A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: JNJ-77242113; Drug: JNJ-77242113 Matching Placebo; Drug: Deucravacitinib Matching Placebo; Drug: Deucravacitinib

• Study Type: Interventional
• Enrollment (Estimated): 675
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Australia
  • Benowa, Australia, 4217
    • Recruiting
    • The Skin Centre
  • Kogarah, Australia, 2217
    • Recruiting
    • Premier Specialists
  • Melbourne, Australia, 3004
    • Recruiting
    • The Alfred Hospital
  • Mitcham, Australia, 3132
    • Recruiting
    • ISHI dermatology
  • Parkville, Australia, 3050
    • Recruiting
    • Royal Melbourne Hospital
• Brazil
  • Santo Andre, Brazil, 09060-870
    • Recruiting
    • Fundacao do ABC - Centro Universitario FMABC
• Canada
  • Quebec, Canada, G1V 4X7
    • Recruiting
    • Centre de Recherche Dermatologique du Quebec Metropolitain
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Recruiting
      • Dr. Chih-ho Hong Medical
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • Wiseman Dermatology Research Inc.
  • Ontario
    • London, Ontario, Canada, N6A 5R9
      • Recruiting
      • Lovegrove Dermatology
    • Markham, Ontario, Canada, L3P 1X2
      • Recruiting
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Recruiting
      • DermEdge Research
    • Peterborough, Ontario, Canada, K9J 5K2
      • Recruiting
      • Skin Centre For Dermatology
    • Toronto, Ontario, Canada, M3H 5Y8
      • Recruiting
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M2N 3A6
      • Recruiting
      • North York Research Inc
    • Windsor, Ontario, Canada, N8T 1E6
      • Recruiting
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Recruiting
      • Innovaderm Research Inc.
• Germany
  • Augsburg, Germany, 86150
    • Recruiting
    • Hautarztpraxis Dr. Mihaescu
  • Bad Bentheim, Germany, 48455
    • Recruiting
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 13627
    • Recruiting
    • CRS Clinical Research Services Berlin GmbH
  • Bochum, Germany, 44793
    • Recruiting
    • Niesmann & Othlinghaus GbR
  • Dresden, Germany, 01307
    • Recruiting
    • Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden
  • Dulmen, Germany, 48249
    • Recruiting
    • Hautzentrum Dulmen
  • Dusseldorf, Germany, 40212
    • Recruiting
    • Privatpraxis Dr. Hilton & Partner
  • Friedrichshafen, Germany, 88045
    • Recruiting
    • Derma-Study-Center Friedrichshafen Gmbh
  • Hamburg, Germany, 20095
    • Recruiting
    • Eurofins bioskin GmbH
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitaetsklinikum Heidelberg
  • Mahlow, Germany, 15831
    • Recruiting
    • Hautarztpraxis
  • Mainz, Germany, 55131
    • Recruiting
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Merzig, Germany, 66663
    • Recruiting
    • Hautmedizin Saar
  • Muenster, Germany, 48149
    • Recruiting
    • Universitaetsklinikum Muenster
  • Oldenburg, Germany, 26133
    • Recruiting
    • Klinikum Oldenburg
  • Witten, Germany, 58453
    • Recruiting
    • Hautarztpraxis
• Hungary
  • Budapest, Hungary, 1152
    • Recruiting
    • Uno Medical Trials Ltd.
  • Gyongyos, Hungary, 3200
    • Recruiting
    • Bugat Pal Korhaz
  • Gyula, Hungary, 5700
    • Recruiting
    • Synexus Magyarorszag Kft
  • Kecskemet, Hungary, 6000
    • Recruiting
    • Bacs Kiskun Varmegyei Oktatokorhaz
  • Zalaegerszeg, Hungary, H-8900
    • Recruiting
    • Synexus Magyarorszag Kft
• Korea, Republic of
  • Ansan-si, Korea, Republic of, 15355
    • Recruiting
    • Korea University Ansan Hospital
  • Anyang-si, Korea, Republic of, 14068
    • Recruiting
    • Hallym University Sacred Heart Hospital
  • Bucheon si, Korea, Republic of, 14647
    • Recruiting
    • The Catholic University of Korea Bucheon St Mary s Hospital
  • Gwangju, Korea, Republic of, 61453
    • Recruiting
    • Chosun University Hospital
  • Seongnam, Korea, Republic of, 13496
    • Recruiting
    • CHA Bundang Medical Center, CHA University
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 8308
    • Recruiting
    • Korea University Guro Hospital
• Poland
  • Bialystok, Poland, 15 797
    • Recruiting
    • Renew Clinic
  • Katowice, Poland, 40-611
    • Recruiting
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-568
    • Recruiting
    • CARe Clinic
  • Kielce, Poland, 25-316
    • Recruiting
    • Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
  • Krakow, Poland, 30-002
    • Recruiting
    • SGD s.c.
  • Krakow, Poland, 30-303
    • Recruiting
    • Krakowskie Centrum Badan Klinicznych
  • Krakow, Poland, 31-559
    • Recruiting
    • Diamond Clinic
  • Krakow, Poland, 30-348
    • Recruiting
    • Jagiellonskie Centrum Innowacji
  • Olsztyn, Poland, 10 117
    • Recruiting
    • Etyka Osrodek Badan Klinicznych
  • Warsaw, Poland, 02-962
    • Recruiting
    • Royalderm Agnieszka Nawrocka
  • Warszawa, Poland, 02-661
    • Recruiting
    • Carpe Diem Centrum Medycyny Estetycznej
  • Warszawa, Poland, 02 672
    • Recruiting
    • Synexus Polska Sp z o o Oddzial w Warszawie
  • Wrocław, Poland, 51-685
    • Recruiting
    • WroMedica I.Bielicka, A.Strzałkowska s.c.
• Romania
  • Craiova, Romania, 200541
    • Recruiting
    • Centrul Medical Vitaplus
  • Iasi, Romania, 700381
    • Recruiting
    • Sc Iasiprest Srl
  • Timisoara, Romania, 300757
    • Recruiting
    • New Derm Clinic
• Spain
  • Alcorcon, Spain, 28922
    • Recruiting
    • Hosp. Univ. Fundacion Alcorcon
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp. Clinic de Barcelona
  • Manises, Spain, 46940
    • Recruiting
    • Hosp. de Manises
  • Salamanca, Spain, 37007
    • Recruiting
    • Hosp. Clinico Univ. de Salamanca
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hosp. Clinico Univ. de Santiago
  • Santiago de Compostela, Spain, 15702
    • Recruiting
    • Clinica Gaias
  • Sevilla, Spain, 41009
    • Recruiting
    • Hosp. Virgen Macarena
  • Sevilla, Spain, 41014
    • Recruiting
    • Hosp. Ntra. Sra. de Valme
  • Villajoyosa, Spain, 03570
    • Recruiting
    • Hosp. de La Marina Baixa
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hosp. Clinico Univ. Lozano Blesa
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 81362
    • Recruiting
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 40201
    • Recruiting
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 710
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University
  • Taipei, Taiwan, 116
    • Recruiting
    • Taipei Municipal Wanfang Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Recruiting
      • Alliance Dermatology and MOHS Center P C
  • California
    • Encinitas, California, United States, 92024
      • Recruiting
      • California Dermatology & Clinical Research Institute
    • Encino, California, United States, 91436
      • Recruiting
      • T Joseph Raoof Md Inc
    • Los Angeles, California, United States, 90056
      • Recruiting
      • Wallace Medical Group, Inc.
    • Oceanside, California, United States, 92056
      • Recruiting
      • Dermatologist Medical Group of North County, Inc.
  • Florida
    • Miami, Florida, United States, 33173
      • Recruiting
      • Miami Dermatology And Laser Institute
    • Miami, Florida, United States, 33155
      • Recruiting
      • Bioclinical Research Alliance Inc.
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Forcare Clinical Research Inc
  • Georgia
    • Douglasville, Georgia, United States, 30135
      • Recruiting
      • Southeast Dermatology Specialists
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Recruiting
      • Arlington Dermatology
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Recruiting
      • Skin Sciences, PLLC
    • Owensboro, Kentucky, United States, 42301
      • Recruiting
      • Qualmedica Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • DermAssociates, PC
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Metro Boston Clinical Partners
    • Methuen, Massachusetts, United States, 01844
      • Recruiting
      • ActivMed Practices and Research
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Recruiting
      • Great Lakes Research Group
    • Caledonia, Michigan, United States, 49316
      • Recruiting
      • The Derm Institute of West Michigan
    • Canton, Michigan, United States, 48187
      • Recruiting
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Somerset Skin Centre
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • Recruiting
      • Cleaver Dermatology
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Recruiting
      • Bexley Dermatology Research
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Recruiting
      • Essential Medical Research
  • Oregon
    • Portland, Oregon, United States, 97210-2996
      • Recruiting
      • Oregon Dermatology & Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Recruiting
      • Paddington Testing Co, Inc.
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Recruiting
      • Clinical Research Center of the Carolinas LLC
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Recruiting
      • Arlington Research Center, Inc.
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Dermatology Clinical Research Center of San Antonio
    • Webster, Texas, United States, 77598
      • Recruiting
      • Center for Clinical Studies
  • Utah
    • Bountiful, Utah, United States, 84010
      • Recruiting
      • Cope Family Medicine - Ogden Clinic
    • Springville, Utah, United States, 84663
      • Recruiting
      • Springville Dermatology CCT Research
    • West Valley City, Utah, United States, 84120
      • Recruiting
      • Kalo Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Dermatology Skin Cancer Center Pllc

Participation Criteria

Eligibility Criteria

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

Description

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

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: JNJ-77242113; Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.; Drug: Deucravacitinib Matching Placebo; Deucravacitinib matching placebo will be administered orally.
Placebo Comparator: Placebo; Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.; Drug: JNJ-77242113 Matching Placebo; JNJ-77242113 matching placebo will be administered orally.; Drug: Deucravacitinib Matching Placebo; Deucravacitinib matching placebo will be administered orally.
Active Comparator: Deucravacitinib; Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.	Drug: JNJ-77242113; JNJ-77242113 will be administered orally.; Drug: JNJ-77242113 Matching Placebo; JNJ-77242113 matching placebo will be administered orally.; Drug: Deucravacitinib; Deucravacitinib will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
JNJ-77242113 and Placebo Group: 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 and Week 16
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	Percentage of participants achieving an IGA score of 0 or 1 and >=2 grade improvement from baseline 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).	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 165 weeks
JNJ-77242113 and Placebo Group: 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 and Week 8
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16	Percentage of participants achieving PASI 100 response (100% 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 and Week 16
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24	Percentage of participants who achieve an IGA score of 0 at Weeks 16 and 24 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).	Weeks 16 and 24
Number of Participants with Serious Adverse Events (SAEs)	SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.	Up to 165 weeks
Change From Baseline in Body Surface Area (BSA) at Week 16	Change from baseline in BSA at 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 and Week 16
Percent Improvement in PASI Score From Baseline at Week 16	Percent improvement in PASI score 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 and Week 16
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	Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement from baseline to 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).	Baseline and Week 16
JNJ-77242113 and Placebo Group: 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 first 3 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 and Week 16
JNJ-77242113 and Placebo Group: 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]).	Week 16
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	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
JNJ-77242113 and Placebo Group: 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 and Week 16
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	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 and Week 16
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24	Percentage of participants achieving DLQI score of 0 or 1 at Weeks 16 and 24 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.	Weeks 16 and 24
Percentage of Participants Who Achieve PASI 75 Response After Week 24 Among PASI 75 Non-responders to Deucravacitinib at Week 24	Percentage of participants who achieve PASI 75 response (>=75% improvement in PASI) after Week 24 among PASI 75 Non-responders to deucravacitinib at Week 24 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 and from Week 24 through Week 156
Percentage of Participants Who Achieve PASI 90 Response After Week 24 Among PASI 90 Non-responders to Deucravacitinib at Week 24	Percentage of participants who achieve PASI 90 response (>=90% improvement in PASI) after Week 24 among PASI 90 non-responders to deucravacitinib at Week 24 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 and from Week 24 through Week 156
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	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 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).	From Week 24 through Week 156
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16	Percentage of participants achieving 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
JNJ-77242113 and Placebo Group: 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, Weeks 4 and 16
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	Percentage of participants achieving ss-IGA score of 0 or 1 and a >=2-grade improvement from baseline at 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 and Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Weeks 8 and 16	Percentage of participants achieving PSSD symptoms score of 0 at Weeks 8 and 16 will be reported. The PSSD is a self-administered patient-reported outcome (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
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16	Percentage of participants achieving >=4 Point improvement from baseline in PSSD itch score at Weeks 4 and 16 will be reported. 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, Weeks 4 and 16
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	Percentage of participants who achieve an IGA score of 0 or 1 and >=2 grade improvement from baseline at Weeks 16 and 24 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, Weeks 16 and 24
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24	Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 16 and 24 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, Weeks 16 and 24
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24	Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Weeks 16 and 24 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, Weeks 16 and 24
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24	Percentage of participants achieving PASI 100 response (>=100% improvement in PASI) at Weeks 16 and 24 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.	Weeks 16 and 24
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants With PSSD Symptom Score of 0 at Week 16	Percentage of participants achieving PSSD symptom score 0 at Week 16 will be reported. 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
Change from Baseline in PASI Score at Week 16	Change from baseline in PASI score 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 are 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 and Week 16
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	Percentage of participants achieving a sPGA-G Score of 0 or 1 and >=2-grade improvement 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 and Week 16
JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Symptom Score at Week 16	Change from baseline in PSSD symptom score at Week 16 will be reported. 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 and Week 16
JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Sign Score at Week 16	Change from baseline in PSSD sign score at Week 16 will be reported. 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 and Week 16
JNJ-77242113 and Placebo Group: Percentage of Participants With PSSD Sign Score of 0 at Week 16	Percentage of participants with PSSD sign score of 0 at Week 16 will be reported. 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
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 at Week 16	Percentage of participants achieving DLQI total 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
JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PSSD Symptom Score of 0 at Week 24	Percentage of participants achieving PSSD symptom score of 0 at Week 24 will be reported. 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 24

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2024
• Primary Completion (Estimated): February 10, 2025
• Study Completion (Estimated): September 20, 2027

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: 77242113PSO3004 (Other Identifier: Janssen Research & Development, LLC)

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