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Active, not recruiting Phase 3

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

NCT07196748 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-10-01
Last updated
2026-11-03

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Icotrokinra →Placebo

Icotrokinra: Icotrokinra tablet will be administered orally.

Placebo: Placebo tablet will be administered orally.

Study summary

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC * Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy * An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy * Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0) * Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) 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 are naïve to advanced therapies (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 UC (ADT-inadequate responder \[IR\]) as defined in the protocol Exclusion Criteria: * Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study * Presence of a stoma * Presence or history of a fistula * Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline * History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention

Primary outcome measure(s)

  • Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 — At Week I-12
    Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
  • DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 — At Week M-40
    Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
  • Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 — At Week M-40
    Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

Trial sites (402)

FacilityCityRegionStatus
AZ Gastro Care Chandler Arizona
Research Solutions of Arizona Litchfield Park Arizona
Mayo Clinic Scottsdale Arizona
Clinnova Research Anaheim California
Southern California Research Center Coronado California
Om Research LLC Lancaster California
TLC Clinical Research Inc Los Angeles California
GastroIntestinal Bioscience Los Angeles California
Hoag Memorial Hospital Newport Beach California
Om Research LLC 2 Oxnard California
Stanford Medicine Children's Health Palo Alto California
Clinical Applications Laboratories, Inc San Diego California
Medical Associates Research Group, Inc. San Diego California
University of California San Francisco San Francisco California
Peak Gastroenterology Associates Colorado Springs Colorado
Nuvance Health Danbury Hospital Danbury Connecticut
Connecticut Children's Medical Center Hartford Connecticut
American Institute of Research Cutler Bay Florida
Nature Coast Clinical Research Inverness Florida
Florida Research Institute Lakewood Rch Florida
GCP Clinical Research Tampa Florida
Atlanta Gastroenterology Associates Atlanta Georgia
Children's Center for Digestive Health Care Atlanta Georgia
Gastroenterolgy Associates of Central GA Macon Georgia
IU Health University Hospital Indianapolis Indiana
Cotton O'Neil Digestive Health Center Topeka Kansas
Tri-State Gastroenterology Assoc Crestview Hills Kentucky
Delta Research Partners, LLC West Monroe Louisiana
Chevy Chase Clinical Research Chevy Chase Maryland
Woodholme Gastroenterology Associates Glen Burnie Maryland
Westchester Putnam Gastroenterology Carmel New York
Inflammatory Bowel Disease Center at NYU Langone New York New York
Manhattan Clinical Research LLC New York New York
Icahn School of Medicine at Mount Sinai New York New York
Weill Cornell Medical College New York New York
Lenox Hill Hospital New York New York
New York Gastroenterology Associates New York New York
University of North Carolina Chapel Hill North Carolina
Atrium Health Charlotte North Carolina
Digestive Disease Specialists Inc Oklahoma City Oklahoma

+ 362 more sites — see the full list on the official registry below.

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 NCT07196748 on ClinicalTrials.gov ↗ ← All trials in China