A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis

Study Purpose

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Must have completed the Week 16 visit in Protocol 77242113PSO2001.
  • - In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study.
  • - Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
  • - Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
  • - Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention.

Exclusion Criteria:

  • - Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason.
  • - Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001.
  • - Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention.
  • - Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention.
- Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

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.

NCT05364554
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 Not yet recruiting
Countries France, Germany, Japan, Spain, United States
Conditions

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

Plaque Psoriasis
Additional Details

The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.

Arms & Interventions

Arms

Experimental: Group 1: JNJ-77242113 Dose 1 Once Daily (QD)

Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.

Experimental: Group 2: JNJ-77242113 Dose 2 QD

Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.

Experimental: Group 3: JNJ-77242113 Dose 3 QD

Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Experimental: Group 4: JNJ-77242113 Dose 1 Twice Daily (BID)

Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.

Experimental: Group 5: JNJ-77242113 Dose 3 BID

Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.

Experimental: Group 6: JNJ-77242113 Dose 3 QD

Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.

Interventions

Drug: - JNJ-77242113

JNJ-77242113 tablet will be administered orally.

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.

Medical Dermatology Specialists, Phoenix, Arizona

Status

Address

Medical Dermatology Specialists

Phoenix, Arizona, 85006

Pacific Skin Institute, Sacramento, California

Status

Address

Pacific Skin Institute

Sacramento, California, 95815

Renstar Medical Research, Ocala, Florida

Status

Address

Renstar Medical Research

Ocala, Florida, 34470

Forcare Clinical Research, Inc., Tampa, Florida

Status

Address

Forcare Clinical Research, Inc.

Tampa, Florida, 33613

Olympian Clinical Research, Tampa, Florida

Status

Address

Olympian Clinical Research

Tampa, Florida, 33614

Alpharetta, Georgia

Status

Address

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, 30022

Arlington Dermatology, Rolling Meadows, Illinois

Status

Address

Arlington Dermatology

Rolling Meadows, Illinois, 60008

Indianapolis, Indiana

Status

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Indiana Clinical Trial Center, Plainfield, Indiana

Status

Address

Indiana Clinical Trial Center

Plainfield, Indiana, 46168

DermAssociates, PC, Rockville, Maryland

Status

Address

DermAssociates, PC

Rockville, Maryland, 20850

Hamzavi Dermatology, Fort Gratiot, Michigan

Status

Address

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059

Vivida Dermatology, Las Vegas, Nevada

Status

Address

Vivida Dermatology

Las Vegas, Nevada, 89119

Windsor Dermatology, PC, East Windsor, New Jersey

Status

Address

Windsor Dermatology, PC

East Windsor, New Jersey, 08520

Oregon Dermatology and Research Center, Portland, Oregon

Status

Address

Oregon Dermatology and Research Center

Portland, Oregon, 97210

Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, 15213

Modern Research Associates, Dallas, Texas

Status

Address

Modern Research Associates

Dallas, Texas, 75231

Center for Clinical Studies, Houston, Texas

Status

Address

Center for Clinical Studies

Houston, Texas, 77004

Austin Institute for Clinical Research, Pflugerville, Texas

Status

Address

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

Center for Clinical Studies, Webster, Texas

Status

Address

Center for Clinical Studies

Webster, Texas, 77598

University of Utah, Murray, Utah

Status

Address

University of Utah

Murray, Utah, 84107

Virginia Clinical Research, Norfolk, Virginia

Status

Address

Virginia Clinical Research

Norfolk, Virginia, 23502

Dermatology Associates, Seattle, Washington

Status

Address

Dermatology Associates

Seattle, Washington, 98101

Premier Clinical Research, Spokane, Washington

Status

Address

Premier Clinical Research

Spokane, Washington, 99202

International Sites

Centre Hospitalier Le Mans, Le Mans, France

Status

Address

Centre Hospitalier Le Mans

Le Mans, , 72037

Hopital Charles Nicolle, Rouen, France

Status

Address

Hopital Charles Nicolle

Rouen, , 76031

HIA Sainte Anne, Toulon, France

Status

Address

HIA Sainte Anne

Toulon, , 83800

Fachklinik Bad Bentheim, Bad Bentheim, Germany

Status

Address

Fachklinik Bad Bentheim

Bad Bentheim, , 48455

Berlin, Germany

Status

Address

Charite - Universitatsmedizin Berlin (CCM)

Berlin, , 10117

Rothhaar Studien GmbH, Berlin, Germany

Status

Address

Rothhaar Studien GmbH

Berlin, , 10783

Berlin, Germany

Status

Address

ISA - Interdisciplinary Study Association GmbH

Berlin, , 10789

Niesmann & Othlinghaus GbR, Bochum, Germany

Status

Address

Niesmann & Othlinghaus GbR

Bochum, , 44793

Rosenpark Research GmbH, Darmstadt, Germany

Status

Address

Rosenpark Research GmbH

Darmstadt, , 64283

Universitatsklinikum Frankfurt, Frankfurt am Main, Germany

Status

Address

Universitatsklinikum Frankfurt

Frankfurt am Main, , 60590

Derma-Study-Center Friedrichshafen GmbH, Friedrichshafen, Germany

Status

Address

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, , 88045

MensingDerma research GmbH, Hamburg, Germany

Status

Address

MensingDerma research GmbH

Hamburg, , 22391

Kiel, Germany

Status

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

Universitätsklinikum Leipzig AÖR, Leipzig, Germany

Status

Address

Universitätsklinikum Leipzig AÖR

Leipzig, , 04103

Mahlow, Germany

Status

Address

Gemeinschaftspraxis Scholz/Sebastian/Schilling

Mahlow, , 15831

Hautarztpraxis, Witten, Germany

Status

Address

Hautarztpraxis

Witten, , 58453

Yamanashi Prefectural Central Hospital, Kofu, Japan

Status

Address

Yamanashi Prefectural Central Hospital

Kofu, , 400-8506

Miyata Dermatology Clinic, Matsudo, Japan

Status

Address

Miyata Dermatology Clinic

Matsudo, , 271-0092

Takagi Clinic, Obihiro-shi, Japan

Status

Address

Takagi Clinic

Obihiro-shi, , 080-0013

Kume Clinic, Osaka Fu, Japan

Status

Address

Kume Clinic

Osaka Fu, , 593-8324

Sapporo Skin Clinic, Sapporo, Japan

Status

Address

Sapporo Skin Clinic

Sapporo, , 060-0063

Shizuoka Prefectural General Hospital, Shizuoka, Japan

Status

Address

Shizuoka Prefectural General Hospital

Shizuoka, , 420-8527

Shirasaki Dermatology Clinic, Takaoka, Japan

Status

Address

Shirasaki Dermatology Clinic

Takaoka, , 933-0871

Kumamoto Kenhoku Hospital, Tamana, Japan

Status

Address

Kumamoto Kenhoku Hospital

Tamana, , 865-0005

Toyama Prefectural Central Hospital, Toyama, Japan

Status

Address

Toyama Prefectural Central Hospital

Toyama, , 930-8550

Nomura Dermatology Clinic, Yokohama, Japan

Status

Address

Nomura Dermatology Clinic

Yokohama, , 221-0825

Hosp. Univ. Germans Trias I Pujol, Barcelona, Spain

Status

Address

Hosp. Univ. Germans Trias I Pujol

Barcelona, , 08916

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Provincial de Pontevedra, Pontevedra, Spain

Status

Address

Hosp. Provincial de Pontevedra

Pontevedra, , 36001

Hosp. Univ. I Politecni La Fe, Valencia, Spain

Status

Address

Hosp. Univ. I Politecni La Fe

Valencia, , 46026

Hosp. de Manises, Valencia, Spain

Status

Address

Hosp. de Manises

Valencia, , 46940

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