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

Purpose

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).

Condition

  • Crohn Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Induction Study 1: Icotrokinra Dose 1 		Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
  • Drug: Icotrokinra
    Icotrokinra will be administered orally, daily.
    Other names:
    • JNJ-77242113
Experimental
Induction Study 1: Icotrokinra Dose 2 		Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
  • Drug: Icotrokinra
    Icotrokinra will be administered orally, daily.
    Other names:
    • JNJ-77242113
Placebo Comparator
Induction Study 1: Placebo 		Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
  • Drug: Placebo
    Matching placebo will be administered orally, daily.
Experimental
Induction Study 2: Icotrokinra 		Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
  • Drug: Icotrokinra
    Icotrokinra will be administered orally, daily.
    Other names:
    • JNJ-77242113
Placebo Comparator
Induction Study 2: Placebo 		Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
  • Drug: Placebo
    Matching placebo will be administered orally, daily.
Experimental
Maintenance Study: Icotrokinra Dose 1 		Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
  • Drug: Icotrokinra
    Icotrokinra will be administered orally, daily.
    Other names:
    • JNJ-77242113
Experimental
Maintenance Study: Icotrokinra Dose 2 		Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
  • Drug: Icotrokinra
    Icotrokinra will be administered orally, daily.
    Other names:
    • JNJ-77242113
Placebo Comparator
Maintenance Study: Placebo 		Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
  • Drug: Icotrokinra
    Icotrokinra will be administered orally, daily.
    Other names:
    • JNJ-77242113
  • Drug: Placebo
    Matching placebo will be administered orally, daily.

Recruiting Locations

AZ Gastro Care
Chandler, Arizona 85206

Mayo Clinic
Scottsdale, Arizona 85259

Clinnova Research
Anaheim, California 92805

Alliance Research Institute, LLC - Canoga Park
Canoga Park, California 91304

Southern California Research Center
Coronado, California 92118

Om Research, LLC 1
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

University of California San Francisco
San Francisco, California 94115

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907

Nuvance Health Danbury Hospital
Danbury, Connecticut 06810

American Institute of Research
Cutler Bay, Florida 33157

Nature Coast Clinical Research
Inverness, Florida 34452

Green Leaf Clinical Trials
Jacksonville, Florida 32258

Florida Research Center Inc.
Lakewood Rch, Florida 34211

Sanchez Clinical Research, Inc
Miami, Florida 33157-6575

GCP Clinical Research
Tampa, Florida 33609

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

Gastroenterolgy Associates of Central GA
Macon, Georgia 31201

IU Health University Hospital
Indianapolis, Indiana 46202

Kansas Gastroenterology, LLC
Wichita, Kansas 67226

Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky 41017

Gastroenterology Clinic of Acadiana
Lafayette, Louisiana 70503

Delta Research Partners, LLC
West Monroe, Louisiana 71291

Chevy Chase Clinical Research
Chevy Chase, Maryland 20815

Woodholme Gastroenterology Associates
Glen Burnie, Maryland 21061

Mayo Clinic 1
Rochester, Minnesota 55905

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

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

Baylor University Medical Center
Dallas, Texas 75246

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