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 - For adolescent participants >=12 to less than (<) 18 years of age, 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, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or 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 5289282, Arizona 5551752 85206

Clinnova Research
Anaheim 5323810, California 5332921 92805

Southern California Research Center
Coronado 5339663, California 5332921 92118

Om Research LLC
Lancaster 5364940, California 5332921 93534

TLC Clinical Research Inc
Los Angeles 5368361, California 5332921 90048

GastroIntestinal Bioscience
Los Angeles 5368361, California 5332921 90067

Om Research LLC
Oxnard 5380184, California 5332921 93030

Clinical Applications Laboratories, Inc
San Diego 5391811, California 5332921 92103

Medical Associates Research Group, Inc.
San Diego 5391811, California 5332921 92123

Peak Gastroenterology Associates
Colorado Springs 5417598, Colorado 5417618 80907

Nuvance Health Danbury Hospital
Danbury 4832353, Connecticut 4831725 06810

American Institute of Research
Cutler Bay 6332309, Florida 4155751 33157

Nature Coast Clinical Research
Inverness 4159786, Florida 4155751 34452

Florida Research Institute
Lakewood Rch 7255365, Florida 4155751 34211

GCP Clinical Research
Tampa 4174757, Florida 4155751 33609

Children's Center for Digestive Health Care
Atlanta 4180439, Georgia 4197000 30342

Gastroenterolgy Associates of Central GA
Macon 4207400, Georgia 4197000 31201

Cotton O'Neil Digestive Health Center
Topeka 4280539, Kansas 4273857 66606

Tri-State Gastroenterology Assoc
Crestview Hills 4289040, Kentucky 6254925 41017

Delta Research Partners, LLC
West Monroe 4345850, Louisiana 4331987 71291

Westchester Putnam Gastroenterology
Carmel 5111576, New York 5128638 10512

Manhattan Clinical Research LLC
New York 5128581, New York 5128638 10016

New York Gastroenterology Associates
New York 5128581, New York 5128638 10075

Digestive Disease Specialists Inc
Oklahoma City 4544349, Oklahoma 4544379 73114

The Oregon Clinic
Portland 5746545, Oregon 5744337 97220-9428

Susquehanna Research Group
Harrisburg 5192726, Pennsylvania 6254927 17110-3673

Digestive Disease Associates
Rock Hill 4593142, South Carolina 4597040 29732

DFW Clinical Trials
Carrollton 4679195, Texas 4736286 75010

Victorium Clinical Research
Houston 4699066, Texas 4736286 77024

Southern Star Research Institute, LLC
San Antonio 4726206, Texas 4736286 78229

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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