Clinical trial NCT06095102: A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
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 Plaque Psoriasis Involving Special Areas
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: 311
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 the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).


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
* Candidate for phototherapy or systemic treatment for plaque psoriasis
* Need to meet criteria: Total body surface area (BSA) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score \>=3 at screening and baseline
* Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
* Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline

Exclusion Criteria:

* Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
* Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA \>=3 at baseline)
* Current drug-induced psoriasis (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

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 at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving Psoriasis Scalp Severity Index (PSSI) 90 at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Week 16
timeFrame: Baseline and 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 >=4-Point Improvement From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving >=4-Point Improvement From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Genital Itch NRS Score at Week 16
timeFrame: Baseline and 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: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving PASI 75 Response 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: Change From Baseline in BSA at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Modified Nail Psoriasis Areas and Severity Index (mNAPSI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving an IGA Score of 0 at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving PSSD Symptom Score of 0 at Week 8
timeFrame: Week 8
measure: Change From Baseline in PSSD Symptom Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in PSSD Sign Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving PSSD Sign Score of 0 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: 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 Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-25 (PROMIS-25) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Palmoplantar Quality of Life Instrument (ppQLI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
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: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research LLC
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
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: Lake Charles
country: United States
facility: Dermatology and Advanced Aesthetics
state: Louisiana
city: Beverly
country: United States
facility: Allcutis Research
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists
state: Nebraska
city: East Windsor
country: United States
facility: Schweiger Dermatology Group
state: New Jersey
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
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: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - Ogden Clinic
state: Utah
city: Mill Creek
country: United States
facility: Frontier Derm Partners CRO, LLC
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: Caba
country: Argentina
facility: Conexa Investigacion Clinica S.A.
city: Caba
country: Argentina
facility: CEDIC Centro de Investigacion clinica
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: Quebec
country: Canada
facility: Centre De Recherche Dermatologique Du Quebec Metropolitain
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
city: Bochum
country: Germany
facility: Niesmann & Othlinghaus GbR
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Dresden
country: Germany
facility: Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg Gmbh
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Witten
country: Germany
facility: Hautarztpraxis
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: 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: 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 Teugbyeolsi
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University 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: 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: 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: Wro Medica
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Esplugues de Llobregat
country: Spain
facility: Hosp. Sant Joan de Deu
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Manises
country: Spain
facility: Hosp. de Manises
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
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
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
city: Harrow
country: United Kingdom
facility: London North West University Healthcare NHS Trust
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 Clinical trial
role: STUDY_DIRECTOR
References: