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

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

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

Study Overview

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

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

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1417EYG
    • Centro Privado de Medicina Familiar
  • Buenos Aires, Argentina, C1406AGA
    • ARCIS Salud SRL Aprillus asistencia e investigacion
  • Buenos Aires, Argentina, C1426
    • Derma Internacional S A
  • CABA, Argentina, C1425DKG
    • Psoriahue
  • Mar del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Medicas Mar del Plata
  • Rosario, Argentina, S2000DBS
    • Instituto De Especialidades De La Salud SRL
  • San Fernando, Argentina, B1646
    • MR Medicina Reumatologica
• Australia
  • East Melbourne, Australia, 3002
    • Dr Rodney Sinclair Pty Ltd
  • Melbourne, Australia, 3004
    • The Alfred Hospital
  • Miranda, Australia, 2228
    • Kingsway Dermatology & Aesthetics
  • Mitcham, Australia, 3132
    • ISHI dermatology
  • Parkville, Australia, 3050
    • Royal Melbourne Hospital
  • Woolloongabba, Australia, 4102
    • Veracity Clinical Research
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Dermatology Clinic Edmonton Downtown
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih ho Hong Medical
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dr Wei Jing Loo Medicine Professional Corporation
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research Inc.
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Ryan Clinical Research Inc
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Center
    • Toronto, Ontario, Canada, M4C 1L1
      • Facet Dermatology
    • Windsor, Ontario, Canada, N8T 1E6
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital Capital Medical University
  • Beijing, China, 100013
    • China Japan Friendship Hospital
  • Bengbu, China, 233099
    • The Affiliated Hospital of Bengbu Medical College
  • Chengde, China, 067030
    • Hosp. of Chengde Medical University
  • Chengdu, China, 610017
    • Chengdu Second People's Hospital
  • Jiaxing, China, 314001
    • The First Hospital of Jiaxing
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University
  • Nanchang, China, 330000
    • Dermatology Hospital of Jiangxi Province
  • Nanyang, China, 473004
    • Nanyang First People's Hospital
  • Shanghai, China, 200443
    • Shanghai Skin Disease Hospital
  • Shenyang, China, 110016
    • Northeast International Hospital
  • Wuhan, China, 430022
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xi'an, China, 710004
    • The second Affiliated Hospital of Xi'an Jiaotong University
  • Zhenjiang, China, 212001
    • Affiliated Hospital of Jiangsu University
• France
  • Antony, France, 92160
    • Hôpital Privé d'Antony
  • Argenteuil, France, 95107
    • Centre Hospitalier Victor Dupouy
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10117
    • Charite - Campus Mitte
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden GmbH
  • Dülmen, Germany, 48249
    • Hautzentrum Dulmen
  • Düsseldorf, Germany, 40212
    • Privatpraxis Dr. Hilton & Partner
  • Frankfurt am Main, Germany, 60590
    • Universitaetsklinikum Frankfurt
  • Freiburg im Breisgau, Germany, 79104
    • Universitaetsklinikum Freiburg
  • Friedrichshafen, Germany, 88045
    • Derma-Study-Center Friedrichshafen GmbH
  • Heidelberg, Germany, 69120
    • UniversitaetsKlinikum Heidelberg
  • Mahlow, Germany, 15831
    • Hautarztpraxis
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg
  • Remscheid, Germany, 42897
    • Hautarztpraxis Mortazawi
  • Tübingen, Germany, 72076
    • Universitaetsklinik Tuebingen
  • Witten, Germany, 58453
    • Hautarztpraxis 2
  • Wuppertal, Germany, 42287
    • CentroDerm GmbH
• 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.
• Italy
  • Palermo, Italy, 90127
    • Azienda Di Rilievo Nazionale E Di Alta Specializzazione
  • Parma, Italy, 43126
    • Azienda Ospedaliero Universitaria di Parma
  • Roma, Italy, 00133
    • Policlinico Tor Vergata
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• Japan
  • Itabashi Ku, Japan, 173 8606
    • Teikyo University Hospital
  • Kitakyushu-shi, Japan, 807-8556
    • Hospital of the University of Occupational and Environmental Health
  • Mito, Japan, 310 0015
    • Mito Kyodo General Hospital
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Osaka Sayama Shi, Japan, 589 8511
    • Kindai University Hospital
  • Sendai, Japan, 980 8574
    • Tohoku University Hospital
  • Shinjuku, Japan, 160 0023
    • Tokyo Medical University Hospital
  • Tsu, Japan, 514 8507
    • Mie University Hospital
• 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
  • Ansan-si, South Korea, 15355
    • Korea University Ansan Hospital
  • Gwangju, South Korea, 61453
    • Chosun university hospital
  • Gyeonggi-do, South Korea, 13496
    • CHA Bundang Medical Center, CHA University
  • Gyeonggi-do, South Korea, 14068
    • Hallym University Sacred Heart Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
• Spain
  • Alcorcón, Spain, 28922
    • Hosp. Univ. Fundacion Alcorcon
  • Alicante, Spain, 03010
    • Hosp. Gral. Univ. Dr. Balmis
  • Barcelona, Spain, 08041
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Bilbao, Spain, 48013
    • Hosp. Univ. de Basurto
  • Madrid, Spain, 28007
    • Hosp. Gral. Univ. Gregorio Maranon
  • Madrid, Spain, 28002
    • Grupo Dermatologico Y Estetico Pedro Jaen
  • Palma de Mallorca, Spain, 07120
    • Hosp. Univ. Son Espases
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Valencia, Spain, 46940
    • Hosp. de Manises
• Taiwan
  • Hsinchu, Taiwan, 30059
    • National Taiwan University Hospital Hsin Chu Branch
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33382
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Medical Faculty
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Medical Faculty
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes University Medical Faculty
  • Samsun, Turkey (Türkiye), 55270
    • Ondokuz Mayis University
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • London North West University Healthcare NHS Trust
  • London, United Kingdom, SE1 9RT
    • Guys and St Thomas NHS Foundation Trust
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • San Diego, California, United States, 92123
      • Rady Childrens Hospital San Diego
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
    • Santa Monica, California, United States, 90403
      • Clinical Science Institute
  • Florida
    • Miami, Florida, United States, 33155
      • Bioclinical Research Alliance Inc.
    • North Miami Beach, Florida, United States, 33162
      • Ziaderm Research LLC
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research Inc
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077
      • 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
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Dermatology and Advanced Aesthetics
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research 1
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Michigan Center of Medical Research
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Schweiger Dermatology Group
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Athens, Ohio, United States, 45701
      • Oakview Dermatology
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Fairborn, Ohio, United States, 45324
      • Dermatologists of Central States LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • Central Sooner Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • The Pennsylvania Centre for Dermatology, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Bellaire, Texas, United States, 77401
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies 1
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies
  • Utah
    • Springville, Utah, United States, 84663
      • Springville Dermatology CCT Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology Skin Cancer Center Pllc
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Derm Partners CRO, LLC
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
• Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
• Total psoriasis area and severity index (PASI) >=12 at screening and baseline
• Total investigator global assessment (IGA) >=3 at screening and baseline
• Candidate for phototherapy or systemic treatment for plaque psoriasis
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Exclusion Criteria:

• Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
• Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
• Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved 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	IGA assesses participant's plaque psoriasis.Lesions were graded for induration,erythema and 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,=0.5mm;3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation, greater than(>)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 a 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 Response at Week 16	Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were 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 were 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 PASI Total Score at 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 were 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 IGA Score of 0 at 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 millimeter (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 PASI 75 Response at Week 4	Percentage of participants who achieved PASI 75 (at least >=75% improvement from baseline in PASI) response at Week 4 were 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 were 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 4
Percentage of Participants Who Achieved PASI 90 Response at Week 8	Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 8 were 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 were 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 75 Response at Week 16	Percentage of participants who achieved PASI 75 (>=75% improvement from baseline in PASI) response at Week 16 were 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 were 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 PASI 100 Response at Week 16	Percentage of participants who achieved PASI 100 (100% improvement from baseline in PASI) response at Week 16 were 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 were 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 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	The ss-IGA instrument is 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 are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. Higher score indicated 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 Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 8 Among Participants With a Baseline PSSD Symptom Score >0	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 first 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 8
Percentage of Participants Who Achieved Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Week 16 Among Participants With a Baseline PSSD Symptom Score >0	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 first 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
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 4 Among Participants With a Baseline PSSD Itch Score >=4	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.	Week 4
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a Baseline PSSD Itch Score >=4	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.	Week 16
Percentage of Participants Who Achieved PASI 75 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24	Percentage of participants who achieved PASI-75 score (>=75% improvement from baseline in PASI) at Week 52 among participants randomized at Week 24 and were PASI 75 responders at Week 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 were 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. Baseline=closest measurement taken prior to or at time of first study drug administration date.	Week 52
Percentage of Participants Who Achieved PASI 90 Response at Week 52 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24	Percentage of participants who achieved PASI 90 (at least >=90% improvement from baseline in PASI) response at Week 52 among participants randomized at Week 24 and were PASI 90 responders at Week 24 were reported. 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 were 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. Baseline=closest measurement taken prior to or at time of first study drug administration date.	Week 52
Time to Loss of PASI 75 Among Participants Randomized at Week 24 and Were PASI 75 Responders at Week 24	Time to loss of PASI 75 response was defined as time from re-randomization at Week 24 to visit of loss of PASI 75 response. Loss of PASI 75 response was defined as less than (<)75% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=75% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were 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). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.	Week 24 up to Week 52
Time to Loss of PASI 90 Among Participants Randomized at Week 24 and Were PASI 90 Responders at Week 24	The time to loss of PASI 90 response was defined as the time from re-randomization at Week 24 to the visit of loss of PASI 90 response. Loss of PASI 90 response is defined as <90% improvement in PASI from Week 24 up to Week 52 in an adult participant who had achieved >=90% improvement in PASI from baseline at Week 24. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas were 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). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.	Week 24 up to Week 52
Change From Baseline in Body Surface Area (BSA) at 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
Percent Change From Baseline in PASI Total Score at 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 were 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 in Genital Psoriasis From Baseline at Week 16 Among Participants With a Baseline sPGA-G Score >=2	Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement in genital psoriasis from baseline at Week 16 among participants with a baseline sPGA-G score >=2 was reported. 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 Achieving a Physician's Global Assessment of Hands and Feet (Hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement at Week 16 Among Participants With a Baseline Hf-PGA Score >=2	Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement at Week 16 among participants with a baseline hf-PGA score >=2 was 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. 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 Baseline mNAPSI Score >0	The mNAPSI was an index used for assessing and grading the severity of nail psoriasis. Each of the participant's ten fingernails are evaluated on 7 features. The first three features are each scored from 0 to 3 in severity and were 1 = onycholysis and oil-drop dyschromia, 2 = pitting, and 3 = nail plate crumbling. The 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 the lunula. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). The higher the score the more severe the nail bed 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 Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Among Participants With a Baseline f-PGA Score >=2	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. 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
Change From Baseline in PSSD Symptom Score at 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.	Baseline (Week 0), Week 16
Change From Baseline in PSSD Sign Score at 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.	Baseline (Week 0), Week 16
Percentage of Participants Achieving PSSD Sign Score of 0 at Week 16 Among Participants With Baseline PSSD Sign Score >0	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 Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Among Participants With Baseline GenPS-SFQ Item 2 Score >=2 and a Baseline sPGA-G Score >=3	Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 among participants with baseline GenPS-SFQ Item 2 score >=2 and a baseline sPGA-G score >=3 was reported. 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 Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline DLQI Score >1	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
Change From Baseline in Total DLQI Score at 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
Adult Participants: Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at 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 that is, 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
Adolescent Participants: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score >1	The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.	Week 16
Adolescent Participants: Change From Baseline in CDLQI at Week 16	The CDLQI was an adapted version of the DLQI for the pediatric population and was utilized in the adolescent population in this study. The CDLQI is a 10-item instrument that has 4 item response options and a recall period of 1 week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. The instrument is designed for use in children, is self-explanatory and can be simply handed to the participant who asked to fill it in with the help of the child's parent or caregiver. 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
Adolescent Participants: Change From Baseline in Domain Scores of the PROMIS-25 Pediatric Score at Week 16	The PROMIS-25 was utilized in the adolescent population and is a 25-item generic HRQoL survey. Six PROMIS domains (physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference) are each assessed with 4 questions. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Higher score=worst pain. Raw scores for each domain were converted to T-scores using standardized score with a mean of 50 and a standard deviation (SD) of 10 with an observed range 20 to 80. For anxiety, depressive symptoms, fatigue, and pain interference, a negative change indicates an improvement while for physical function mobility and peer relationships, a positive change indicates an improvement. 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 an IGA Score of 0 or 1 and >=2-Grade Improvement From Baseline at Week 52	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, =0.25mm; 2=mild plaque elevation, =0.5 mm; 3=moderate plaque elevation, =0.75mm;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 of psoriasis was based upon average of induration,erythema and scaling scores assessed on a 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 52
Percentage of Participants Achieving IGA Score of 0 at Week 52 Among Participants Who Were IGA 0 Responders at Week 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.	Week 52
Percentage of Participants Achieving PASI 100 Response at Week 52 Among PASI 100 Responders at Week 24	Percentage of participants achieving PASI 100 (100% improvement from baseline in PASI) response at Week 52 among PASI 100 responders at Week 24 were 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 were 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.	Week 52
Time to Loss of IGA Response of 0 or 1	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 24 up to Week 52
Adolescent Participants: Percentage of Participants With IGA Score of 0 or 1 and a >=2-grade Improvement From Baseline at Week 52	IGA assesses participant's plaque psoriasis. Lesions were graded for induration,erythema and scaling,each using 5 point scale. Induration: 0=no evidence of plaque elevation, 1=minimal plaque elevation,=0.25mm; 2=mild plaque elevation,=0.5 mm; 3=moderate plaque elevation,= 0.75 mm; 4=severe plaque elevation, >1mm; 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 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). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date.	Week 52
Adolescent Participants: Percentage of Participants Who Achieved PASI 75 Response at Week 52	Percentage of participants who achieved PASI 75 (>=75% improvement in PASI from baseline) response at Week 52 were 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 were 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. Baseline:closest measurement taken prior to or at time of first study drug administration date.	Week 52
Adolescent Participants: Percentage of Participants Who Achieved PASI 90 Response at Week 52	Percentage of participants who achieved PASI 90 (at least >=90% improvement in PASI from baseline) response at Week 52 were 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 were 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. Baseline: closest measurement taken prior to or at time of first study drug administration date.	Week 52
Number of Participants With Treatment-emergent Adverse Events (AEs)		From Week 0 up to Week 160
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)		From Week 0 up to Week 160

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Bissonnette R, Soung J, Hebert AA, Pink AE, Pinter A, Moore AY, Shi Y, Wang WH, Toth DP, Miller-Kassamali M, Cafone J, Jiang J, Li S, DeKlotz CMC, Nunes F, Lebwohl MG. Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents. N Engl J Med. 2025 Nov 6;393(18):1784-1795. doi: 10.1056/NEJMoa2504187.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): July 29, 2024
• Study Completion (Estimated): April 6, 2027

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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