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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06220604
Other study ID # 77242113PSO3004
Secondary ID 77242113PSO3004
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 9, 2024
Est. completion date September 20, 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 evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.


Recruitment information / eligibility

Status Recruiting
Enrollment 675
Est. completion date September 20, 2027
Est. primary completion date February 10, 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
Australia The Skin Centre Benowa
Australia Monash Medical Centre Clayton
Australia Premier Specialists Kogarah
Australia The Alfred Hospital Melbourne
Australia ISHI dermatology Mitcham
Australia Royal Melbourne Hospital Parkville
Brazil UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu
Brazil Chronos Clinica Medica LTDA - Chronos Pesquisa Clinica Brasilia
Brazil Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP Ribeirao Preto
Brazil Fundacao do ABC - Centro Universitario FMABC Santo Andre
Brazil Fundacao Faculdade Regional De Medicina S J Rio Preto Hospital De Bas Sao Jose do Rio Preto
Brazil Hospital Das Clinicas Da Faculdade De Medicina Da USP Sao Paulo
Canada Lovegrove Dermatology London Ontario
Canada Lynderm Research Inc. Markham Ontario
Canada DermEdge Research Mississauga Ontario
Canada Innovaderm Research Inc. Montreal Quebec
Canada Skin Centre for Dermatology Peterborough Ontario
Canada Centre De Recherche Dermatologique Du Quebec Metropolitain Quebec
Canada Dr. Chih-ho Hong Medical Surrey British Columbia
Canada North York Research Inc Toronto Ontario
Canada Toronto Research Centre Toronto Ontario
Canada XLR8 Medical Research Windsor Ontario
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
Germany Hautarztpraxis Dr. Mihaescu Augsburg
Germany Fachklinik Bad Bentheim Bad Bentheim
Germany CRS Clinical Research Services Berlin GmbH Berlin
Germany Niesmann & Othlinghaus GbR Bochum
Germany Klinikum Darmstadt GmbH - Hautklinik Darmstadt
Germany Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden Dresden
Germany Hautzentrum Dulmen Dulmen
Germany Privatpraxis Dr. Hilton & Partner Dusseldorf
Germany Derma-Study-Center Friedrichshafen GmbH Friedrichshafen
Germany Eurofins bioskin GmbH Hamburg
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany Hautarztpraxis Mahlow
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Germany Hautmedizin Saar Merzig
Germany Universitaetsklinikum Muenster Muenster
Germany Klinikum Oldenburg Oldenburg
Germany Hautarztpraxis Witten
Germany CentroDerm GmbH Wuppertal
Hungary Uno Medical Trials Ltd. Budapest
Hungary Bugat Pal Korhaz Gyongyos
Hungary Synexus Magyarorszag Kft Gyula
Hungary Bacs Kiskun Varmegyei Oktatokorhaz Kecskemet
Hungary Synexus Magyarorszag Kft Zalaegerszeg
Korea, Republic of Korea University Ansan Hospital Ansan-si
Korea, Republic of Hallym University Sacred Heart Hospital Anyang-si
Korea, Republic of The Catholic University of Korea Bucheon St Mary s Hospital Bucheon si
Korea, Republic of Chosun university hospital Gwangju
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Poland Renew Clinic Bialystok
Poland Care Clinic Katowice
Poland Centrum Medyczne Angelius Provita Katowice
Poland Prywatny Gabinet Dermatologiczny Elzbieta Klujszo Kielce
Poland Diamond Clinic Krakow
Poland Jagiellonskie Centrum Innowacji Krakow
Poland Krakowskie Centrum Badan Klinicznych Krakow
Poland SGD s.c. Krakow
Poland Etyka Osrodek Badan Klinicznych Olsztyn
Poland Royalderm Agnieszka Nawrocka Warsaw
Poland Carpe Diem Centrum Medycyny Estetycznej Warszawa
Poland Synexus Polska Sp z o o Oddzial w Warszawie Warszawa
Poland WroMedica I.Bielicka, A.Strzalkowska s.c. Wroclaw
Romania Cabinet Medical Dermato-Venerologie Cluj-Napoca
Romania Centrul Medical Vitaplus Craiova
Romania Spitalul Clinic Judetean de Urgenta Craiova
Romania Sc Iasiprest Srl Iasi
Romania Spitalul Clinic Judetean de Urgenta Bihor Oradea
Romania Spitalul Clinic Judetean Mures Targu Mures
Romania New Derm Clinic Timisoara
Spain Hosp. Univ. Fundacion Alcorcon Alcorcon
Spain Hosp. Univ. Germans Trias I Pujol Badalona
Spain Hosp Clinic de Barcelona Barcelona
Spain Hosp. de Manises Manises
Spain Hosp Clinico Univ de Salamanca Salamanca
Spain Clinica Gaias Santiago de Compostela
Spain Hosp. Clinico Univ. de Santiago Santiago de Compostela
Spain Hosp. Ntra. Sra. de Valme Sevilla
Spain Hosp. Virgen Macarena Sevilla
Spain Hosp. de La Marina Baixa Villajoyosa
Spain Hosp. Clinico Univ. Lozano Blesa Zaragoza
Taiwan Kaohsiung Medical University Chung Ho Memorial Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Chung Shan Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Taipei Medical University Taipei
Taiwan Taipei Municipal Wanfang Hospital Taipei
United States University of Michigan Ann Arbor Michigan
United States Arlington Research Center, Inc. Arlington Texas
United States Great Lakes Research Group Bay City Michigan
United States Bexley dermatology research Bexley Ohio
United States Cope Family Medicine - Ogden Clinic Bountiful Utah
United States Metro Boston Clinical Partners Brighton Massachusetts
United States The Derm Institute of West Michigan Caledonia Michigan
United States Hamzavi Dermatology Canton Michigan
United States Clinical Research Center of the Carolinas LLC Charleston South Carolina
United States UT Southwestern Medical Center Dallas Texas
United States Southeast Dermatology Specialists Douglasville Georgia
United States California Dermatology & Clinical Research Institute Encinitas California
United States T Joseph Raoof Md Inc Encino California
United States UCSF Fresno Fresno California
United States Palmetto Clinical Trial Services, LLC Greenville South Carolina
United States Cleaver Dermatology Kirksville Missouri
United States University of California Los Angeles Los Angeles California
United States Wallace Medical Group, Inc. Los Angeles California
United States Skin Sciences, PLLC Louisville Kentucky
United States ActivMed Practices and Research Methuen Massachusetts
United States Bioclinical Research Alliance Inc. Miami Florida
United States Miami Dermatology And Laser Institute Miami Florida
United States Virginia Dermatology Skin Cancer Center Pllc Norfolk Virginia
United States Dermatologist Medical Group of North County, Inc. Oceanside California
United States Qualmedica Research Owensboro Kentucky
United States Paddington Testing Co, Inc. Philadelphia Pennsylvania
United States Alliance Dermatology and MOHS Center P C Phoenix Arizona
United States Oregon Dermatology & Research Center Portland Oregon
United States DermAssociates, PC Rockville Maryland
United States Arlington Dermatology Rolling Meadows Illinois
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Springville Dermatology CCT Research Springville Utah
United States Forcare Clinical Research Inc Tampa Florida
United States Somerset Skin Centre Troy Michigan
United States Essential Medical Research Tulsa Oklahoma
United States Center for Clinical Studies Webster Texas
United States Kalo Clinical Research West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Germany,  Hungary,  Korea, Republic of,  Poland,  Romania,  Spain,  Taiwan, 

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 at Week 16 Percentage of participants achieving an IGA score of 0 or 1 and >=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Baseline and Week 16
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 achieving an IGA Score of 0 at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4) Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16 Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Weeks 4 and 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline, Weeks 4 and 16
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 a >=2-grade Improvement From Baseline at Week 16 Percentage of participants achieving ss-IGA score of 0 or 1 and a >=2-grade improvement from baseline at Week 16 will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4). Baseline and Week 16
Secondary JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Weeks 8 and 16 Percentage of participants achieving PSSD symptoms score of 0 at Weeks 8 and 16 will be reported. The PSSD is a self-administered patient-reported outcome (PRO) instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Weeks 8 and 16
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 is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Baseline, Weeks 4 and 16
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, Weeks 16 and 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, Weeks 16 and 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, Weeks 16 and 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) at Weeks 16 and 24 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Weeks 16 and 24
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 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 Score at Week 16 Change from baseline in PASI score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas are assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. Baseline and Week 16
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 >=2-grade Improvement From Baseline to Week 16 Percentage of participants achieving a sPGA-G Score of 0 or 1 and >=2-grade improvement from baseline to Week 16 will be reported. The sPGA-G is a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Baseline and Week 16
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 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 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 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) Total Score of 0 or 1 at Week 16 Percentage of participants achieving DLQI total score of 0 or 1 at Week 16 will be reported. The DLQI is a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It is a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The total score ranges from 0 to 30 with a higher score indicating greater impact on HRQoL. Week 16
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 Week 24 Percentage of participants achieving PSSD symptom score of 0 at Week 24 will be reported. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. Week 24
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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