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Clinical Trials in South Korea / NCT07196722
Recruiting Phase 2/3

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

NCT07196722 · tracked via the Priya Life Science South Korea tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2/3
Started
2025-10-03
Last updated
2026-09-25

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Icotrokinra →Placebo

Icotrokinra: Icotrokinra will be administered orally, daily.

Placebo: Matching placebo will be administered orally, daily.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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 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

Primary outcome measure(s)

  • Induction Study 1: Number of Participants with Clinical Response at Week 12 — At Week 12
    Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
  • Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) — At Week 12
    Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
  • Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) — At Week 12
    Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
  • Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint) — At Week 40
    Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
  • Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint) — At Week 40
    Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

Trial sites (372)

FacilityCityRegionStatus
AZ Gastro Care Chandler Arizona Recruiting
Research Solutions of Arizona Litchfield Park Arizona Recruiting
Mayo Clinic Scottsdale Arizona Recruiting
Clinnova Research Anaheim California Recruiting
Alliance Research Institute, LLC - Canoga Park Canoga Park California Completed
Southern California Research Center Coronado California Recruiting
Om Research, LLC 1 Lancaster California Recruiting
TLC Clinical Research Inc Los Angeles California Recruiting
GastroIntestinal Bioscience Los Angeles California Recruiting
Hoag Memorial Hospital Newport Beach California Recruiting
Om Research, LLC 2 Oxnard California Recruiting
Clinical Applications Laboratories, Inc San Diego California Completed
Medical Associates Research Group, Inc. San Diego California Recruiting
University of California San Francisco San Francisco California Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
Nuvance Health Danbury Hospital Danbury Connecticut Completed
American Institute of Research Cutler Bay Florida Recruiting
Nature Coast Clinical Research Inverness Florida Recruiting
Green Leaf Clinical Trials Jacksonville Florida Completed
Florida Research Center Inc. Lakewood Rch Florida Recruiting
Sanchez Clinical Research, Inc Miami Florida Recruiting
GCP Clinical Research Tampa Florida Recruiting
Emory University Atlanta Georgia Recruiting
Children's Center for Digestive Health Care Atlanta Georgia Recruiting
Gastroenterolgy Associates of Central GA Macon Georgia Recruiting
IU Health University Hospital Indianapolis Indiana Recruiting
Kansas Gastroenterology, LLC Wichita Kansas Recruiting
Tri-State Gastroenterology Assoc Crestview Hills Kentucky Recruiting
University of Louisville - MedCenter One Louisville Kentucky Recruiting
Gastroenterology Clinic of Acadiana Lafayette Louisiana Recruiting
Delta Research Partners, LLC West Monroe Louisiana Recruiting
Chevy Chase Clinical Research Chevy Chase Maryland Recruiting
Woodholme Gastroenterology Associates Glen Burnie Maryland Recruiting
Mayo Clinic 1 Rochester Minnesota Recruiting
Westchester Putnam Gastroenterology Carmel New York Recruiting
Inflammatory Bowel Disease Center at NYU Langone New York New York Recruiting
Manhattan Clinical Research LLC New York New York Completed
Weill Cornell Medical College New York New York Recruiting
Lenox Hill Hospital New York New York Recruiting
New York Gastroenterology Associates New York New York Recruiting

+ 332 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in South Korea

Nipocalimab in Moderate to Severe Sjogren's Disease Active, not recruiting
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Active, not recruiting
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring Enrolling by invitation
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) Recruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease Recruiting

Other trials for the same condition

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial Recruiting
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease Recruiting
Predictors of Prognosis in IBD Patients Recruiting
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07196722 on ClinicalTrials.gov ↗ ← All trials in South Korea