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

Purpose

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).

Condition

  • Colitis, Ulcerative

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel assignment applies to adult participants only.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
This study is double-blind for adults and open-label for adolescent participants.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Double-blind (DB) Induction Study: Icotrokinra 		Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
  • Drug: Icotrokinra
    Icotrokinra tablet will be administered orally.
    Other names:
    • JNJ-77242113
Placebo Comparator
DB Induction Study: Placebo 		Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
  • Drug: Placebo
    Placebo tablet will be administered orally.
Experimental
DB Maintenance Study: Icotrokinra 		Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
  • Drug: Icotrokinra
    Icotrokinra tablet will be administered orally.
    Other names:
    • JNJ-77242113
Placebo Comparator
DB Maintenance Study: Placebo 		Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
  • Drug: Placebo
    Placebo tablet will be administered orally.
Experimental
Open-label (OL) Induction Phase: Icotrokinra 		Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
  • Drug: Icotrokinra
    Icotrokinra tablet will be administered orally.
    Other names:
    • JNJ-77242113
Experimental
OL Maintenance Phase: Icotrokinra 		Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.
  • Drug: Icotrokinra
    Icotrokinra tablet will be administered orally.
    Other names:
    • JNJ-77242113

Recruiting Locations

AZ Gastro Care
Chandler, Arizona 85206

Research Solutions of Arizona
Litchfield Park, Arizona 85340

Mayo Clinic
Scottsdale, Arizona 85259

Clinnova Research
Anaheim, California 92805

Southern California Research Center
Coronado, California 92118

Om Research LLC
Lancaster, California 93534

TLC Clinical Research Inc
Los Angeles, California 90048

GastroIntestinal Bioscience
Los Angeles, California 90067

Om Research LLC 2
Oxnard, California 93030

Clinical Applications Laboratories, Inc
San Diego, California 92103

Medical Associates Research Group, Inc.
San Diego, California 92123

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907

Nuvance Health Danbury Hospital
Danbury, Connecticut 06810

Connecticut Children's Medical Center
Hartford, Connecticut 06106

American Institute of Research
Cutler Bay, Florida 33157

Nature Coast Clinical Research
Inverness, Florida 34452

Florida Research Institute
Lakewood Rch, Florida 34211

GCP Clinical Research
Tampa, Florida 33609

Atlanta Gastroenterology Associates
Atlanta, Georgia 30342

Children's Center for Digestive Health Care
Atlanta, Georgia 30342

Gastroenterolgy Associates of Central GA
Macon, Georgia 31201

Cotton O'Neil Digestive Health Center
Topeka, Kansas 66606

Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky 41017

Delta Research Partners, LLC
West Monroe, Louisiana 71291

Chevy Chase Clinical Research
Chevy Chase, Maryland 20815

Woodholme Gastroenterology Associates
Glen Burnie, Maryland 21061

Westchester Putnam Gastroenterology
Carmel, New York 10512

Inflammatory Bowel Disease Center at NYU Langone
New York, New York 10016

Manhattan Clinical Research LLC
New York, New York 10016

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Weill Cornell Medical College
New York, New York 10065

Lenox Hill Hospital
New York, New York 10075

New York Gastroenterology Associates
New York, New York 10075

University of North Carolina
Chapel Hill, North Carolina 27599

Atrium Health
Charlotte, North Carolina 28204

Digestive Disease Specialists Inc
Oklahoma City, Oklahoma 73114

The Oregon Clinic
Portland, Oregon 97220-9428

Susquehanna Research Group
Harrisburg, Pennsylvania 17110-3673

Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania 17033

University of Pennsylvania
Philadelphia, Pennsylvania 19104

Jefferson Digestive Health Institute
Philadelphia, Pennsylvania 19107

University Gastroenterology
Providence, Rhode Island 02905

Digestive Disease Associates
Rock Hill, South Carolina 29732

The University of Texas at Austin
Austin, Texas 78712

DFW Clinical Trials
Carrollton, Texas 75010

Victorium Clinical Research
Houston, Texas 77024

Southern Star Research Institute, LLC
San Antonio, Texas 78229

GI Alliance Southlake
Southlake, Texas 76092

Tyler Research Institute, LLC
Tyler, Texas 75701

Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320

Blue Ridge Medical Research
Lynchburg, Virginia 24502

GI Alliance Tacoma
Tacoma, Washington 98405

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com