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

NCT ID: NCT05364554

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2023-09-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Interventions

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JNJ-77242113

JNJ-77242113 tablet will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Pacific Skin Institute

Sacramento, California, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Forcare Clinical Research Inc

Tampa, Florida, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

Indiana Clinical Trial Center

Plainfield, Indiana, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Vivida Dermatology

Las Vegas, Nevada, United States

Site Status

Windsor Dermatology, PC

East Windsor, New Jersey, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, United States

Site Status

Modern Research Associates

Dallas, Texas, United States

Site Status

Center for Clinical Studies

Houston, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Dermatrials Research

Hamilton, Ontario, Canada

Site Status

Alliance Clinical Trials

Waterloo, Ontario, Canada

Site Status

XLR8 Medical Research

Windsor, Ontario, Canada

Site Status

Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Le Mans

Le Mans, , France

Site Status

Hopital Charles Nicolle

Rouen, , France

Site Status

HIA Sainte Anne

Toulon, , France

Site Status

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Site Status

ISA - Interdisciplinary Study Association GmbH

Berlin, , Germany

Site Status

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Site Status

Niesmann & Othlinghaus GbR

Bochum, , Germany

Site Status

Rosenpark Research GmbH

Darmstadt, , Germany

Site Status

Universitatsklinikum Frankfurt

Frankfurt am Main, , Germany

Site Status

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, , Germany

Site Status

MensingDerma research GmbH

Hamburg, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitatsklinikum Schleswig Holstein Kiel

Kiel, , Germany

Site Status

Gemeinschaftspraxis Scholz/Sebastian/Schilling

Mahlow, , Germany

Site Status

Hautarztpraxis

Witten, , Germany

Site Status

Takagi Dermatological Clinic

Obihiro-shi, , Japan

Site Status

Kume Clinic

Sakai, , Japan

Site Status

Sapporo Skin Clinic

Sapporo, , Japan

Site Status

Shizuoka General Hospital

Shizuoka, , Japan

Site Status

Shirasaki Dermatology Clinic

Takaoka, , Japan

Site Status

Toyama Prefectural Central Hospital

Toyama, , Japan

Site Status

Nomura Dermatology Clinic

Yokohama, , Japan

Site Status

Nzoz Zdrowie Osteo-Medic

Bialystok, , Poland

Site Status

Dermed Centrum Medyczne Sp z o o

Lodz, , Poland

Site Status

Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C

Osielsko, , Poland

Site Status

Klinika Ambroziak Estederm Sp. z o.o

Warsaw, , Poland

Site Status

Wro Medica

Wroclaw, , Poland

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

KyungHee University Hospital

Seoul, , South Korea

Site Status

Hosp. Univ. Germans Trias I Pujol

Barcelona, , Spain

Site Status

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Site Status

Hosp. de Manises

Valencia, , Spain

Site Status

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, , Taiwan

Site Status

Guys and St Thomas NHS Foundation Trust

London, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

Countries

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United States Canada France Germany Japan Poland South Korea Spain Taiwan United Kingdom

References

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LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

Reference Type DERIVED
PMID: 39971605 (View on PubMed)

Other Identifiers

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2021-004320-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

77242113PSO2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR109155

Identifier Type: -

Identifier Source: org_study_id

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