A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

July 2, 2026 updated by: Janssen Research & Development, LLC

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 see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

Study Overview

Status

Active, not recruiting

Conditions

Plaque Psoriasis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

774

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, B1643CRO
    - Instituto Medico De Alta Complejidad (IMAC)
  - Buenos Aires, Argentina, C1406AGA
    - ARCIS Salud SRL Aprillus asistencia e investigacion
  - CABA, Argentina, C1425BEA
    - Instituto de Neumonologia Y Dermatologia
  - Caba, Argentina, C1199ABD
    - Hospital Italiano de Buenos Aires
  - Caba, Argentina, C1122AAF
    - Halitus Instituto Medico S.A. - Dermatologia y Estetica
  - La Plata, Argentina, B1900AXI
    - Hospital Italiano de La Plata
  - Rosario, Argentina, S2000PBJ
    - Instituto Caici Srl.
  - San Miguel de Tucumán, Argentina, T4000AXL
    - Centro de Investigaciones Médicas Tucuman
Australia
- - Campbelltown, Australia, 5074
    - North Eastern Health Specialists
  - Canberra, Australia, 2606
    - Paratus Clinical Research Woden
  - East Melbourne, Australia, 3002
    - Sinclair Dermatology
  - Melbourne, Australia, 3053
    - Skin Health Institute Inc.
  - Woolloongabba, Australia, 4102
    - Veracity Clinical Research
Brazil
- - Santo André, Brazil, 09060-870
    - Fundacao do ABC Centro Universitario FMABC
Canada
- British Columbia
  - Surrey, British Columbia, Canada, V3V 0C6
    - Enverus Medical
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
    - Karma Clinical Trials Inc.
- 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
  - Richmond Hill, Ontario, Canada, L4B1L1
    - York Dermatology Clinic and Research Centre
  - Waterloo, Ontario, Canada, N2J 1C4
    - Alliance Clinical Trials
  - Windsor, Ontario, Canada, N8T 1E6
    - XLR8 Medical Research
Germany
- - Berlin, Germany, 10789
    - ISA - Interdisciplinary Study Association GmbH
  - Bramsche, Germany, 49565
    - Hautarztpraxis 3
  - Dresden, Germany, 01069
    - Klinische Forschung Dresden GmbH
  - Dresden, Germany, 01097
    - Praxis fuer Dermatologie und Venerologie
  - Düsseldorf, Germany, 40225
    - Universitaetsklinikum Duesseldorf
  - Hamburg, Germany, 22391
    - MensingDerma Research GmbH
  - Hamburg, Germany, 20246
    - Universitaetsklinikum Hamburg Eppendorf
  - Kiel, Germany, 24105
    - Universitaetsklinikum Schleswig Holstein Campus Kiel
  - Langenau, Germany, 89129
    - Studienzentrum Dr Schwarz Germany
  - Leipzig, Germany, 04103
    - Universitätsklinikum Leipzig AöR
  - Lübeck, Germany, 23562
    - Universitatsklinikum Schleswig Holstein Campus Lubeck
  - Mannheim, Germany, 68167
    - Universitaetsklinikum Mannheim
  - München, Germany, 80802
    - Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein
  - Potsdam, Germany, 14467
    - Hautarztpraxis 1
  - Rostock, Germany, 18057
    - Universitaetsmedizin Rostock
Hungary
- - Borgyogyaszati Klinika, Hungary, 7632
    - Pecsi Tudomanyegyetem
  - Budapest, Hungary, 1036
    - Obudai Egeszsegugyi Centrum Kft
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont
  - Debrecen, Hungary, 4031
    - Derma-B Kft
  - Kaposvár, 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.
  - Veszprém, Hungary, 8200
    - Medmare Egeszsegugyi Es Szolgaltato Bt.
Japan
- - Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital
  - Fukutsu, Japan, 811-3217
    - Hino Dermatology Clinic
  - Gifu, Japan, 501-1112
    - Gifu University Hospital
  - Ginowan, Japan, 901 2725
    - University of the Ryukyus Hospital
  - Gunma, Japan, 371 8511
    - Gunma University Hospital
  - Hokkaido, Japan, 060-0033
    - JR Sapporo Hospital
  - Hokkaido, Japan, 078 8510
    - Asahikawa Medical University Hospital
  - Isehara, Japan, 259-1193
    - Tokai University Hospital
  - Itabashi Ku, Japan, 173 8606
    - Teikyo University Hospital
  - Kawasaki, Japan, 216 8511
    - St Marianna University Hospital
  - Kitakyushu-shi, Japan, 807-8556
    - Hospital of the University of Occupational and Environmental Health
  - Nagoya, Japan, 467 8602
    - Nagoya City University Hospital
  - Nishiku, Japan, 593-8324
    - Kume Clinic
  - Obihiro Shi, Japan, 080 0013
    - Takagi Dermatological Clinic
  - Osaka, Japan, 550 0006
    - Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
  - Sakai, Japan, 590 0197
    - Kindai University Hospital
  - Sapporo, Japan, 060 0063
    - Sapporo Skin Clinic
  - Sendai, Japan, 980 8574
    - Tohoku University Hospital
  - Suita, Japan, 565 0871
    - The University of Osaka Hospital
  - Tachikawa, Japan, 190 0023
    - Jitaikai Tachikawa dermatology clinic
  - Takaoka Shi, Japan, 933-0871
    - Shirasaki dermatology clinic
  - Tokyo, Japan, 160-0023
    - Tokyo Medical University Hospital
  - Tsu, Japan, 514 8507
    - Mie University Hospital
Poland
- - Bialystok, Poland, 15-351
    - Osteo-Medic s.c A. Racewicz, J Supronik
  - Bialystok, Poland, 15-375
    - Specderm Poznanska sp j
  - Elblag, Poland, 82 300
    - Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  - Krakow, Poland, 31-411
    - Centrum Medyczne Promed
  - Krakow, Poland, 30 438
    - Centrum Medyczne dr Rajzer Sp z o o
  - Krakow, Poland, 30-002
    - Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
  - 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 Rafal Czajkowski S C
  - Poznan, Poland, 61 731
    - Clinical Research Center sp z o o MEDIC R s k
  - Poznan, Poland, 60 529
    - SOLUMED Centrum Medyczne
  - Warsaw, Poland, 02 953
    - Klinika Ambroziak Dermatologia
  - Warsaw, Poland, 01 817
    - Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
  - Wroclaw, Poland, 51 503
    - DERMMEDICA Sp.z o.o.
  - Wroclaw, Poland, 52 416
    - Centrum Medyczne Oporow
  - Wroclaw, Poland, 51 685
    - Wro Medica
South Korea
- - Busan, South Korea, 49241
    - Pusan National University Hospital
  - Seongnam-si, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 03080
    - Seoul National University Hospital
  - Seoul, South Korea, 06591
    - The Catholic University of Korea Seoul St Marys Hospital
  - Seoul, South Korea, 05030
    - Konkuk University Medical Center
  - Seoul, South Korea, 04763
    - Hanyang University Medical Center
  - Seoul, South Korea, 130 050
    - Kyung Hee University Hospital
Spain
- - Alicante, Spain, 03010
    - Hosp. Gral. Univ. Dr. Balmis
  - Barakaldo, Spain, 48902
    - Hosp. Univ. de Cruces
  - Barcelona, Spain, 08041
    - Hosp. de La Santa Creu I Sant Pau
  - Granada, Spain, 18016
    - Hosp. Univ. San Cecilio
  - L'Hospitalet de Llobregat, Spain, 08907
    - Hosp. Univ. de Bellvitge
  - Madrid, Spain, 28041
    - Hosp. Univ. 12 de Octubre
  - Madrid, Spain, 28007
    - Hosp. Gral. Univ. Gregorio Maranon
  - Madrid, Spain, 28031
    - Hosp. Univ. Infanta Leonor
  - Madrid, Spain, 28006
    - Hosp. Univ. de La Princesa
  - Madrid, Spain, 28046
    - Hosp. Univ. de La Paz
  - Madrid, Spain, 28002
    - Grupo Dermatologico Y Estetico Pedro Jaen
  - Valencia, Spain, 46026
    - Hosp. Univ. I Politecni La Fe
Taiwan
- - Hsinchu, Taiwan, 30059
    - National Taiwan University Hospital Hsin Chu Branch
  - Kaohsiung City, Taiwan, 833
    - Chang Kung Memorial Hospital
  - New Taipei City, Taiwan, 235
    - Taipei Medical University Shuang Ho Hospital
  - Taipei, Taiwan, 112
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 10048
    - National Taiwan University Hospital
  - Taipei, Taiwan, 10449
    - Taipei Mackay Memorial Hospital
  - Taoyuan, Taiwan, 33382
    - Linkou Chang Gung Memorial Hospital
United Kingdom
- - 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, SO16 6YD
    - University Hospital Southampton NHS Foundation Trust
United States
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Medical Dermatology Specialists
  - Scottsdale, Arizona, United States, 85260
    - Center for Dermatology and Plastic Surgery
- 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
  - Santa Ana, California, United States, 92701
    - Southern California Dermatology
  - Santa Monica, California, United States, 90403
    - Clinical Science Institute
- Florida
  - Miami, Florida, United States, 33126
    - Driven Research LLC
  - North Miami Beach, Florida, United States, 33162
    - Ziaderm Research LLC
  - 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
  - Macon, Georgia, United States, 31217
    - Skin Care Physicians of Georgia
- Illinois
  - Chicago, Illinois, United States, 60602
    - DeNova Research
  - Rolling Meadows, Illinois, United States, 60008
    - Arlington Dermatology
  - Skokie, Illinois, United States, 60077
    - Endeavor Health
  - 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
  - Louisville, Kentucky, United States, 40241
    - Dermatology Specialists
- Louisiana
  - Lake Charles, Louisiana, United States, 70605
    - Dermatology and Advanced Aesthetics
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48103
    - David Fivenson MD, Dermatology
  - Clarkston, Michigan, United States, 48346
    - Michigan Center of Medical Research
  - Detroit, Michigan, United States, 48202
    - Henry Ford Medical Center
  - Fort Gratiot, Michigan, United States, 48059
    - Hamzavi Dermatology
- Missouri
  - Saint Joseph, Missouri, United States, 64506
    - MediSearch Clinical Trials
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Skin Specialists
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Fife Dermatology
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Stracskin
- New Jersey
  - East Windsor, New Jersey, United States, 08520
    - Schweiger Dermatology Group
  - Hackensack, New Jersey, United States, 07601
    - Schweiger Dermatology Group 1
- New York
  - Stony Brook, New York, United States, 11790
    - Derm Research Center of New York, Inc.
- 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
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73170
    - Central Sooner Research
- Oregon
  - Portland, Oregon, United States, 97201
    - Oregon Medical Research Center
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Health Concepts
- Texas
  - Dallas, Texas, United States, 75231
    - Modern Research Associates
  - Houston, Texas, United States, 77004
    - Center for Clinical Studies 1
  - Houston, Texas, United States, 77056
    - Austin Institute for Clinical Research 1
  - Pflugerville, Texas, United States, 78660
    - Austin Institute for Clinical Research
  - 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
- Virginia
  - Richmond, Virginia, United States, 23294
    - National Clinical Research
- Washington
  - Mill Creek, Washington, United States, 98012
    - Frontier Derm Partners CRO, LLC
  - Spokane, Washington, United States, 99202
    - Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Greater Than or Equal to (>=) 2-Grade Improvement From Baseline at Week 16 Time Frame: Week 16	IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema, scaling, each using 5 point scale. Induration:0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25 millimeters(mm); 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation,>1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over less than 5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe(4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.	Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 Time Frame: Week 16	Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Body Surface Area (BSA) at Week 16 Time Frame: Baseline (Week 0), Week 16	A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of 0 at Week 16 Time Frame: Week 16	The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.	Week 16
Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Among Participants With a Baseline PSSD Symptom Score >0 Time Frame: Weeks 8 and 16	PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Weeks 8 and 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Among Participants With a Baseline PSSD Itch Score >=4 Time Frame: Weeks 4 and 16	PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.	Weeks 4 and 16
Percentage of Participants Who Achieved an IGA Score of 0 at Weeks 16 and 24 Time Frame: Weeks 16 and 24	The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, >1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.	Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Sign Score of 0 at Week 16 Among Participants With a Baseline Sign Score >0 Time Frame: Week 16	PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percentage of Participants Who Achieved Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With a Baseline GenPS-SFQ Item 2 Score >=2 and With a Baseline sPGA-G Score >=3 Time Frame: Week 16	The GenPs-SFQ was 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 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, or 4 = always). Lower scores of item 2 indicated less limitation of sexual activity due to genital psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percentage of Participants Who Achieved Dermatological Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1 Time Frame: Week 16	The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percentage of Participants Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 24 Among Participants With a Baseline DLQI Score >1 Time Frame: Weeks 16 and 24	The DLQI was a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 at Weeks 4 and 16 Time Frame: Weeks 4 and 16	Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 4 and 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Weeks 4 and 16
Percentage of Participants Who Achieved PASI 90 at Week 8 Time Frame: Week 8	Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 8 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 8
Percentage of Participants Who Achieved PASI 100 at Week 16 Time Frame: Week 16	Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percentage of Participants Who Achieved a Scalp Specific (ss)-IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 16 Among Participants With a Baseline Ss-IGA Score >=2 Time Frame: Week 16	The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percentage of Participants Who Achieved an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Weeks 16 and 24 Time Frame: Weeks 16 and 24	IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation, =0.25 mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75 mm; 4=severe plaque elevation, >1 mm; Erythema: 0=no evidence of erythema, hyperpigmentation may be present, 1=faint erythema, 2=light red coloration, 3=moderate red coloration, 4=bright red coloration; Scaling: 0=no evidence of scaling, 1=minimal; occasional fine scale over <5% of lesion, 2=mild; fine scale dominates, 3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score=more severe disease. Baseline=closest measurement taken prior to or at time of first study drug administration date.	Weeks 16 and 24
Percentage of Participants Who Achieved PASI 75 at Weeks 16 and 24 Time Frame: Weeks 16 and 24	Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Weeks 16 and 24
Percentage of Participants Who Achieved PASI 90 at Weeks 16 and 24 Time Frame: Weeks 16 and 24	Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Weeks 16 and 24
Percentage of Participants Who Achieved PASI 100 at Weeks 16 and 24 Time Frame: Weeks 16 and 24	Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Weeks 16 and 24 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Weeks 16 and 24
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 16 Among Participants With a Baseline Symptom Score >0 Time Frame: Week 16	PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date	Week 16
Change From Baseline in PASI Total Score at Week 16 Time Frame: Baseline (Week 0), Week 16	Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percent Change From Baseline in PASI Total Score at Week 16 Time Frame: Baseline (Week 0), Week 16	Percent change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline sPGA-G Score >=2 Time Frame: Week 16	The sPGA-G was 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 was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percentage of Participants Who Achieved Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and a >=2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2 Time Frame: Week 16	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. hf-PFA was categorized from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher score indicates more severity. Meeting the hf-PGA 0 or 1 criteria defined as having an hf-PGA score of clear (0) or almost clear (1) and a >=2-grade improvement from baseline. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Among Participants With a Baseline mNAPSI Score >0 Time Frame: Baseline (Week 0), Week 16	Percent change from baseline in mNAPSI score at week 16 was reported. The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails were evaluated on 7 features. The first three features were each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. Next four features was each scored 0 absent or 1 present, and are (1) leukonychia, (2) splinter hemorrhages (3) nail bed hyperkeratosis, and (4) red spots in lunula. Each fingernail was rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). Total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). Higher the score the more severe the nail bed psoriasis. Baseline = closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Percentage of Participants Who Achieved Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With Baseline f-PGA Score >=2 Time Frame: Week 16	Percentage of participants who achieved f-PGA score of 0 or 1 at Week 16 was reported. f-PGA 0 or 1 criteria was defined as an f-PGA score of clear (0) or minimal (1). The f-PGA is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Change From Baseline in PSSD Symptom Score at Week 16 Time Frame: Baseline (Week 0), Week 16	Change from baseline in PSSD symptoms score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date	Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at Week 16 Time Frame: Baseline (Week 0), Week 16	Change from baseline in PSSD sign score at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Sign score was derived by averaging the 6 weekly sign item scores when at least 3 items are available (>=50% of 6 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Change From Baseline in Total DLQI Score at Week 16 Time Frame: Baseline (Week 0), Week 16	Change from baseline in total DLQI score at Week 16 was reported. The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could 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. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Baseline (Week 0), Week 16
Change From Baseline in Domain Scores of the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16 Time Frame: Baseline (Week 0), Week 16	PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.	Baseline (Week 0), Week 16
Percentage of Participants Who Achieved PSSD Symptom Score of 0 at Week 24 Among Participants With Baseline Symptom Score >0 Time Frame: Week 24	PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 24-hour recall version was used. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Each individual item score over seven days was averaged into a weekly item score. Symptom score was derived by averaging the 5 weekly symptom item scores when at least 3 items are available (>=50% of 5 items). Average score was then multiplied by 10 to convert into 0-100 scoring (0-least severe, 100-most severe). The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date	Week 24
Percentage of Participants Who Achieved PASI 75 After Week 24, Among PASI 75 Nonresponders to Deucravacitinib at Week 24 Time Frame: Week 24 up to Week 160		Week 24 up to Week 160
Percentage of Participants Who Achieved PASI 90 After Week 24, Among PASI 90 Nonresponders to Deucravacitinib at Week 24 Time Frame: Week 24 up to Week 160		Week 24 up to Week 160
Percentage of Participants Who Achieved IGA Score of 0 or 1 After Week 24, Among Participants in the Deucravacitinib Group With IGA Score >=2 at Week 24 Time Frame: Week 24 up to Week 160		Week 24 up to Week 160
Number of Participants With Adverse Events (AEs) Time Frame: From Week 0 to Week 160		From Week 0 to Week 160
Number of Participants With Serious Adverse Events (SAEs) Time Frame: From Week 0 to Week 160		From Week 0 to Week 160

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinicaltrial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gold LS, Armstrong AW, Bissonnette R, Magnolo N, Vender RB, Sebastian M, Galimberti ML, Tsianakas A, Arnone M, Wallace P, Simon M, Riera-Monroig J, Gerdes S, Waibel J, Gonzalez-Cantero A, Schwarz B, Tada Y, Cecchini M, Ehst B, Kircik L, Kephart L, Reyes-Servin O, Edem BE, Campbell JH, Shen YK, Cresswell K, Li S, DeKlotz CMC, Nunes F, Papp KA. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025 Sep 27;406(10510):1363-1374. doi: 10.1016/S0140-6736(25)01576-4. Epub 2025 Sep 18.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

September 17, 2024

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

77242113PSO3002 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product