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A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

NCT ID: NCT05223868

Last Updated: 2025-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-03

Study Completion Date

2022-12-15

Brief Summary

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Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 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 psoriatic arthritis (PsA) and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (\<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 3: JNJ-77242113 Dose 3 QD and Placebo

Participants will receive JNJ-77242113 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Placebo

Intervention Type DRUG

Placebo tablet will be administered orally.

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

Participants will receive JNJ-77242113 Dose 1 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Placebo

Intervention Type DRUG

Placebo tablet will be administered orally.

Group 2: JNJ-77242113 Dose 2 QD and Placebo

Participants will receive JNJ-77242113 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Placebo

Intervention Type DRUG

Placebo tablet will be administered orally.

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

Participants will receive JNJ-77242113 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Placebo

Intervention Type DRUG

Placebo tablet will be administered orally.

Group 5: JNJ-77242113 Dose 3 BID and Placebo

Participants will receive JNJ-77242113 Dose 3 BID and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 tablet will be administered orally.

Placebo

Intervention Type DRUG

Placebo tablet will be administered orally.

Group 6: Placebo

Participants will receive placebo BID from Week 0 through Week 16.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet will be administered orally.

Interventions

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JNJ-77242113

JNJ-77242113 tablet will be administered orally.

Intervention Type DRUG

Placebo

Placebo tablet will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention
* Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis
* Participant has a total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
* Participant has a total Psoriasis area and severity index (PASI) \>=12 at screening and baseline
* Participant has a total Investigator global assessment (IGA) \>=3 at screening and baseline

Exclusion Criteria

* Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
* Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab)
* Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor \[TNF\]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
* Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention
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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Medical Dermatology Specialists

Phoenix, Arizona, United States

Site Status

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

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, United States

Site Status

Indiana Clinical Trial Center

Plainfield, Indiana, United States

Site Status

DermAssociates, PC

Rockville, Maryland, 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

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

Virginia Clinical Research

Norfolk, Virginia, United States

Site Status

Dermatology Associates

Seattle, Washington, 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

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

Charite - Universitaetsmedizin Berlin (CCM)

Berlin, , Germany

Site Status

Rothhaar Studien GmbH

Berlin, , Germany

Site Status

ISA - Interdisciplinary Study Association 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

Universitatsklinikum Leipzig AOR

Leipzig, , Germany

Site Status

Dermatologische Gemeinschaftspraxis

Mahlow, , Germany

Site Status

Hautarztpraxis

Witten, , Germany

Site Status

Yamanashi Prefectural Central Hospital

Kofu, , Japan

Site Status

Miyata Dermatology Clinic

Matsudo, , Japan

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

Kumamoto Kenhoku Hospital

Tamana, , 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. Provincial de Pontevedra

Pontevedra, , 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, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, , Taiwan

Site Status

Castle Hill Hospital

Cottingham, , United Kingdom

Site Status

Russell's Hall Hospital

Dudley, , United Kingdom

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

Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital

Wakefield, , United Kingdom

Site Status

Countries

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

References

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Strawn D, Krueger JG, Bissonnette R, Eyerich K, Ferris LK, Paller AS, Pinter A, Richards D, Chen EY, Paget K, Horowitz D, Parast R, Rusbuldt JJ, Sendecki J, Bhagat S, Tomsho LP, Chou CH, Polak ME, Keyes BE, Bozenhardt E, Xiong Y, Zhou W, DeKlotz C, Newbold P, Waterworth DM, Miller M, Ota T, Yang YW, Leung MW, Miller LS, Cuff CA, McRae B, Ruane D, Kannan AK. Icotrokinra induces early and sustained pharmacodynamic responses in phase IIb study of patients with moderate-to-severe psoriasis. JCI Insight. 2025 Dec 22;10(24):e193563. doi: 10.1172/jci.insight.193563. eCollection 2025 Dec 22.

Reference Type DERIVED
PMID: 41424381 (View on PubMed)

Bissonnette R, Pinter A, Ferris LK, Gerdes S, Rich P, Vender R, Miller M, Shen YK, Kannan A, Li S, DeKlotz C, Papp K. An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis. N Engl J Med. 2024 Feb 8;390(6):510-521. doi: 10.1056/NEJMoa2308713.

Reference Type DERIVED
PMID: 38324484 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2021-003700-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

77242113PSO2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109138

Identifier Type: -

Identifier Source: org_study_id