Clinical trial NCT06143878: A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib 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: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks 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, erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention
* Major surgical procedure, (for example, requiring general anesthesia) 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

Primary outcomes:
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline to Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to Weeks 4 and 16
timeFrame: Baseline, Week 4, and Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 90 Response at Week 8
timeFrame: Baseline and Week 8
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement From Baseline at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16
timeFrame: Weeks 8 and 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16
timeFrame: Baseline, Week 4, and Week 16
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 and 24
timeFrame: Baseline, Week 16, and Week 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24
timeFrame: Weeks 16 and 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24
timeFrame: Baseline, Week 16 and Week 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24
timeFrame: Baseline, Week 16, and Week 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24
timeFrame: Baseline, Week 16, and Week 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants With PSSD Symptom Score of 0 at Week 16
timeFrame: Week 16
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 165 weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 165 weeks
measure: Change From Baseline in Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PASI Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Percent Improvement in PASI Score From Baseline at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline to Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline to Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Symptom Score at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Sign Score at Week 16
timeFrame: Baseline and Week 16
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: Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: JNJ-77242113 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Placebo Group: Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
timeFrame: Baseline and Week 16
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24
timeFrame: Weeks 16 and 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PSSD Symptom Score of 0 at Weeks 16 and 24
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieve PASI 75 Response After Week 24 Among PASI 75 Non-responders to Deucravacitinib at Week 24
timeFrame: Baseline and from Week 24 through Week 156
measure: Percentage of Participants Who Achieve PASI 90 Response After Week 24 Among PASI 90 Non-responders to Deucravacitinib at Week 24
timeFrame: Baseline and from Week 24 through Week 156
measure: Percentage of Participants Achieving IGA Score of 0 or 1 after Week 24, Among Participants with IGA score >=2 at Week 24 in the Deucravacitinib Group
timeFrame: From Week 24 through Week 156
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
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: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: North Miami Beach
country: United States
facility: Ziaderm Research LLC
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: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Skokie
country: United States
facility: Northshore Medical Group
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group LLC
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Lake Charles
country: United States
facility: Dermatology and Advanced Aesthetics
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson MD, Dermatology
state: Michigan
city: Clarkston
country: United States
facility: Michigan Center of Medical Research
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Fife Dermatology
state: Nevada
city: Portsmouth
country: United States
facility: Allcutis Research
state: New Hampshire
city: East Windsor
country: United States
facility: Schweiger Dermatology Group
state: New Jersey
city: Hackensack
country: United States
facility: Schweiger Dermatology Group
state: New Jersey
city: Stony Brook
country: United States
facility: Derm Research Center of New York, Inc.
state: New York
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Athens
country: United States
facility: Oakview Dermatology
state: Ohio
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
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: Richmond
country: United States
facility: National Clinical Research
state: Virginia
city: Mill Creek
country: United States
facility: Frontier Derm Partners CRO, LLC
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto Medico De Alta Complejidad (IMAC)
city: Buenos Aires
country: Argentina
facility: ARCIS Salud SRL Aprillus asistencia e investigacion
city: Caba
country: Argentina
facility: Halitus Instituto Medico S.A. - Dermatologia y Estetica
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Caba
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Rosario
country: Argentina
facility: Instituto Caici Srl.
city: San Miguel De Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists
city: Canberra
country: Australia
facility: Paratus Clinical Research Woden
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
city: Melbourne
country: Australia
facility: Skin Health Institute Inc.
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Santo Andre
country: Brazil
facility: Fundacao do ABC Centro Universitario FMABC
city: Surrey
country: Canada
facility: Enverus Medical
state: British Columbia
city: St. John's
country: Canada
facility: Karma Clinical Trials Inc.
state: Newfoundland and Labrador
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bramsche
country: Germany
facility: Hautarztpraxis
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Dresden
country: Germany
facility: Praxis für Dermatologie und Venerologie
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein Campus Kiel
city: Langenau
country: Germany
facility: Studienzentrum Dr Schwarz Germany
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AOR
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein Campus Lubeck
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Munchen
country: Germany
facility: Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
city: Potsdam
country: Germany
facility: Hautarztpraxis
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock
city: Borgyogyaszati Klinika
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Debrecen
country: Hungary
facility: Derma-B Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kaposvar
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Szeged
country: Hungary
facility: SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft.
city: Veszprem
country: Hungary
facility: Medmare Egeszsegugyi Es Szolgaltato Bt.
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukutsu
country: Japan
facility: Hino Dermatology Clinic
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Ginowan
country: Japan
facility: University of the Ryukyus Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Hokkaido
country: Japan
facility: JR Sapporo Hospital
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Kawasaki City
country: Japan
facility: St Marianna University Hospital
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Obihiro shi
country: Japan
facility: Takagi Dermatological Clinic
city: Osaka Sayama shi
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
city: Sakai-shi
country: Japan
facility: Kume Clinic
city: Sapporo shi
country: Japan
facility: Sapporo Skin Clinic
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Suita City
country: Japan
facility: The University of Osaka Hospital
city: Tachikawa
country: Japan
facility: Jitaikai Tachikawa dermatology clinic
city: Takaoka shi
country: Japan
facility: Shirasaki Dermatology Clinic
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Bialystok
country: Poland
facility: Specderm Poznanska sp j
city: Bialystok
country: Poland
facility: Osteo-Medic s.c A. Racewicz, J Supronik
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
city: Krakow
country: Poland
facility: Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
city: Krakow
country: Poland
facility: Centrum Medyczne dr Rajzer Sp z o o
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp z o o
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Osielsko
country: Poland
facility: Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne
city: Poznan
country: Poland
facility: Clinical Research Center sp z o o MEDIC R s k
city: Warszawa
country: Poland
facility: Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Wroclaw
country: Poland
facility: DERMMEDICA Sp.z o.o.
city: Wroclaw
country: Poland
facility: Wro Medica
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. Dr. Balmis
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: L'Hospitalet de Llobregat
country: Spain
facility: Hosp. Univ. de Bellvitge
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. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. de La Paz
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Hsin Chu
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Kaohsiung City
country: Taiwan
facility: Chang Kung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
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 NHS Foundation Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinicaltrial
role: STUDY_DIRECTOR
References: