A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD)

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

The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.

Study Overview

• Status: Active, not recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: JNJ-77242113

• Study Type: Interventional
• Enrollment (Actual): 684
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1417EYG
    • Centro Privado de Medicina Familiar
  • Buenos Aires, Argentina, C1027AAP
    • CINME Metabolic Research Center
  • Caba, Argentina, C1425DKG
    • Psoriahue
  • Ciudad Autonoma de Buenos Aires, Argentina, C1406AGA
    • ARCIS Salud SRL Aprillus asistencia e investigacion
  • Mar Del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Médicas Mar del Plata
  • Rosario, Argentina, S2000DBS
    • Instituto De Especialidades De La Salud SRL
  • San Fernando Buenos Aires, Argentina, B1646
    • MR Medicina Reumatologica
• Australia
  • East Melbourne, Australia, 3002
    • Dr Rodney Sinclair Pty Ltd
  • Melbourne, Australia, 3004
    • The Alfred Hospital
  • Miranda, Australia, 2228
    • Kingsway Dermatology & Aesthetics
  • Mitcham, Australia, 3132
    • ISHI dermatology
  • Parkville, Australia, 3050
    • Royal Melbourne Hospital
  • Woolloongabba, Australia, 4102
    • Veracity Clinical Research
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc.
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Dermatology Clinic Edmonton Downtown
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dr Wei Jing Loo Medicine Professional Corporation
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research Inc.
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. Sk Siddha Medicine Professional Corporation
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Center
    • Toronto, Ontario, Canada, M4C 1L1
      • FACET Dermatology
    • Windsor, Ontario, Canada, N8T 1E6
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital Capital Medical University
  • Beijing, China, 100013
    • China-Japan Friendship Hospital
  • Bengbu, China, 233099
    • The Affiliated Hospital of Bengbu Medical College
  • Cheng De Shi, China, 067030
    • Hosp. of Chengde Medical University
  • Chengdu, China, 610017
    • Chengdu Second People's Hospital
  • Jiaxing, China, 314001
    • The First hospital of Jiaxing
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University
  • Nan Yang Shi, China, 473004
    • NanYang First people's hospital
  • NanChang, China, 330000
    • Dermatology Hospital of Jiangxi Province
  • Shanghai, China, 200443
    • Shanghai Skin Disease Hospital
  • Shen Yang, China, 110016
    • Northeast International Hospital
  • Wuhan, China, 430022
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xi'an, China, 710004
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Zhenjiang, China, 212001
    • Affiliated Hospital of Jiangsu University
• France
  • Antony, France, 92160
    • Hopital Prive d'Antony
  • Argenteuil, France, 95107
    • Centre Hospitalier Victor Dupouy
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10117
    • Charite - Campus Mitte
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden GmbH
  • Dulmen, Germany, 48249
    • Hautzentrum Dulmen
  • Dusseldorf, Germany, 40212
    • Privatpraxis Dr. Hilton & Partner
  • Frankfurt am Main, Germany, 60590
    • Universitaetsklinikum Frankfurt
  • Freiburg, Germany, 79104
    • Universitaetsklinikum Freiburg
  • Friedrichshafen, Germany, 88045
    • Derma-Study-Center Friedrichshafen GmbH
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Mahlow, Germany, 15831
    • Hautarztpraxis
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg
  • Remscheid, Germany, 42897
    • Hautarztpraxis Mortazawi
  • Tubingen, Germany, 72076
    • Universitaetsklinik Tuebingen
  • Witten, Germany, 58453
    • Hautarztpraxis
  • Wuppertal, Germany, 42287
    • CentroDerm GmbH
• Hungary
  • Borgyogyaszati Klinika, Hungary, 7632
    • Pécsi Tudományegyetem
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4031
    • Derma-B Kft
  • Kaposvar, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Szeged, Hungary, 6720
    • SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft.
  • Veszprem, Hungary, 8200
    • Medmare Egeszsegugyi Es Szolgaltato Bt.
• Italy
  • Palermo, Italy, 90127
    • Azienda Di Rilievo Nazionale E Di Alta Specializzazione
  • Parma, Italy, 43126
    • Azienda Ospedaliero Universitaria di Parma
  • Roma, Italy, 00133
    • Policlinico Tor Vergata
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• Japan
  • Itabashi Ku, Japan, 173 8606
    • Teikyo University Hospital
  • Kitakyushu-shi, Japan, 807-8556
    • Hospital of the University of Occupational and Environmental Health
  • Mito, Japan, 310 0015
    • Mito Kyodo General Hospital
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Osaka Sayama shi, Japan, 589 8511
    • Kindai University Hospital
  • Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Shinjuku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tsu, Japan, 514 8507
    • Mie University Hospital
• Korea, Republic of
  • Ansan-si, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Gwangju, Korea, Republic of, 61453
    • Chosun University Hospital
  • Gyeonggi-do, Korea, Republic of, 14068
    • Hallym University Sacred Heart Hospital
  • Gyeonggi-do, Korea, Republic of, 13496
    • CHA Bundang Medical Center, CHA University
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
• Poland
  • Bialystok, Poland, 15 375
    • Specderm Poznanska sp j
  • Bialystok, Poland, 15-351
    • Osteo-Medic s.c A. Racewicz, J Supronik
  • Elblag, Poland, 82-300
    • Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
  • Krakow, Poland, 31-411
    • Centrum Medyczne PROMED
  • Krakow, Poland, 30 002
    • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
  • Krakow, Poland, 30-438
    • Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  • Lodz, Poland, 90 265
    • Dermed Centrum Medyczne Sp z o o
  • Osielsko, Poland, 86031
    • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
  • Poznan, Poland, 60-529
    • Solumed Centrum Medyczne
  • Poznan, Poland, 61 731
    • Clinical Research Center sp z o o MEDIC R s k
  • Warszawa, Poland, 02-953
    • Klinika Ambroziak Dermatologia
  • Warszawa, Poland, 01-817
    • Przychodnia Specjalistyczna High Med
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 51 503
    • DERMMEDICA Sp.z o.o.
  • Wrocław, Poland, 51-685
    • WroMedica I.Bielicka, A.Strzałkowska s.c.
• Spain
  • Alcorcon, Spain, 28922
    • Hosp. Univ. Fundacion Alcorcon
  • Alicante, Spain, 03010
    • Hosp. Gral. Univ. Dr. Balmis
  • Barcelona, Spain, 08041
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Bilbao, Spain, 48013
    • Hosp. Univ. de Basurto
  • Madrid, Spain, 28007
    • Hosp. Gral. Univ. Gregorio Maranon
  • Madrid, Spain, 28006
    • Grupo Dermatologico Y Estetico Pedro Jaen
  • Palma de Mallorca, Spain, 07120
    • Hosp. Univ. Son Espases
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Sevilla, Spain, 41009
    • Hosp. Virgen Macarena
  • Valencia, Spain, 46940
    • Hosp. de Manises
• Taiwan
  • Hsin Chu, Taiwan, 30059
    • National Taiwan University Hospital Hsin-Chu Branch
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33382
    • Linkou Chang Gung Memorial Hospital
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe University Medical Faculty
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty
  • Kayseri, Turkey, 38039
    • Erciyes University Medical Faculty
  • Samsun, Turkey, 55270
    • Ondokuz Mayis University
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • London North West University Healthcare NHS Trust
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • San Diego, California, United States, 92123
      • Rady Childrens Hospital San Diego
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Miami, Florida, United States, 33155
      • Bioclinical Research Alliance Inc.
    • North Miami Beach, Florida, United States, 33162
      • Ziaderm Research, LLC
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research Inc
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077
      • Northshore Medical Group
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trial Center
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Dermatology and Advanced Aesthetics
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Michigan Center of Medical Research
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Windsor Dermatology
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Athens, Ohio, United States, 45701
      • Oakview Dermatology
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians Health Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • Central Sooner Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • The Pennsylvania Centre for Dermatology, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Bellaire, Texas, United States, 77401
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Utah
    • Springville, Utah, United States, 84663
      • Springville Dermatology CCT Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology Skin Cancer Center Pllc
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Derm Partners CRO, LLC
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-77242113; Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have >=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.
Experimental: Placebo; Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.	Drug: Placebo; Placebo will be administered orally; Drug: JNJ-77242113; JNJ-77242113 will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Percentage of participants who achieve an IGA score of 0 or 1 and >=2-grade improvement from baseline to Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Baseline to Week 16
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16	Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an IGA Score of 0 at Week 16	Percentage of participants who achieve an IGA score of 0 at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16	Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 4 and 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Weeks 4 and 16
Percentage of Participants Achieving PASI 90 Response at Week 8	Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 8 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Week 8
Percentage of Participants Achieving PASI 100 Response at Week 16	Percentage of participants achieving PASI 100 response (>=100% improvement in PASI) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement Baseline to Week 16	Percentage of participants achieving ss-IGA score of 0 or 1 and >=2 grade improvement baseline to Week 16 will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).	Baseline to Week 16
Percentage of Participants Achieving Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16	Percentage of participants achieving PSSD symptom score of 0 at Weeks 8 and 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Weeks 8 and 16
Percentage of Participants Achieving >=4-Point Improvement From Baseline in PSSD Itch Score to Weeks 4 and 16	Percentage of participants achieving >=4-Point improvement from baseline in PSSD itch score to Weeks 4 and 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Baseline to Weeks 4 and 16
Time to Loss of PASI 75	Time to loss of PASI 75 will be reported. Loss of PASI 75 response is defined as <75% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=75% improvement in PASI from baseline at Week 24. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 75 response represents at least a 75% improvement from baseline in the PASI score.	Week 24 up to Week 52
Number of Participants with Treatment-emergent Adverse Events (AEs)	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to 160 weeks
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)	A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.	Up to 160 weeks
Change from Baseline in Body Surface Area (BSA) at Week 16	Change from baseline in BSA to Week 16 will be reported. BSA is a commonly used measure of extent of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed (that is, plaque psoriasis).	Baseline to Week 16
Change from Baseline in PASI Total Score to Week 16	Change from baseline in PASI total score to Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Week 16
Percent Improvement in PASI Score From Baseline to Week 16	Percent improvement in PASI score from baseline to Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Week 16
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	Percentage of participants achieving a sPGA-G Score of 0 or 1 and at Least a 2-grade Improvement in genital psoriasis from baseline to Week 16 will be reported. The sPGA-G is a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).	Baseline to Week 16
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	Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement at Week 16 will be reported. The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3), and severe (4).	Week 16
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16	Percent change from baseline in mNAPSI score at Week 16 will be reported. The mNAPSI is an index used for assessing and grading the severity of nail psoriasis. Each of the participant's 10 fingernails are evaluated for 7 features. The first3 features are each scored from 0 to 3 in severity and are (1) onycholysis and oil-drop dyschromia, (2) pitting, and (3) nail plate crumbling. The next 4 features are scored 0 - absent or 1 - present and are (1) leukonychia, (2) splinter hemorrhages, (3) nail bed hyperkeratosis, and (4) red spots in the lunula. The score ranges from 0 to 13 per nail and 0 to 130 for all fingernails.	Baseline to Week 16
Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16	Percent of participants achieving f-PGA score of 0 or 1 at Week 16 will be reported. The f-PGA is used to evaluate the current status of a participant's fingernail psoriasis on a scale of 0 to 4 (clear [0], minimal [1], mild [2], moderate [3], or severe [4]).	At Week 16
Change From Baseline in PSSD Symptom Score to Week 16	Change from baseline in PSSD symptom score to Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Baseline to Week 16
Change From Baseline in PSSD Sign Score to Week 16	Change from baseline in PSSD sign score to Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Baseline to Week 16
Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16	Percentage of participants achieving PSSD sign score of 0 at Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Week 16
Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16	Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 will be reported. The GenPs-SFQ is a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (never [0], rarely [1], sometimes [2], often [3], or always [4]).	Week 16
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16	Percentage of participants achieving DLQI score of 0 or 1 at Week 16 will be reported. The DLQI is a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.	Week 16
Change From Baseline in Total DLQI Score at Week 16	Change from baseline in total DLQI score at Week 16 will be reported. The DLQI is a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL.	Baseline to Week 16
Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16	Change from baseline in domain scores of the PROMIS-29 score at Week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL survey, assessing each of the 7 PROMIS domains(depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. The questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes.	Baseline to Week 16
Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16	Percentage of participants achieving CDLQI score of 0 or 1 at Week 16 will be reported. The CDLQI is an adapted version of the DLQI for the pediatric population and will be utilized in the adolescent population in this study. The adaption and validation of the CDLQI was undertaken by the original developer of the DLQI to ensure it addressed the specific needs of the pediatric population. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Higher scores indicate greater impact on HRQoL. The instrument is designed for use in children is self-explanatory and can be simply handed to the participant who is asked to fill it in with the help of the child's parent or caregiver.	Week 16
Change From Baseline in CDLQI at Week 16	Change from baseline in CDLQI at Week 16 will be reported. The CDLQI is an adapted version of the DLQI for the pediatric population and will be utilized in the adolescent population in this study. The adaption and validation of the CDLQI was undertaken by the original developer of the DLQI to ensure it addressed the specific needs of the pediatric population. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Higher scores indicate greater impact on HRQoL. The instrument is designed for use in children is self-explanatory and can be simply handed to the participant who is asked to fill it in with the help of the child's parent or caregiver.	Baseline to Week 16
Change From Baseline in the Domain Scores of the PROMIS-25 Pediatric Score at Week 16	Change from baseline in the domain scores of the PROMIS-25 pediatric score at Week 16 will be reported. The PROMIS-25 will be utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. There is also one 11-point rating scale for pain intensity. The instrument is designed for use in ages 8-17 years of age and can be self-administered.	Baseline to Week 16
Percentage of Participants Achieving IGA Score of 0 at Week 52	Percentage of participants achieving IGA score of 0 at Week 52 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 52
Time to Loss of IGA 0 to 1 Response	Time to loss of IGA 0 to 1 response will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 24 to Week 52
Percentage of Adolescent Participants Achieving IGA Score of 0 or 1 and >=2 Improvement From Baseline to Week 52	Percentage of adolescent participants achieving IGA score of 0 or 1 and IGA score >=2 from baseline to Week 52 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Baseline to Week 52
Percentage of Adolescent Participants Achieving PASI 75 Response at Week 52	Percentage of adolescent participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Week 52 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Week 52
Percentage of Adolescent Participants Achieving PASI 90 Response at Week 52	Percentage of adolescent participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 52 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline to Week 52
Time to Loss of PASI 90	Time to loss of PASI 90 will be reported. Loss of PASI 90 response is defined as <90% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=90% improvement in PASI from baseline at Week 24. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.	Week 24 up to Week 52
Percentage of Participants Achieving PASI 100 Response at Week 52	Percentage of participants achieving PASI 100 response (100% improvement in PASI) at Week 52 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 52

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): November 19, 2024
• Study Completion (Estimated): April 6, 2027

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 77242113PSO3001 (Other Identifier: Janssen Research & Development, LLC); 2023-505120-59-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No