A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

NCT ID: NCT05357755

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2023-04-10

Brief Summary

The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

Detailed Description

The population of people living with moderate to severe psoriasis is approximately 3.5 billion who 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 and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75 (greater than or equal to [>=] 75 percentage [%] improvement in PASI) (PASI 75) response at Week 16. 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 placebo- controlled treatment period, and a follow-up visit approximately 4 weeks after the last administration of study intervention. Safety assessments include adverse events (AEs) monitoring, clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, concomitant medication monitoring, pregnancy testing, Columbia Suicide Severity Rating Scale (C-SSRS) and tuberculosis evaluations.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: JNJ-77242113 Dose 1

Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered orally as delayed release tablets.

Group 2: JNJ-77242113 Dose 2

Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.

Group Type: EXPERIMENTAL

JNJ-77242113

Intervention Type: DRUG

JNJ-77242113 will be administered orally as delayed release tablets.

Group 3: Placebo

Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be administered orally as delayed release tablets.

Interventions

JNJ-77242113

JNJ-77242113 will be administered orally as delayed release tablets.

Intervention Type: DRUG

Placebo

Matching placebo will be administered orally as delayed release tablets.

Intervention Type: DRUG

Other Intervention Names

PN-21235,; PN-235

Eligibility Criteria

Inclusion Criteria

• Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
• Participant has a total Body Surface Area (BSA) greater than or equal to (>=) 10 percentage (%) at screening and baseline
• Participant has a total Psoriasis Area and Severity Index (PASI) >= 12 at screening and baseline
• Participant has a total Investigator's Global Assessment (IGA) >= 3 at screening and baseline
• Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis

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 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
• Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
• Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or zegerid) within 1 week of first administration of study intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Stoll Dermatology

Beverly Hills, California, United States

Northshore University Healthsystem

Skokie, Illinois, United States

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States

Dermatology Specialists

Louisville, Kentucky, United States

Lawrence J Green MD LLC

Rockville, Maryland, United States

ActivMed Practices and Research

Beverly, Massachusetts, United States

ActivMed Practices and Research

Portsmouth, New Hampshire, United States

Windsor Dermatology, PC

East Windsor, New Jersey, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, United States

Health Concepts

Rapid City, South Dakota, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Dermatology Research Institute Inc

Calgary, Alberta, Canada

The Guenther Dermatology Research Centre

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

CHRU Brest - Hopital Morvan

Brest, , France

CHU de Grenoble Hopital Albert Michallon

La Tronche, , France

CHU de Nice Hopital de l Archet

Nice, , France

Polyclinique de Courlancy

Reims, , France

Hautarztpraxis

Bramsche, , Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Privatpraxis Dr. Hilton & Partner

Düsseldorf, , Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, , Germany

Universitatsklinikum Munster

Münster, , Germany

Universitaetsmedizin Rostock

Rostock, , Germany

Specderm Poznanska sp j

Bialystok, , Poland

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, , Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, , Poland

Hosp. Univ. de Cruces

Barakaldo, , Spain

Hosp. Univ. San Cecilio

Granada, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Countries

United States; Canada; France; Germany; Poland; Spain

Other Identifiers

2021-005987-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

77242113PSO2003

Identifier Type: OTHER

Identifier Source: secondary_id

CR109193

Identifier Type: -

Identifier Source: org_study_id