A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in participants with active Crohn's disease in response but not remission to SOC biologic therapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have confirmed clinical diagnosis of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration.
  • - Initiated standard of care (SOC) biologic therapy for at least 12 uninterrupted weeks (including the induction dose) prior to Week 0 and agree to continue to maintain their SOC biologic with no change in dose level or interruption for the duration of the study.
Adalimumab (including HUMIRA or an equivalent biosimilar which could include: HULIO, HYRIMOZ, IMRALDI, or AMGEVITA) at maintenance dose of 40 milligram (mg) subcutaneous (SC) every 2 weeks (q2w) plus minus (+ -) 4 days or Ustekinumab at maintenance dose of 90 mg SC every 8 weeks (q8w) +
  • - 7 days.
  • - Have active Crohn's disease (CD), with a baseline crohn's disease activity index (CDAI) score of greater than or equal to (>=) 180 but less than or equal to (<=) 400.
  • - Participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age greater than (>) 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance.
  • - Participant who has had extensive colitis for >=8 years, or disease limited to the left side of the colon for >=12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy.
  • - A woman of childbearing potential must have a negative highly sensitive serum (beta- human chorionic gonadotropin [beta-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0 and throughout the study.

Exclusion Criteria:

  • - Has complications of Crohn's disease as defined in study protocol.
  • - Currently has or is suspected to have an abscess.
  • - Concomitant or previous medical therapies received: has previously demonstrated suboptimal response, loss of response, or intolerance to more than 2 approved advanced therapies.
  • - Concomitant or previous medical therapies received: corticosteroids and 5-aminosalicylic acid (5-ASA) compounds at unstable or above recommended doses are not permitted.
Individuals receiving stable doses (oral corticosteroids at a prednisone-equivalent dose at or below 20 mg/day, or 6 mg/day of budesonide, 2.5 mg/day beclomethasone dipropionate, or at or below 5-ASA doses of 1.5 gram (g)/day) or if individuals have been discontinued, for at least 2 weeks before start of first study intervention (Week 0), are permitted.
  • - Concomitant or previous medical therapies received: has received any of the following prescribed medications or therapies within the specified period or has plans to initiate throughout the study: conventional immunomodulators (that is , azathioprine [AZA], 6-mercaptopurine [6 MP], or methotrexate [MTX]) within 4 weeks of first dose of study intervention; oral immunomodulatory agents (example, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil, tofacitinib and other Janus kinase [JAK] inhibitors [including investigational JAK inhibitors]) less than (<) 6 weeks or within 5 half-lives of agent before first dose of SOC biologic, whichever is longer; all other immunomodulatory biologic agents (including investigational biologics) received within 12 weeks or within 5 half-lives of first dose of SOC biologic, whichever is longer.
  • - Infections or predisposition to infections criteria: has a stool culture or other examination positive for an enteric pathogen, including clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
- Has a transplanted organ (with exception of a corneal transplant that needs to have occurred > 12 weeks before screening)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04655807
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, France, Germany, Italy, Japan, Spain, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Additional Details

Biologic agents such as anti-tumor necrosis factor (TNF) and interleukin (IL)-12/23 antagonists have become the standard of care (SOC) in the treatment of patients with Crohn's disease. However, many patients fail to fully respond to treatment. This study will evaluate the efficacy of 10 week add on treatment with JNJ-64304500, compared to placebo, in patients taking SOC anti-TNF or anti-IL12/23 biologics. The study consists of a screening phase (up to 8 weeks); treatment phase (up to 12 weeks and follow-up phase (up to 16 weeks after the last administration of study agent). The total study duration will be up to 34 weeks. Key safety assessments include adverse events, clinical laboratory tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis.

Arms & Interventions

Arms

Experimental: Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab

Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.

Experimental: Group 2: SOC Biological Therapy: Ustekinumab

Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.

Interventions

Drug: - JNJ-64304500

JNJ-64304500 will be administered as SC injection.

Drug: - Placebo

Matching placebo will be administered as SC injection.

Drug: - Adalimumab

Adalimumab will be administered as SOC biological therapy.

Drug: - Ustekinumab

Ustekinumab will be administered as SOC biological therapy.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Not yet recruiting

Address

University of California, San Francisco

San Francisco, California, 94115

Medical Research Center of Connecticut, Hamden, Connecticut

Status

Not yet recruiting

Address

Medical Research Center of Connecticut

Hamden, Connecticut, 06518

Medisphere Medical Research Center, Llc, Evansville, Indiana

Status

Recruiting

Address

Medisphere Medical Research Center, Llc

Evansville, Indiana, 47714

University Of Minnesota, Minneapolis, Minnesota

Status

Not yet recruiting

Address

University Of Minnesota

Minneapolis, Minnesota, 55455

Atlantic Health System, Morristown, New Jersey

Status

Not yet recruiting

Address

Atlantic Health System

Morristown, New Jersey, 07960

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

The University of Texas at Austin, Austin, Texas

Status

Not yet recruiting

Address

The University of Texas at Austin

Austin, Texas, 78712

DHAT Research Institute, Garland, Texas

Status

Not yet recruiting

Address

DHAT Research Institute

Garland, Texas, 75044

Baylor College of Medicine, Houston, Texas

Status

Not yet recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Lynchburg, Virginia

Status

Not yet recruiting

Address

Gastroenterology Associates of Central Virginia

Lynchburg, Virginia, 24502

University of Washington, Seattle, Washington

Status

Not yet recruiting

Address

University of Washington

Seattle, Washington, 98195

International Sites

University of Calgary, Calgary, Alberta, Canada

Status

Not yet recruiting

Address

University of Calgary

Calgary, Alberta, T2N 4Z6

London Health Sciences Centre, London, Ontario, Canada

Status

Not yet recruiting

Address

London Health Sciences Centre

London, Ontario, N6A 5A5

Toronto, Ontario, Canada

Status

Not yet recruiting

Address

Toronto Immune & Digestive Health Institute Inc.

Toronto, Ontario, M6A 3B4

McGill University Health Centre, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

McGill University Health Centre

Montreal, Quebec, H3G 1A4

CHU Grenoble, Grenoble Cedex 9, France

Status

Not yet recruiting

Address

CHU Grenoble

Grenoble Cedex 9, , 38043

CHRU de Lille - Hôpital Claude Huriez, Lille, France

Status

Withdrawn

Address

CHRU de Lille - Hôpital Claude Huriez

Lille, , 59037

Aphm - Hopital Nord, Marseille, France

Status

Withdrawn

Address

Aphm - Hopital Nord

Marseille, , 13915

Hopital Saint Eloi, Montpellier, France

Status

Not yet recruiting

Address

Hopital Saint Eloi

Montpellier, , 34295

CHU de Nantes hôtel-Dieu, Nantes, France

Status

Withdrawn

Address

CHU de Nantes hôtel-Dieu

Nantes, , 44093

Hopital Saint-Louis, Paris, France

Status

Not yet recruiting

Address

Hopital Saint-Louis

Paris, , 75010

Hopital Haut-Leveque, CMC Magellan, Pessac, France

Status

Withdrawn

Address

Hopital Haut-Leveque, CMC Magellan

Pessac, , 33604

Centre Hospitalier Lyon Sud, Pierre-Bénite, France

Status

Withdrawn

Address

Centre Hospitalier Lyon Sud

Pierre-Bénite, , 69495

CHU Saint-Etienne - Hôpital Nord, Saint-Priest en Jarez, France

Status

Not yet recruiting

Address

CHU Saint-Etienne - Hôpital Nord

Saint-Priest en Jarez, , 42270

CHU Rangueil, Toulouse, France

Status

Withdrawn

Address

CHU Rangueil

Toulouse, , 31059

Klinikum Augsburg, Augsburg, Germany

Status

Not yet recruiting

Address

Klinikum Augsburg

Augsburg, , D-86158

GASTRO-Studien, Berlin, Germany

Status

Not yet recruiting

Address

GASTRO-Studien

Berlin, , 10825

Frankfurt, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Frankfurt/ Medizinische Klinik 1

Frankfurt, , 60590

Gastroenterologie Opernstraße, Kassel, Germany

Status

Not yet recruiting

Address

Gastroenterologie Opernstraße

Kassel, , 34117

Klinik für Innere Medizin II, München, Germany

Status

Not yet recruiting

Address

Klinik für Innere Medizin II

München, , 81675

Saarbrücken, Germany

Status

Not yet recruiting

Address

Zentrum für Gastroenterologie Saar MVZ GmbH

Saarbrücken, , 66111

Universitaetsklinik Tuebingen, Tübingen, Germany

Status

Not yet recruiting

Address

Universitaetsklinik Tuebingen

Tübingen, , 72076

Ulm, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Ulm, Klinik für Innere Medizin II

Ulm, , 89081

Milano, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, , 20122

Negrar ( Ve), Italy

Status

Not yet recruiting

Address

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

Negrar ( Ve), , 37024

Rome, Italy

Status

Not yet recruiting

Address

Policlinico Universitario Campus Biomedico

Rome, , 00128

Rome, Italy

Status

Not yet recruiting

Address

Policlinico Universitario Agostino Gemelli

Rome, , 00168

Istituto Clinico Humanitas, Rozzano, Italy

Status

Not yet recruiting

Address

Istituto Clinico Humanitas

Rozzano, , 20089

Casa Sollievo della Sofferenza, IRCCS, San Giovanni Rotondo, Italy

Status

Not yet recruiting

Address

Casa Sollievo della Sofferenza, IRCCS

San Giovanni Rotondo, , 71013

Gunma University Hospital, Gunma, Japan

Status

Not yet recruiting

Address

Gunma University Hospital

Gunma, , 371-0034

Kagoshima University Hospital, Kagoshima, Japan

Status

Not yet recruiting

Address

Kagoshima University Hospital

Kagoshima, , 890-8520

Matsushima Clinic, Kanagawa, Japan

Status

Withdrawn

Address

Matsushima Clinic

Kanagawa, , 220-0045

Kanazawa University Hospital, Kanazawa, Japan

Status

Not yet recruiting

Address

Kanazawa University Hospital

Kanazawa, , 920-8641

Minato-ku, Japan

Status

Not yet recruiting

Address

Kitasato University Kitasato Institute Hospital

Minato-ku, , 108-8642

Niigata, Japan

Status

Not yet recruiting

Address

Niigata University Medical & Dental Hospital

Niigata, , 951-8520

Kindai University Hospital, Osaka-Sayama, Japan

Status

Not yet recruiting

Address

Kindai University Hospital

Osaka-Sayama, , 589-8511

Kinshukai Infusion Clinic, Osaka, Japan

Status

Not yet recruiting

Address

Kinshukai Infusion Clinic

Osaka, , 530-0011

Tohoku University Hospital, Sendai, Japan

Status

Not yet recruiting

Address

Tohoku University Hospital

Sendai, , 980-8574

Matsuda Hospital, Shizuoka, Japan

Status

Not yet recruiting

Address

Matsuda Hospital

Shizuoka, , 432-8061

Osaka University Hospital, Suita, Japan

Status

Not yet recruiting

Address

Osaka University Hospital

Suita, , 565-0871

Tokyo, Japan

Status

Not yet recruiting

Address

National Center for Global Health and Medicine

Tokyo, , 162-8655

Tokyo Yamate Medical Center, Tokyo, Japan

Status

Not yet recruiting

Address

Tokyo Yamate Medical Center

Tokyo, , 169-0073

Hosp. Univ. Fundacion Alcorcon, Alcorcón, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Fundacion Alcorcon

Alcorcón, , 28922

Hosp. Arquitecto Marcide, Ferrol, Spain

Status

Not yet recruiting

Address

Hosp. Arquitecto Marcide

Ferrol, , 15405

Hosp. Univ. de La Princesa, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Univ. de La Princesa

Madrid, , 28006

Hosp. de Navarra, Pamplona, Spain

Status

Not yet recruiting

Address

Hosp. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Not yet recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46010

Hosp. Alvaro Cunqueiro, Vigo, Spain

Status

Not yet recruiting

Address

Hosp. Alvaro Cunqueiro

Vigo, , 36312

Hosp. Univ. Miguel Servet, Zaragoza, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Miguel Servet

Zaragoza, , 50009

Linkoping University Hospital, Linköping, Sweden

Status

Withdrawn

Address

Linkoping University Hospital

Linköping, , 18185

Orebro universitetssjukhus, Orebro, Sweden

Status

Withdrawn

Address

Orebro universitetssjukhus

Orebro, ,

Gastromottagningen, Stockholm, Sweden

Status

Withdrawn

Address

Gastromottagningen

Stockholm, , 18288

Ersta sjukhus, Stockholm, Sweden

Status

Withdrawn

Address

Ersta sjukhus

Stockholm, , SE-11691

Karolinska Universitetssjukhuset, Stockholm, Sweden

Status

Withdrawn

Address

Karolinska Universitetssjukhuset

Stockholm, , SE-171 76

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