Clinical trial NCT06220604: A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)
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: 2024-01-24
Enrollment: 731
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 evaluate 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 at 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 at Weeks 4 and 16
timeFrame: Baseline, Weeks 4 and 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 a >=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 Sign Diary (PSSD) Symptoms 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, Weeks 4 and 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, Weeks 16 and 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, Weeks 16 and 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24
timeFrame: Weeks 16 and 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 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 >=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) Total 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 Week 24
timeFrame: Week 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: Alliance Dermatology and MOHS Center P C
state: Arizona
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Encino
country: United States
facility: T Joseph Raoof Md Inc
state: California
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc
state: California
city: Oceanside
country: United States
facility: Dermatologist Medical Group of North County, Inc.
state: California
city: Miami
country: United States
facility: Miami Dermatology And Laser Institute
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance Inc.
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Douglasville
country: United States
facility: Southeast Dermatology Specialists
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Owensboro
country: United States
facility: Qualmedica Research
state: Kentucky
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Canton
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Kirksville
country: United States
facility: Cleaver Dermatology
state: Missouri
city: Bexley
country: United States
facility: Bexley dermatology research
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc.
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas LLC
state: South Carolina
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
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: Springville
country: United States
facility: Springville Dermatology CCT Research
state: Utah
city: West Valley City
country: United States
facility: Kalo Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Virginia Dermatology Skin Cancer Center Pllc
state: Virginia
city: Benowa
country: Australia
facility: The Skin Centre
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Kogarah
country: Australia
facility: Premier Specialists
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Mitcham
country: Australia
facility: ISHI dermatology
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
city: Brasilia
country: Brazil
facility: Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: Santo Andre
country: Brazil
facility: Fundacao do ABC Centro Universitario FMABC
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: Surrey
country: Canada
facility: Dr. Chih ho Hong Medical
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: London
country: Canada
facility: Lovegrove Dermatology
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre De Recherche Dermatologique Du Quebec Metropolitain
city: Augsburg
country: Germany
facility: Hautarztpraxis Dr. Mihaescu
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
city: Bochum
country: Germany
facility: Niesmann & Othlinghaus GbR
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH - Hautklinik
city: Dresden
country: Germany
facility: Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
city: Dulmen
country: Germany
facility: Hautzentrum Dulmen
city: Dusseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen GmbH
city: Hamburg
country: Germany
facility: Eurofins bioskin GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Mahlow
country: Germany
facility: Hautarztpraxis
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Merzig
country: Germany
facility: Hautmedizin Saar
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Witten
country: Germany
facility: Hautarztpraxis
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
city: Budapest
country: Hungary
facility: Uno Medical Trials Ltd.
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Kft
city: Kecskemet
country: Hungary
facility: Bacs Kiskun Varmegyei Oktatokorhaz
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Kft
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon si
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St Mary s Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun university hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Bialystok
country: Poland
facility: Renew Clinic
city: Katowice
country: Poland
facility: Care Clinic
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Kielce
country: Poland
facility: Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
city: Krakow
country: Poland
facility: SGD s.c.
city: Krakow
country: Poland
facility: Krakowskie Centrum Badan Klinicznych
city: Krakow
country: Poland
facility: Jagiellonskie Centrum Innowacji
city: Krakow
country: Poland
facility: Diamond Clinic
city: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: WroMedica I Bielicka A Strzalkowska s c
city: Cluj-Napoca
country: Romania
facility: Cabinet Medical Dermato-Venerologie
city: Craiova
country: Romania
facility: Centrul Medical Vitaplus
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean de Urgenta
city: Iasi
country: Romania
facility: Sc Iasiprest Srl
city: Oradea
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Bihor
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Timisoara
country: Romania
facility: New Derm Clinic
city: Alcorcon
country: Spain
facility: Hosp. Univ. Fundacion Alcorcon
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Manises
country: Spain
facility: Hosp. de Manises
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias
city: Santiago de 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: Villajoyosa
country: Spain
facility: Hosp. de La Marina Baixa
city: Zaragoza
country: Spain
facility: Hosp. Clinico Univ. Lozano Blesa
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinicaltrial
role: STUDY_DIRECTOR
References: