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 (401)
Facility
City
Region
Status
AZ Gastro Care
Chandler
Arizona
Recruiting
Research Solutions of Arizona
Litchfield Park
Arizona
Recruiting
Mayo Clinic
Scottsdale
Arizona
Recruiting
Clinnova Research
Anaheim
California
Recruiting
Southern California Research Center
Coronado
California
Recruiting
Om Research LLC
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
Connecticut Children's Medical Center
Hartford
Connecticut
Recruiting
American Institute of Research
Cutler Bay
Florida
Recruiting
Nature Coast Clinical Research
Inverness
Florida
Recruiting
Florida Research Institute
Lakewood Rch
Florida
Recruiting
GCP Clinical Research
Tampa
Florida
Recruiting
Atlanta Gastroenterology Associates
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
Cotton O'Neil Digestive Health Center
Topeka
Kansas
Recruiting
Tri-State Gastroenterology Assoc
Crestview Hills
Kentucky
Recruiting
Delta Research Partners, LLC
West Monroe
Louisiana
Recruiting
Chevy Chase Clinical Research
Chevy Chase
Maryland
Recruiting
Woodholme Gastroenterology Associates
Glen Burnie
Maryland
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
Icahn School of Medicine at Mount Sinai
New York
New York
Recruiting
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
University of North Carolina
Chapel Hill
North Carolina
Recruiting
Atrium Health
Charlotte
North Carolina
Recruiting
Digestive Disease Specialists Inc
Oklahoma City
Oklahoma
Completed
The Oregon Clinic
Portland
Oregon
Recruiting
+ 361 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
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.
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