Plaque Psoriasis Clinical Trial
Official title:
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States, Argentina, Australia, Brazil, Canada, Germany, Hungary, Japan, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01194219 -
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis
|
Phase 3 | |
Recruiting |
NCT06030076 -
A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
|
||
Completed |
NCT04263610 -
Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
|
Phase 4 | |
Completed |
NCT02601469 -
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT05600036 -
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
Completed |
NCT03614078 -
A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
|
Phase 2 | |
Not yet recruiting |
NCT05036889 -
A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.
|
N/A | |
Completed |
NCT04603027 -
A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT03638258 -
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT02881346 -
Efficacy and Tolerability of Enstilar® in Daily Practice
|
||
Recruiting |
NCT02611349 -
Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
|
Phase 3 | |
Completed |
NCT02251678 -
Evaluate the Effect of Elimune Capsules
|
Phase 1 | |
Completed |
NCT01987843 -
Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
|
Phase 2 | |
Terminated |
NCT01708629 -
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
|
Phase 3 | |
Withdrawn |
NCT00747032 -
To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
|
Phase 3 | |
Completed |
NCT01230138 -
Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
Completed |
NCT00581100 -
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
|
Phase 4 | |
Suspended |
NCT01228656 -
Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate
|
Phase 2 | |
Completed |
NCT00540618 -
A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis
|
Phase 2 |