A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Study Purpose
The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention.
- - Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline.
- - Total psoriasis area and severity index (PASI) >=12 at screening and baseline.
- - Total investigator global assessment (IGA) >=3 at screening and baseline.
- - Candidate for phototherapy or systemic treatment for plaque psoriasis.
- - A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention.
Exclusion Criteria:
- - Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) - Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- - Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06095115 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
| Principal Investigator Affiliation | Janssen Research & Development, LLC |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Canada, China, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Spain, Taiwan, Turkey, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plaque Psoriasis |
Arms
Experimental: JNJ-77242113
Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have >=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of >=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156.
Experimental: Placebo
Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to receive JNJ-77242113 from Week 16 through Week 156.
Interventions
Drug: - JNJ-77242113
JNJ-77242113 will be administered orally.
Drug: - Placebo
Placebo will be administered orally
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Status
Address
Johnson Dermatology
Fort Smith, Arkansas, 72916
Status
Address
First OC Dermatology
Fountain Valley, California, 92708
Status
Address
Center for Dermatology Clinical Research
Fremont, California, 94538
Status
Address
Integrative Skin Science and Research
Sacramento, California, 95815
Status
Address
Rady Childrens Hospital San Diego
San Diego, California, 92123
Status
Address
Southern California Dermatology
Santa Ana, California, 92701
Status
Address
Clinical Science Institute
Santa Monica, California, 90404
Status
Address
Bioclinical Research Alliance Inc.
Miami, Florida, 33155
Status
Address
Ziaderm Research, LLC
North Miami Beach, Florida, 33162
Status
Address
Forcare Clinical Research Inc
Tampa, Florida, 33613
Status
Address
Skin Care Physicians of Georgia
Macon, Georgia, 31217
Status
Address
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Status
Address
Northshore Medical Group
Skokie, Illinois, 60077
Status
Address
Dundee Dermatology
West Dundee, Illinois, 60118
Status
Address
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Status
Address
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
Status
Address
Qualmedica Research
Owensboro, Kentucky, 42301
Status
Address
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, 70605
Status
Address
Allcutis Research
Beverly, Massachusetts, 01915
Status
Address
Michigan Center of Medical Research
Clarkston, Michigan, 48346
Status
Address
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Status
Address
Skin Specialists
Omaha, Nebraska, 68144
Status
Address
Allcutis Research
Portsmouth, New Hampshire, 03801
Status
Address
Windsor Dermatology
East Windsor, New Jersey, 08520
Status
Address
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Status
Address
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
Status
Address
Oakview Dermatology
Athens, Ohio, 45701
Status
Address
Optima Research
Boardman, Ohio, 44512
Status
Address
Wright State Physicians Health Center
Fairborn, Ohio, 45324
Status
Address
Central Sooner Research
Oklahoma City, Oklahoma, 73170
Status
Address
Oregon Medical Research Center
Portland, Oregon, 97201
Status
Address
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Status
Address
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
Status
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Address
Health Concepts
Rapid City, South Dakota, 57702
Status
Address
Arlington Research Center, Inc.
Arlington, Texas, 76011
Status
Address
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
Status
Address
Center for Clinical Studies
Houston, Texas, 77004
Status
Address
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Status
Address
Center for Clinical Studies
Webster, Texas, 77598
Status
Address
Springville Dermatology CCT Research
Springville, Utah, 84663
Status
Address
Virginia Dermatology Skin Cancer Center Pllc
Norfolk, Virginia, 23502
Status
Address
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, 98012
Status
Address
Premier Clinical Research
Spokane, Washington, 99202
International Sites
Status
Address
CINME Metabolic Research Center
Buenos Aires, , C1027AAP
Status
Address
Centro Privado de Medicina Familiar
Buenos Aires, , C1417EYG
Status
Address
Psoriahue
Caba, , C1425DKG
Status
Address
ARCIS Salud SRL Aprillus asistencia e investigacion
Ciudad Autonoma de Buenos Aires, , C1406AGA
Status
Address
Centro de Investigaciones Medicas Mar Del Plata
Mar Del Plata, , B7600FYK
Status
Address
Instituto De Especialidades De La Salud SRL
Rosario, , S2000DBS
Status
Address
MR Medicina Reumatologica
San Fernando Buenos Aires, , B1646
Status
Address
Dr Rodney Sinclair Pty Ltd
East Melbourne, , 3002
Status
Address
The Alfred Hospital
Melbourne, , 3004
Status
Address
Kingsway Dermatology & Aesthetics
Miranda, , 2228
Status
Address
ISHI dermatology
Mitcham, , 3132
Status
Address
Royal Melbourne Hospital
Parkville, , 3050
Status
Address
Veracity Clinical Research
Woolloongabba, , 4102
Status
Address
Dermatology Research Institute Inc.
Calgary, Alberta, T2J 7E1
Status
Address
Rejuvenation Dermatology Clinic Edmonton Downtown
Edmonton, Alberta, T5J 3S9
Status
Address
Dr. Chih-ho Hong Medical
Surrey, British Columbia, V3R 6A7
Status
Address
Mediprobe Research Inc.
London, Ontario, N5X 2P1
Status
Address
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, N6H 5L5
Status
Address
Dr. Sk Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
Status
Address
Canadian Dermatology Center
Toronto, Ontario, M3B 0A7
Status
Address
Toronto Research Centre
Toronto, Ontario, M3H 5Y8
Status
Address
FACET Dermatology
Toronto, Ontario, M4C 1L1
Status
Address
XLR8 Medical Research
Windsor, Ontario, N8T 1E6
Status
Address
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
Status
Address
China-Japan Friendship Hospital
Beijing, , 100013
Status
Address
Beijing Friendship Hospital Capital Medical University
Beijing, , 100050
Status
Address
Peking University Third Hospital
Beijing, , 100191
Status
Address
The Affiliated Hospital of Bengbu Medical College
Bengbu, , 233099
Status
Address
Hosp. of Chengde Medical University
Cheng De Shi, , 067030
Status
Address
Chengdu Second People's Hospital
Chengdu, , 610017
Status
Address
The First Hospital of Jiaxing
Jiaxing, , 314001
Status
Address
Qilu Hospital of Shandong University
Jinan, , 250012
Status
Address
Nanyang First People's Hospital
Nan Yang Shi, , 473004
Status
Address
Dermatology Hospital of Jiangxi Province
NanChang, , 330000
Status
Address
Shanghai skin disease hospital
Shanghai, , 200443
Status
Address
Northeast International Hospital
Shen Yang, , 110016
Status
Address
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , 430022
Status
Address
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , 710004
Status
Address
Affiliated Hospital of Jiangsu University
Zhenjiang, , 212001
Status
Address
Hopital Prive d'Antony
Antony, , 92160
Status
Address
Centre Hospitalier Victor Dupouy
Argenteuil, , 95107
Status
Address
Fachklinik Bad Bentheim
Bad Bentheim, , 48455
Status
Address
Charite - Campus Mitte
Berlin, , 10117
Status
Address
Universitatsklinikum Bonn
Bonn, , 53127
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Address
Klinische Forschung Dresden GmbH
Dresden, , 01069
Status
Address
Hautzentrum Dulmen
Dulmen, , 48249
Status
Address
Privatpraxis Dr. Hilton & Partner
Dusseldorf, , 40212
Status
Address
Universitaetsklinikum Frankfurt
Frankfurt am Main, , 60590
Status
Address
Universitaetsklinikum Freiburg
Freiburg, , 79104
Status
Address
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, , 88045
Status
Address
Universitaetsklinikum Heidelberg
Heidelberg, , 69120
Status
Address
Hautarztpraxis
Mahlow, , 15831
Status
Address
Universitaetsklinikum Muenster
Muenster, , 48149
Status
Address
Klinikum Oldenburg
Oldenburg, , 26133
Status
Address
Hautarztpraxis Mortazawi
Remscheid, , 42897
Status
Address
Universitaetsklinik Tuebingen
Tubingen, , 72076
Status
Address
Hautarztpraxis
Witten, , 58453
Status
Address
CentroDerm GmbH
Wuppertal, , 42287
Status
Address
Pecsi Tudomanyegyetem
Borgyogyaszati Klinika, , 7632
Status
Address
Obudai Egeszsegugyi Centrum Kft
Budapest, , 1036
Status
Address
Derma-B Kft
Debrecen, , 4031
Status
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Status
Address
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvar, , 7400
Status
Address
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
Szeged, , 6720
Status
Address
Allergo-Derm Bakos Kft.
Szolnok, , 5000
Status
Address
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprem, , 8200
Status
Address
Azienda Di Rilievo Nazionale E Di Alta Specializzazione
Palermo, , 90127
Status
Address
Azienda Ospedaliero Universitaria di Parma
Parma, , 43126
Status
Address
Policlinico Tor Vergata
Roma, , 00133
Status
Address
Istituto Clinico Humanitas
Rozzano, , 20089
Status
Address
Teikyo University Hospital
Itabashi Ku, , 173 8606
Status
Address
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, , 807-8556
Status
Address
Mito Kyodo General Hospital
Mito, , 310 0015
Status
Address
Nagoya City University Hospital
Nagoya, , 467 8602
Status
Address
Kindai University Hospital
Osaka Sayama shi, , 589 8511
Status
Address
Tohoku University Hospital
Sendai, , 980-8574
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Address
Tokyo Medical University Hospital
Shinjuku, , 160-0023
Status
Address
Mie University Hospital
Tsu, , 514 8507
Status
Address
Korea University Ansan Hospital
Ansan-si, , 15355
Status
Address
Chosun university hospital
Gwangju, , 61453
Status
Address
CHA Bundang Medical Center, CHA University
Gyeonggi-do, , 13496
Status
Address
Hallym University Sacred Heart Hospital
Gyeonggi-do, , 14068
Status
Address
Asan Medical Center
Seoul, , 05505
Status
Address
Specderm Poznanska sp j
Bialystok, , 15 375
Status
Address
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, , 15-351
Status
Address
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, , 82-300
Status
Address
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, , 30 002
Status
Address
Lidia Rajzer - Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny
Krakow, , 30-438
Status
Address
Centrum Medyczne Promed
Krakow, , 31-411
Status
Address
Dermed Centrum Medyczne Sp z o o
Lodz, , 90 265
Status
Address
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, , 90-338
Status
Address
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
Osielsko, , 86031
Status
Address
SOLUMED Centrum Medyczne
Poznan, , 60-529
Status
Address
Clinical Research Center sp z o o MEDIC R s k
Poznan, , 61 731
Status
Address
Przychodnia Specjalistyczna High Med
Warszawa, , 01-817
Status
Address
Klinika Ambroziak Dermatologia
Warszawa, , 02-953
Status
Address
DERMMEDICA Sp.z o.o.
Wroclaw, , 51 503
Status
Address
Centrum Medyczne Oporow
Wroclaw, , 52-416
Status
Address
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław, , 51-685
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Address
Hosp. Univ. Fundacion Alcorcon
Alcorcon, , 28922
Status
Address
Hosp. Gral. Univ. Dr. Balmis
Alicante, , 03010
Status
Address
Hosp. Clinic de Barcelona
Barcelona, , 08036
Status
Address
Hosp. de La Santa Creu I Sant Pau
Barcelona, , 08041
Status
Address
Hosp. Univ. de Basurto
Bilbao, , 48013
Status
Address
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, , 28006
Status
Address
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , 28007
Status
Address
Hosp. Univ. Son Espases
Palma de Mallorca, , 07120
Status
Address
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , 15706
Status
Address
Hosp. Virgen Macarena
Sevilla, , 41009
Status
Address
Hosp. de Manises
Valencia, , 46940
Status
Address
National Taiwan University Hospital Hsin-Chu Branch
Hsin Chu, , 30059
Status
Address
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, , 83301
Status
Address
National Taiwan University Hospital
Taipei, , 10048
Status
Address
Mackay Memorial Hospital
Taipei, , 10449
Status
Address
Taipei Veterans General Hospital
Taipei, , 11217
Status
Address
Linkou Chang Gung Memorial Hospital
Taoyuan, , 33382
Status
Address
Hacettepe University Medical Faculty
Ankara, , 06230
Status
Address
Gazi University Medical Faculty
Ankara, , 06560
Status
Address
Erciyes University Medical Faculty
Kayseri, , 38039
Status
Address
Ondokuz Mayis University
Samsun, , 55270
Status
Address
London North West University Healthcare NHS Trust
Harrow, , HA1 3UJ
Status
Address
Guy's and St Thomas' NHS Foundation Trust
London, , SE1 9RT
Status
Address
Royal Berkshire Hospital
Reading, , RG1 5AN
Status
Address
Salford Royal Hospital
Salford, , M6 8HD
