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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06143878
Other study ID # 77242113PSO3002
Secondary ID 77242113PSO3002
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 17, 2024
Est. completion date June 1, 2027

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date June 1, 2027
Est. primary completion date March 13, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
JNJ-77242113
JNJ-77242113 will be administered orally.
JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
Deucravacitinib
Deucravacitinib will be administered orally.
Deucravacitinib Matching Placebo
Deucravacitinib matching placebo will be administered orally.

Locations

Country Name City State
Argentina ARCIS Salud SRL Aprillus asistencia e investigacion Buenos Aires
Argentina Instituto Medico De Alta Complejidad (IMAC) Buenos Aires
Argentina Halitus Instituto Medico S.A. - Dermatologia y Estetica Caba
Argentina Hospital Italiano de Buenos Aires Caba
Argentina Instituto de Neumonologia y Dermatologia Caba
Argentina Hospital Italiano de La Plata La Plata
Argentina Instituto Caici Srl. Rosario
Argentina Centro de Investigaciones Medicas Tucuman San Miguel De Tucuman
Australia North Eastern Health Specialists Campbelltown
Australia Paratus Clinical Research Woden Canberra
Australia Sinclair Dermatology East Melbourne
Australia Skin Health Institute Inc. Melbourne
Australia Veracity Clinical Research Woolloongabba
Brazil Fundacao do ABC - Centro Universitario FMABC Santo Andre
Canada CCA Medical Research Corporation Ajax Ontario
Canada SimcoDerm Medical and Surgical Dermatology Centre Barrie Ontario
Canada Dermatrials Research Hamilton Ontario
Canada York Dermatology Clinic and Research Centre Richmond Hill Ontario
Canada Karma Clinical Trials Inc. St. John's Newfoundland and Labrador
Canada Enverus Medical Surrey British Columbia
Canada Alliance Clinical Trials Waterloo Ontario
Canada XLR8 Medical Research Windsor Ontario
Germany ISA - Interdisciplinary Study Association GmbH Berlin
Germany Hautarztpraxis Bramsche
Germany Klinische Forschung Dresden GmbH Dresden
Germany Praxis für Dermatologie und Venerologie Dresden
Germany Universitaetsklinikum Duesseldorf Duesseldorf
Germany MensingDerma research GmbH Hamburg
Germany Universitaetsklinikum Hamburg Eppendorf Hamburg
Germany Universitaetsklinikum Schleswig-Holstein Campus Kiel Kiel
Germany Studienzentrum Dr Schwarz Germany Langenau
Germany Universitatsklinikum Leipzig AOR Leipzig
Germany Universitatsklinikum Schleswig Holstein Campus Lubeck Lubeck
Germany Universitaetsklinikum Mannheim Mannheim
Germany Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein Munchen
Germany Hautarztpraxis Potsdam
Germany Universitaetsmedizin Rostock Rostock
Hungary Pecsi Tudomanyegyetem Borgyogyaszati Klinika
Hungary Obudai Egeszsegugyi Centrum Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Derma-B Kft Debrecen
Hungary Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika Szeged
Hungary Allergo-Derm Bakos Kft. Szolnok
Hungary Medmare Egeszsegugyi Es Szolgaltato Bt. Veszprem
Japan Fukuoka University Hospital Fukuoka
Japan Hino Dermatology Clinic Fukutsu
Japan Gifu University Hospital Gifu
Japan Gunma University Hospital Gunma
Japan Asahikawa Medical University Hospital Hokkaido
Japan JR Sapporo Hospital Hokkaido
Japan Tokai University Hospital Isehara
Japan Teikyo University Hospital Itabashi Ku
Japan St Marianna University Hospital Kawasaki City
Japan Hospital of the University of Occupational and Environmental Health Kitakyushu-shi
Japan Nagoya City University Hospital Nagoya
Japan University of the Ryukyus Hospital Nishihara
Japan Takagi Dermatology Clinic Obihiro shi
Japan Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital Osaka
Japan Kindai University Hospital Osaka Sayama shi
Japan Kume Clinic Sakai-shi
Japan Sapporo Skin Clinic Sapporo shi
Japan Tohoku University Hospital Sendai
Japan Osaka University Hospital Suita-shi
Japan Jitaikai Tachikawa dermatology clinic Tachikawa
Japan Shirasaki Dermatology Clinic Takaoka-shi
Japan Tokyo Medical University Hospital Tokyo
Japan Mie University Hospital Tsu
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Seoul National University Bundang Hospital Gyeonggi-do
Korea, Republic of Hanyang University Medical Center Seoul
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Poland Osteo-Medic s.c A. Racewicz, J Supronik Bialystok
Poland Specderm Poznanska sp j Bialystok
Poland Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska Elblag
Poland Centrum Medyczne dr Rajzer Sp z o o Krakow
Poland Centrum Medyczne Promed Krakow
Poland Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna Krakow
Poland Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna Lodz
Poland Dermed Centrum Medyczne Sp z o o Lodz
Poland DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c. Osielsko
Poland Clinical Research Center sp z o o MEDIC R s k Poznan
Poland SOLUMED Centrum Medyczne Poznan
Poland Klinika Ambroziak Dermatologia Warszawa
Poland Przychodnia Specjalistyczna High Med Warszawa
Poland Centrum Medyczne Oporow Wroclaw
Poland DERMMEDICA Sp.z o.o. Wroclaw
Poland WroMedica I.Bielicka, A.Strzalkowska s.c. Wroclaw
Spain Hosp. Gral. Univ. Dr. Balmis Alicante
Spain Hosp. Univ. de Cruces Barakaldo
Spain Hosp. de La Santa Creu I Sant Pau Barcelona
Spain Hosp. Univ. San Cecilio Granada
Spain Hosp. Univ. de Bellvitge L'Hospitalet de Llobregat
Spain Grupo Dermatologico Y Estetico Pedro Jaen Madrid
Spain Hosp. Gral. Univ. Gregorio Maranon Madrid
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Univ. de La Paz Madrid
Spain Hosp. Univ. de La Princesa Madrid
Spain Hosp. Univ. Infanta Leonor Madrid
Spain Hosp. Univ. I Politecni La Fe Valencia
Taiwan National Taiwan University Hospital Hsin Chu Branch Hsin Chu
Taiwan Chang Kung Memorial Hospital Kaohsiung City
Taiwan Taipei Medical University Shuang Ho Hospital New Taipei City
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Mackay Memorial Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan
United Kingdom Guy's and St Thomas' NHS Foundation Trust London
United Kingdom Royal Berkshire Hospital Reading
United Kingdom Salford Royal Hospital Salford
United Kingdom University Hospital Southampton NHS Foundation Trust Southampton
United States Hamilton Research, LLC. Alpharetta Georgia
United States David Fivenson MD, Dermatology Ann Arbor Michigan
United States Oakview Dermatology Athens Ohio
United States Optima Research Boardman Ohio
United States Tufts Medical Center Boston Massachusetts
United States Illinois Dermatology Institute - Chicago Loop Office Chicago Illinois
United States Michigan Center of Medical Research Clarkston Michigan
United States Driven Research LLC Coral Gables Florida
United States Modern Research Associates Dallas Texas
United States Henry Ford Medical Center Detroit Michigan
United States Windsor Dermatology East Windsor New Jersey
United States Hamzavi Dermatology Fort Gratiot Michigan
United States Johnson Dermatology Fort Smith Arkansas
United States First OC Dermatology Fountain Valley California
United States Center for Dermatology Clinical Research Fremont California
United States Schweiger Dermatology Group Hackensack New Jersey
United States Austin Institute for Clinical Research Houston Texas
United States Center for Clinical Studies Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Dermatology and Advanced Aesthetics Lake Charles Louisiana
United States Fife Dermatology Las Vegas Nevada
United States Dermatology Specialists Louisville Kentucky
United States Skin Care Physicians of Georgia Macon Georgia
United States Frontier Derm Partners CRO, LLC Mill Creek Washington
United States Ziaderm Research, LLC North Miami Beach Florida
United States Renstar Medical Research Ocala Florida
United States Central Sooner Research Oklahoma City Oklahoma
United States Skin Specialists Omaha Nebraska
United States Austin Institute for Clinical Research Pflugerville Texas
United States Medical Dermatology Specialists Phoenix Arizona
United States Indiana Clinical Trial Center Plainfield Indiana
United States Oregon Medical Research Center Portland Oregon
United States Allcutis Research Portsmouth New Hampshire
United States Health Concepts Rapid City South Dakota
United States National Clinical Research Richmond Virginia
United States Arlington Dermatology Rolling Meadows Illinois
United States Integrative Skin Science and Research Sacramento California
United States MediSearch Clinical Trials Saint Joseph Missouri
United States Progressive Clinical Research San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Southern California Dermatology Santa Ana California
United States Clinical Science Institute Santa Monica California
United States Center for Dermatology and Plastic Surgery Scottsdale Arizona
United States Northshore Medical Group Skokie Illinois
United States Premier Clinical Research Spokane Washington
United States Derm Research Center of New York, Inc. Stony Brook New York
United States Forcare Clinical Research Inc Tampa Florida
United States Center for Clinical Studies Webster Texas
United States Dundee Dermatology West Dundee Illinois
United States Wilmington Dermatology Center Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Germany,  Hungary,  Japan,  Korea, Republic of,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline to Week 16 Percentage of participants who achieve an IGA score of 0 or 1 and >=2-Grade improvement from baseline to Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Baseline and Week 16
Primary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16 Percentage of participants who achieve an IGA score of 0 at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to Weeks 4 and 16 Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 4 and 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline, Week 4, and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 90 Response at Week 8 Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Week 8 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and Week 8
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16 Percentage of participants achieving PASI 100 response (100% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement From Baseline at Week 16 Percentage of participants achieving ss-IGA score of 0 or 1 and >=2 grade improvement from baseline to Week 16 will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4). Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Signs Diary (PSSD) Symptom Score of 0 at Weeks 8 and 16 Percentage of participants achieving PSSD symptom score of 0 at Weeks 8 and 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Weeks 8 and 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving >=4 Point Improvement From Baseline in PSSD Itch Score at Weeks 4 and 16 Percentage of participants achieving >=4 Point improvement from baseline in PSSD itch score at Weeks 4 and 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Baseline, Week 4, and Week 16
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16 and 24 Percentage of participants who achieve an IGA score of 0 or 1 and >=2 grade improvement from baseline at Weeks 16 and 24 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Baseline, Week 16, and Week 24
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving an IGA Score of 0 at Weeks 16 and 24 Percentage of participants who achieve an IGA score of 0 at Weeks 16 and 24 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Weeks 16 and 24
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 75 Response at Weeks 16 and 24 Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 16 and 24 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline, Week 16 and Week 24
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 90 Response at Weeks 16 and 24 Percentage of participants achieving PASI 90 response (>=90% improvement in PASI from baseline) at Weeks 16 and 24 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline, Week 16, and Week 24
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PASI 100 Response at Weeks 16 and 24 Percentage of participants achieving PASI 100 response (100% improvement in PASI from baseline) at Weeks 16 and 24 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline, Week 16, and Week 24
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants With PSSD Symptom Score of 0 at Week 16 Percentage of participants achieving PSSD symptom score 0 at Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Week 16
Secondary Number of Participants with Adverse Events (AEs) An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Up to 165 weeks
Secondary Number of Participants with Serious Adverse Events (SAEs) SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important. Up to 165 weeks
Secondary Change From Baseline in Body Surface Area (BSA) at Week 16 Change from baseline in BSA at Week 16 will be reported. BSA is a commonly used measure of extent of skin disease. It is defined as the percentage of surface area of the body involved with the condition being assessed (that is, plaque psoriasis). Baseline and Week 16
Secondary Change from Baseline in PASI Total Score at Week 16 Change from baseline in PASI total score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas are assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and Week 16
Secondary Percent Improvement in PASI Score From Baseline at Week 16 Percent improvement in PASI score from Baseline at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline to Week 16 Percentage of participants achieving a sPGA-G Score of 0 or 1 and at least a 2-grade improvement from baseline to Week 16 will be reported. The sPGA-G is a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline to Week 16 Percentage of participants achieving a hf-PGA score of 0 or 1 and at least a 2-grade improvement from baseline to Week 16 will be reported. The hf-PGA assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3), and severe (4). Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percent Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 16 Percent change from baseline in mNAPSI score at Week 16 will be reported. The mNAPSI is an index used for assessing and grading the severity of nail psoriasis. Each of the participant's 10 fingernails are evaluated for 7 features. The first 3 features are each scored from 0 to 3 in severity and are (1) onycholysis and oil-drop dyschromia, (2) pitting, and (3) nail plate crumbling. The next 4 features are scored 0 - absent or 1 - present and are (1) leukonychia, (2) splinter hemorrhages, (3) nail bed hyperkeratosis, and (4) red spots in the lunula. The score ranges from 0 to 13 per nail and 0 to 130 for all fingernails. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percent of Participants Achieving Fingernail Physician's Global Assessment (f-PGA) Score of 0 or 1 at Week 16 Percent of participants achieving f-PGA score of 0 or 1 at Week 16 will be reported. The f-PGA is used to evaluate the current status of a participant's fingernail psoriasis on a scale of 0 to 4 (clear [0], minimal [1], mild [2], moderate [3], or severe [4]). Week 16
Secondary JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Symptom Score at Week 16 Change from baseline in PSSD symptom score at Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Change From Baseline in PSSD Sign Score at Week 16 Change from baseline in PSSD sign score at Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants With PSSD Sign Score of 0 at Week 16 Percentage of participants with PSSD sign score of 0 at Week 16 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 Score of 0 or 1 at Week 16 Percentage of participants achieving GenPs-SFQ Item 2 score of 0 or 1 at Week 16 will be reported. The GenPs-SFQ is a 2-item participant-reported instrument used to assess the impact of genital psoriasis on the frequency of sexual activity in the last 7 days. Item 1 assesses overall frequency of sexual activity in the last 7 days (none/zero, once, or 2 or more times), and item 2 assesses how frequently genital psoriasis symptoms have limited the frequency of sexual activity in the last 7 days (never [0], rarely [1], sometimes [2], often [3], or always [4]). Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 Percentage of participants achieving DLQI score of 0 or 1 at Week 16 will be reported. The DLQI is a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. Week 16
Secondary JNJ-77242113 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16 Change from baseline in total DLQI score at Week 16 will be reported. The DLQI is a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Change from Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16 Change from baseline in domain scores of the PROMIS-29 score at Week 16 will be reported. The PROMIS-29 is a 29-item generic HRQoL survey, assessing each of the 7 PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities) with 4 questions for each domain. The questions are ranked on a 5-point Likert scale. There is also a numerical rating scale that ranges from 0 (No pain) to 10 (Worst pain imaginable) for pain intensity. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores on anxiety, depression, fatigue, sleep disturbance, and pain interference indicate more severe symptoms. Higher scores on physical function and social participation indicate better health outcomes. Baseline and Week 16
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 16 and 24 Percentage of participants achieving DLQI score of 0 or 1 at Weeks 16 and 24 will be reported. The DLQI is a dermatology specific HRQoL instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. Weeks 16 and 24
Secondary JNJ-77242113 and Deucravacitinib Group: Percentage of Participants Achieving PSSD Symptom Score of 0 at Weeks 16 and 24 Percentage of participants achieving PSSD symptom score of 0 at Weeks 16 and 24 will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Weeks 16 and 24
Secondary Percentage of Participants Who Achieve PASI 75 Response After Week 24 Among PASI 75 Non-responders to Deucravacitinib at Week 24 Percentage of participants who achieve PASI 75 response (>=75% improvement in PASI) after Week 24 among PASI 75 Non-responders to deucravacitinib at Week 24 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and from Week 24 through Week 156
Secondary Percentage of Participants Who Achieve PASI 90 Response After Week 24 Among PASI 90 Non-responders to Deucravacitinib at Week 24 Percentage of participants who achieve PASI 90 response (>=90% improvement in PASI) after Week 24 among PASI 90 non-responders to deucravacitinib at Week 24 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and from Week 24 through Week 156
Secondary Percentage of Participants Achieving IGA Score of 0 or 1 after Week 24, Among Participants with IGA score >=2 at Week 24 in the Deucravacitinib Group Percentage of participants achieving IGA score of 0 or 1 after Week 24, among participants with IGA score >=2 at Week 24 in the deucravacitinib group will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). From Week 24 through Week 156
See also
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