Clinical trial NCT06934226: A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2025-04-18
Enrollment: 675
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
* Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
* Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
* Total investigator global assessment (IGA) \>=3 at screening and baseline
* Candidate for phototherapy or systemic treatment for plaque psoriasis

Exclusion Criteria:

* Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
* Major surgical procedure within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
* Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)

Primary outcomes:
measure: JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 16
timeFrame: Week 16
measure: Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 108
measure: JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Sign Score of 0 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
timeFrame: Baseline up to Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Change from Baseline in Body Surface Area (BSA) Score at Week 16
timeFrame: Baseline up to Week 16
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Sign Score at Week 28
timeFrame: Baseline up to Week 28
measure: JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Symptom Score at Week 28
timeFrame: Baseline up to Week 28
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Sign Score of 0 at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Ustekinumab Group: Change from Baseline in DLQI Score at Week 28
timeFrame: Baseline up to Week 28
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 28
timeFrame: Week 28
measure: JNJ-77242113 and Ustekinumab Group: Change from Baseline in BSA Score at Week 16
timeFrame: Baseline up to Week 16
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research Inc
state: Alabama
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research LLC
state: Georgia
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Bowling Green
country: United States
facility: Equity Medical
state: Kentucky
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Kirksville
country: United States
facility: Cleaver Dermatology
state: Missouri
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research Philadelphia
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Nashville
country: United States
facility: Advanced Research Experts PLLC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: West Valley City
country: United States
facility: Kalo Clinical Research
state: Utah
city: Mill Creek
country: United States
facility: Frontier Derm Partners CRO, LLC
state: Washington
city: Buenos Aires
country: Argentina
facility: Mindout Research
city: Buenos Aires
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
city: Caba
country: Argentina
facility: Investigaciones Medicas IMOBA SRL
city: Caba
country: Argentina
facility: CIPREC
city: Caba
country: Argentina
facility: Halitus Instituto Medico S.A. - Dermatologia y Estetica
city: Caba
country: Argentina
facility: Mautalen Salud e Investigacion
city: Rosario
country: Argentina
facility: Instituto De Especialidades De La Salud SRL
city: Tucuman
country: Argentina
facility: Instituto de Investigaciones Medicas Tucuman
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
city: Kogarah
country: Australia
facility: Premier Specialists
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Mitcham
country: Australia
facility: ISHI dermatology
city: Gent
country: Belgium
facility: AZ St. Lucas
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: The Centre de recherche Saint-Louis
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Sjællands University hospital
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bramsche
country: Germany
facility: Studienzentrum an der Hase GbR
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein Campus Kiel
city: Langenau
country: Germany
facility: Studienzentrum Dr Schwarz Germany
city: Mahlow
country: Germany
facility: Dermatologie Mahlow
city: Mainz
country: Germany
facility: Gemeinschaftspraxis Dres. Quist
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Witten
country: Germany
facility: Hautarztpraxis
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Uno Medical Trials Ltd.
city: Debrecen
country: Hungary
facility: Derma-B Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyongyos
country: Hungary
facility: Gyongyosi Bugat Pal Korhaz
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Kft
city: Hodmezovasarhely
country: Hungary
facility: Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
city: Kaposvar
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Kecskemet
country: Hungary
facility: Bacs-kiskun Megyei Korhaz
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft.
city: Veszprem
country: Hungary
facility: Medmare Egeszsegugyi Es Szolgaltato Bt.
city: Bialystok
country: Poland
facility: Osteo-Medic s.c A. Racewicz, J Supronik
city: Bialystok
country: Poland
facility: Specderm Poznanska sp j
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
city: Katowice
country: Poland
facility: Care Clinic Sp z o o
city: Krakow
country: Poland
facility: Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp z o o
city: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne
city: Warszawa
country: Poland
facility: Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Wroclaw
country: Poland
facility: WroMedica
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Braga
country: Portugal
facility: Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
city: Leiria
country: Portugal
facility: Unidade Local De Saude Da Regiao De Leiria Epe
city: Lisboa
country: Portugal
facility: Hosp. Cuf Descobertas
city: Porto
country: Portugal
facility: Ulssa Hosp. Santo Antonio
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. Dr. Balmis
city: Barcelona
country: Spain
facility: Hosp. Clinic de Barcelona
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Madrid
country: Spain
facility: Grupo Dermatologico Y Estetico Pedro Jaen
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Manises
country: Spain
facility: Hosp. de Manises
city: Santiago Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Ntra. Sra. de Valme
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Villajoyosa
country: Spain
facility: Hosp. de La Marina Baixa
city: Zaragoza
country: Spain
facility: Hosp. Clinico Univ. Lozano Blesa
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: Kings Lynn
country: United Kingdom
facility: The Queen Elizabeth Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire NHS Trust
Study officials:
References: