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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

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, 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 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 5289282, Arizona 5551752 85206

Clinnova Research
Anaheim 5323810, California 5332921 92805

Alliance Research Institute, LLC - Canoga Park
Canoga Park 5333913, California 5332921 91304

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

American Institute of Research
Cutler Bay 6332309, Florida 4155751 33157

Nature Coast Clinical Research
Inverness 4159786, Florida 4155751 34452

Green Leaf Clinical Trials
Jacksonville 4160021, Florida 4155751 32258

Florida Research Center Inc.
Lakewood Rch 7255365, Florida 4155751 34211

Sanchez Clinical Research, Inc
Miami 4164138, Florida 4155751 33157-6575

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

Kansas Gastroenterology, LLC
Wichita 4281730, Kansas 4273857 67226

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

Gastroenterology Clinic of Acadiana
Lafayette 4330145, Louisiana 4331987 70503

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.