Park, United StatesNo longer taking part
- Westchester Putnam GastroenterologyCarmel, United StatesTaking people
- DFW Clinical TrialsCarrollton, United StatesTaking people
- AZ Gastro CareChandler, United StatesTaking people
- University of North CarolinaChapel Hill, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Atrium HealthCharlotte, United StatesTaking people
- Gastroenterology Associates of TidewaterChesapeake, United StatesTaking people
- Chevy Chase Clinical ResearchChevy Chase, United StatesTaking people
- Peak Gastroenterology AssociatesColorado Springs, United StatesTaking people
- Southern California Research CenterCoronado, United StatesTaking people
- Tri-State Gastroenterology AssocCrestview Hills, United StatesTaking people
- American Institute of ResearchCutler Bay, United StatesTaking people
- Baylor University Medical CenterDallas, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- Nuvance Health-Danbury HospitalDanbury, United StatesNo longer taking part
- Woodholme Gastroenterology AssociatesGlen Burnie, United StatesTaking people
- Susquehanna Research GroupHarrisburg, United StatesTaking people
- Penn State Milton S Hershey Medical CtrHershey, United StatesTaking people
- Victorium Clinical ResearchHouston, United StatesTaking people
- IU Health University HospitalIndianapolis, United StatesTaking people
- Nature Coast Clinical ResearchInverness, United StatesTaking people
- Green Leaf Clinical TrialsJacksonville, United StatesNo longer taking part
- Gastroenterology Clinic of AcadianaLafayette, United StatesTaking people
- Florida Research Center Inc.Lakewood Rch, United StatesTaking people
- Om Research, LLC 1Lancaster, United StatesTaking people
- Research Solutions of ArizonaLitchfield Park, United StatesTaking people
- GastroIntestinal BioscienceLos Angeles, United StatesTaking people
- TLC Clinical Research IncLos Angeles, United StatesTaking people
- University of Louisville - MedCenter OneLouisville, United StatesTaking people
- Blue Ridge Medical ResearchLynchburg, United StatesTaking people
- Gastroenterolgy Associates of Central GAMacon, United StatesTaking people
- Sanchez Clinical Research ,IncMiami, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Inflammatory Bowel Disease Center at NYU LangoneNew York, United StatesTaking people
- Lenox Hill HospitalNew York, United StatesTaking people
- New York Gastroenterology AssociatesNew York, United StatesTaking people
- Weill Cornell Medical CollegeNew York, United StatesTaking people
- Manhattan Clinical Research, LLCNew York, United StatesNo longer taking part
- Hoag Memorial HospitalNewport Beach, United StatesTaking people
- Digestive Disease Specialists, IncOklahoma City, United StatesNo longer taking part
- Om Research, LLC 2Oxnard, United StatesTaking people
- Jefferson Digestive Health InstitutePhiladelphia, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- The Oregon ClinicPortland, United StatesTaking people
- University GastroenterologyProvidence, United StatesTaking people
- Mayo Clinic 1Rochester, United StatesTaking people
- Digestive Disease AssociatesRock Hill, United StatesNo longer taking part
- Southern Star Research Institute, LLCSan Antonio, United StatesTaking people
- Medical Associates Research Group, Inc.San Diego, United StatesTaking people
- Clinical Applications Laboratories, Inc.San Diego, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesTaking people
- Mayo ClinicScottsdale, United StatesTaking people
- GI Alliance - SouthlakeSouthlake, United StatesTaking people
- GI Alliance TacomaTacoma, United StatesTaking people
- GCP Clinical ResearchTampa, United StatesTaking people
- Tyler Research Institute, LLCTyler, United StatesTaking people
- Delta Research Partners, LLCWest Monroe, United StatesTaking people
- Kansas Gastroenterology, LLCWichita, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07196722EU 2025-521382-27-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
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: 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; 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; Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization.