A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND)

77242113PSO3006: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ 77242113 for the Treatment of Participants With Moderate to Severe Plaque Ps

The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 752
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Barrio Gral Paz Cba Capital, Argentina, X5000
    • Consultora Integral de Salud SRL
  • Buenos Aires, Argentina, B1643CRO
    • Instituto Medico De Alta Complejidad (IMAC)
  • Buenos Aires, Argentina, C1417EYG
    • Mindout Research
  • Buenos Aires, Argentina, C1425
    • Instituto de Neumonologia y Dermatologia
  • CABA, Argentina, C1061AAS
    • CIPREC
  • CABA, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • CABA, Argentina, C1055AAO
    • Buenos Aires Skin
  • CABA, Argentina, C1056ABH
    • Investigaciones Medicas IMOBA SRL
  • CABA, Argentina, C1128
    • Mautalen Salud e Investigacion
  • Caba, Argentina, C1122AAF
    • Halitus Instituto Medico S.A. - Dermatologia y Estetica
  • Rosario, Argentina, S2000DBS
    • Instituto De Especialidades De La Salud SRL
  • San Fernando, Argentina, B1646
    • MR Medicina Reumatologica
  • San Miguel de Tucumán, Argentina, T4000
    • Instituto de Investigaciones Medicas Tucuman
• Australia
  • Clayton, Australia, 3168
    • Monash Medical Centre
  • Coorparoo, Australia, 4151
    • Cornerstone Dermatology
  • Kogarah, Australia, 2217
    • Premier Specialists
  • Melbourne, Australia, 3004
    • The Alfred Hospital
  • Melbourne, Australia, 3050
    • Royal Melbourne Hospital
  • Mitcham, Australia, 3132
    • ISHI dermatology
  • Westmead, Australia, 2145
    • Westmead Hospital
  • Woolloongabba, Australia, 4102
    • Veracity Clinical Research
• Austria
  • Feldkirch, Austria, 6800
    • LKH Feldkirch
  • Linz, Austria, 4020
    • Kepler Universitatsklinikum GmbH
  • Sankt Pölten, Austria, 3100
    • Universtitatsklinikum St Polten
  • Vienna, Austria, 1090
    • Allgemeines Krankenhaus der Stadt Wien
• Belgium
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Ghent, Belgium, 9000
    • AZ St. Lucas
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Maldegem, Belgium, 9990
    • Dermatologie Maldegem
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
      • Skincare Studio Inc Dermatology Clinical Trials
  • Ontario
    • Ajax, Ontario, Canada, L1S7K8
      • CCA Medical Research Corporation
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Centre
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research
    • London, Ontario, Canada, N6A 5R9
      • Lovegrove Dermatology
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc.
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
    • Québec, Quebec, Canada, G1W 4R4
      • The Centre de recherche Saint-Louis
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg Sygehus Syd
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • København NV, Denmark, 2400
    • Bispebjerg Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Sjællands University hospital
• Germany
  • Augsburg, Germany, 86179
    • Klinikum Augsburg
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn
  • Bramsche, Germany, 49565
    • Studienzentrum an der Hase GbR
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Dresden, Germany, 01307
    • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
  • Friedrichshafen, Germany, 88045
    • Derma-Study-Center Friedrichshafen GmbH
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig Holstein Campus Kiel
  • Langenau, Germany, 89129
    • Studienzentrum Dr Schwarz Germany
  • Mahlow, Germany, 15831
    • Dermatologie Mahlow
  • Mainz, Germany, 55128
    • Gemeinschaftspraxis Dres. Quist
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Witten, Germany, 58453
    • Hautarztpraxis
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Budapest, Hungary, 1152
    • Uno Medical Trials Ltd.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4031
    • Derma-B Kft
  • Gyula, Hungary, 5700
    • Synexus Magyarorszag Kft
  • Gyöngyös, Hungary, 3200
    • Gyongyosi Bugat Pal Korhaz
  • Hódmezővásárhely, Hungary, 6800
    • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
  • Kaposvár, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Kecskemét, Hungary, 6000
    • Bacs-kiskun Megyei Korhaz
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft.
  • Veszprém, Hungary, 8200
    • Medmare Egeszsegugyi Es Szolgaltato Bt.
• 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
  • Katowice, Poland, 40 568
    • Care Clinic Sp z o o
  • Krakow, Poland, 30 002
    • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
  • Lodz, Poland, 90-265
    • Dermed Centrum Medyczne Sp z o o
  • Olsztyn, Poland, 10-117
    • Etyka Osrodek Badan Klinicznych
  • Poznan, Poland, 60 529
    • SOLUMED Centrum Medyczne
  • Skierniewice, Poland, 96 100
    • Velocity Nova Sp z o o
  • Warsaw, Poland, 02 661
    • Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
  • Warsaw, Poland, 02 953
    • Klinika Ambroziak Dermatologia
  • Wroclaw, Poland, 52 416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 51 685
    • WroMedica I Bielicka A Strzalkowska s c
• Portugal
  • Guimarães, Portugal, 4835 044
    • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
  • Leiria, Portugal, 2410 197
    • Unidade Local De Saude Da Regiao De Leiria Epe
  • Lisbon, Portugal, 1169 050
    • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
  • Lisbon, Portugal, 1998 018
    • Hosp. Cuf Descobertas
  • Porto, Portugal, 4099 001
    • Ulssa Hosp. Santo Antonio
• Spain
  • Alicante, Spain, 03010
    • Hosp. Gral. Univ. Dr. Balmis
  • Barakaldo, Spain, 48902
    • Hosp. Univ. de Cruces
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Granada, Spain, 18016
    • Hosp. Univ. San Cecilio
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Madrid, Spain, 28002
    • Grupo Dermatologico Y Estetico Pedro Jaen
  • Manises, Spain, 46940
    • Hosp. de Manises
  • Santiago Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Seville, Spain, 41014
    • Hosp. Ntra. Sra. de Valme
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
  • Villajoyosa, Spain, 03570
    • Hosp. de La Marina Baixa
  • Zaragoza, Spain, 50009
    • Hosp. Clinico Univ. Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hosp. Univ. Miguel Servet
• United Kingdom
  • Dudley, United Kingdom, DY1 2HQ
    • Dudley Group NHS Foundation Trust
  • Harrow, United Kingdom, HA1 3UJ
    • London North West University Healthcare NHS Trust
  • Kings Lynn, United Kingdom, PE30 4ET
    • The Queen Elizabeth Hospital NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
  • Southampton, United Kingdom, So166yd
    • University Hospital Southampton
  • Wakefield, United Kingdom, WF1 4DG
    • Mid Yorkshire Hospital NHS Trust- Pinderfields Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Research Inc
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Encino, California, United States, 91436
      • T Joseph Raoof Md Inc
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Oceanside, California, United States, 92056
      • Dermatologist Medical Group of North County, Inc.
    • Rocklin, California, United States, 95765
      • Norcal Clinical Research
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Education & Research Institute
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Conn Health Center
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Driven Research LLC
    • Miami, Florida, United States, 33155
      • Bioclinical Research Alliance Inc.
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research Inc
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research LLC
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Northshore Medical Group
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trial Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Caledonia, Michigan, United States, 49316
      • The Derm Institute of West Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • Cleaver Dermatology
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group
    • New York, New York, United States, 10028
      • Mount Sinai Doctors Dermatology
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Dermatology Mayfield Heights
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Dermatology
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Advanced Research Experts PLLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Dallas, Texas, United States, 75231
      • Modern Research Associates PLLC
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies 1
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Utah
    • West Valley City, Utah, United States, 84120
      • Kalo Clinical Research
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Derm Partners CRO, LLC

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 (PsA), 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 [e.g.], erythrodermic, guttate, or pustular)
• Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
• Major surgical procedure 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
• Transplanted organ (with exception of a corneal transplant greater than [>] 12 weeks before the first administration of study intervention)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: JNJ 77242113; Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.; Drug: Matching Placebo to Ustekinumab; Matching placebo will be administered subcutaneously.
Placebo Comparator: Arm 2: Placebo; Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.; Drug: Matching Placebo to Ustekinumab; Matching placebo will be administered subcutaneously.; Drug: Matching Placebo to JNJ-77242113; Matching placebo will be administered orally.
Active Comparator: Arm 3: Ustekinumab; Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.; Drug: Matching Placebo to JNJ-77242113; Matching placebo will be administered orally.; Drug: Ustekinumab; Ustekinumab will be administered subcutaneously.; Other Names: STELARA; CNTO 1275

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16	IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants achieving at least a 75 percent improvement from baseline in the PASI score.	Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score.	Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16	IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28	IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 28
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.	Week 28
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 28	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score.	Week 28
JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16	PSSD includes patient-reported outcome (PRO) questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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
JNJ-77242113 and Placebo Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 16	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any untoward medical occurrence that results in: death, is life-threatening, requires in-patient hospitalization/prolongs existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of infectious agent via medicinal product & is medically important.	Up to Week 108
JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Sign Score of 0 at Week 16	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. This PRO includes 11 items in total, with 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). A 0 to 10 numerical rating scale for severity is used to rank the psoriasis sign score. A higher score indicates more severe disease.	Week 16
JNJ-77242113 and Placebo Group: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16	DLQI will be utilized in the adult population and is a dermatology specific health related quality of life (HRQoL) instrument designed to assess the impact of the disease on the HRQoL It is a 10-item questionnaire that 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 up to Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 16	DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL It is a 10 item questionnaire that 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
JNJ-77242113 and Placebo Group: Change from Baseline in Body Surface Area (BSA) Score at Week 16	BSA is a commonly used measure of involvement 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). The handprint method for assessing BSA will be used, where the surface area of the participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA.	Baseline up to Week 16
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 28	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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 28
JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Sign Score at Week 28	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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 up to Week 28
JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Symptom Score at Week 28	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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 up to Week 28
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Sign Score of 0 at Week 28	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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 28
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 28	PSSD includes PRO questionnaires designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. This PRO includes 11 items in total, with 5 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and 6 items covering participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The PSSD itch score will range from 0 to 10. 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 28
JNJ-77242113 and Ustekinumab Group: Change from Baseline in DLQI Score at Week 28	DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL It is a 10-item questionnaire that 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 up to Week 28
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 28	DLQI will be utilized in the adult population and is a dermatology specific HRQoL instrument designed to assess the impact of the disease on the HRQoL. It is a 10-item questionnaire that 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 28
JNJ-77242113 and Ustekinumab Group: Change from Baseline in BSA Score at Week 16	BSA is a commonly used measure of involvement of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed, (ie, plaque psoriasis). The handprint method for assessing BSA will be used, where the surface area of the participant's hand including the palm and all 5 digits is used as a guide to estimate 1% BSA.	Baseline up to Week 16
JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 16	IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 16
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 16	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.	Week 16
JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 16	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this 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 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants achieving at least a 100 percent improvement from baseline in the PASI score.	Week 16

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): November 17, 2025
• Study Completion (Estimated): August 20, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab
• Other Study ID Numbers: 77242113PSO3006 (Other Identifier: Janssen Research & Development, LLC); 2024-515706-77-00 (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 Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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
• product manufactured in and exported from the U.S.: Yes