Clinical trial NCT06095115: A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Retreatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 684
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 purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis, 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
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

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 or its excipients
* Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study

Primary outcomes:
measure: 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 to Week 16
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving an IGA Score of 0 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16
timeFrame: Baseline to Weeks 4 and 16
measure: Percentage of Participants Achieving PASI 90 Response at Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Participants Achieving PASI 100 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16
timeFrame: Weeks 8 and 16
measure: Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score to Weeks 4 and 16
timeFrame: Baseline to Weeks 4 and 16
measure: Time to Loss of PASI 75
timeFrame: Week 24 up to Week 52
measure: Time to Loss of PASI 90
timeFrame: Week 24 up to Week 52
measure: Number of Participants with Treatment-emergent Adverse Events (AEs)
timeFrame: Up to 160 weeks
measure: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to 160 weeks
measure: Change from Baseline in Body Surface Area (BSA) at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in PASI Total Score to Week 16
timeFrame: Baseline to Week 16
measure: Percent Improvement in PASI Score From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: 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 in Genital Psoriasis From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: 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 at Week 16
timeFrame: Week 16
measure: Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16
timeFrame: Baseline to Week 16
measure: Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16
timeFrame: At Week 16
measure: Change From Baseline in PSSD Symptom Score to Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in PSSD Sign Score to Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16
timeFrame: Week 16
measure: 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: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Change From Baseline in Total DLQI Score at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Change From Baseline in CDLQI at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in the Domain Scores of the PROMIS-25 Pediatric Score at Week 16
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving IGA Score of 0 at Week 52
timeFrame: Week 52
measure: Percentage of Participants Achieving PASI 100 Response at Week 52
timeFrame: Week 52
measure: Time to Loss of IGA 0 to 1 Response
timeFrame: Week 24 to Week 52
measure: Percentage of Adolescent Participants Achieving IGA Score of 0 or 1 and >=2 Improvement From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Adolescent Participants Achieving PASI 75 Response at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Adolescent Participants Achieving PASI 90 Response at Week 52
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
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: San Diego
country: United States
facility: Rady Childrens Hospital San Diego
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: Miami
country: United States
facility: Bioclinical Research Alliance Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Ziaderm Research LLC
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
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: Owensboro
country: United States
facility: Qualmedica Research
state: Kentucky
city: Lake Charles
country: United States
facility: Dermatology and Advanced Aesthetics
state: Louisiana
city: Beverly
country: United States
facility: Allcutis Research
state: Massachusetts
city: Clarkston
country: United States
facility: Michigan Center of Medical Research
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists
state: Nebraska
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: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
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: Fairborn
country: United States
facility: Wright State Physicians Health Center
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: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
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: Springville
country: United States
facility: Springville Dermatology CCT Research
state: Utah
city: Norfolk
country: United States
facility: Virginia Dermatology Skin Cancer Center Pllc
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: CINME Metabolic Research Center
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: Caba
country: Argentina
facility: Psoriahue
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: ARCIS Salud SRL Aprillus asistencia e investigacion
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Instituto De Especialidades De La Salud SRL
city: San Fernando
country: Argentina
facility: MR Medicina Reumatologica
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Miranda
country: Australia
facility: Kingsway Dermatology & Aesthetics
city: Mitcham
country: Australia
facility: ISHI dermatology
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology Clinic Edmonton Downtown
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih ho Hong Medical
state: British Columbia
city: London
country: Canada
facility: Mediprobe Research Inc.
state: Ontario
city: London
country: Canada
facility: Dr Wei Jing Loo Medicine Professional Corporation
state: Ontario
city: Newmarket
country: Canada
facility: Dr. Sk Siddha Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Canadian Dermatology Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Beijing
country: China
facility: China Japan Friendship Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Bengbu
country: China
facility: The Affiliated Hospital of Bengbu Medical College
city: Cheng De Shi
country: China
facility: Hosp. of Chengde Medical University
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nan Yang Shi
country: China
facility: Nanyang First People's Hospital
city: NanChang
country: China
facility: Dermatology Hospital of Jiangxi Province
city: Shanghai
country: China
facility: Shanghai skin disease hospital
city: Shen Yang
country: China
facility: Northeast International Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
city: Antony
country: France
facility: Hopital Prive d'Antony
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Charite - Campus Mitte
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Dulmen
country: Germany
facility: Hautzentrum Dulmen
city: Dusseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Mahlow
country: Germany
facility: Hautarztpraxis
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Remscheid
country: Germany
facility: Hautarztpraxis Mortazawi
city: Tubingen
country: Germany
facility: Universitaetsklinik Tuebingen
city: Witten
country: Germany
facility: Hautarztpraxis
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
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: Palermo
country: Italy
facility: Azienda Di Rilievo Nazionale E Di Alta Specializzazione
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Mito
country: Japan
facility: Mito Kyodo General Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Osaka Sayama shi
country: Japan
facility: Kindai University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun university hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
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: Alcorcon
country: Spain
facility: Hosp. Univ. Fundacion Alcorcon
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. Dr. Balmis
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Madrid
country: Spain
facility: Grupo Dermatologico Y Estetico Pedro Jaen
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Valencia
country: Spain
facility: Hosp. de Manises
city: Hsin Chu
country: Taiwan
facility: National Taiwan University Hospital Hsin Chu Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS 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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: