Psoriasis Clinical Trial

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and efficacy of ustekinumab and guselkumab in juvenile psoriatic arthritis (jPsA).

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Full Description

Juvenile psoriatic arthritis is a complex, chronic, progressive, debilitating musculoskeletal disease with significant remaining medical need. There is a need for medications which have a similar efficacy profile and a similar safety profile relative to currently available treatment for jPsA which include anti-tumor necrosis factor alpha (TNF alpha) inhibitors and secukinumab. STELARA (ustekinumab) is a fully human immunoglobulin G (IgG) 1 kappa monoclonal antibody (mAb) which binds with high affinity to the p40 subunit common to both interleukin (IL)-12 and IL 23 preventing IL-12/23p40 binding to the IL 12 Rb1 cell surface receptor shared by both cytokines. Through this mechanism of action, ustekinumab effectively neutralizes IL-12 T helper 1- and IL-23 T helper 17-mediated cellular responses. TREMFYA (guselkumab) is a fully human IgG1 lambda (G1 lambda) mAb that binds to the p19 subunit of human IL-23 with high affinity. The binding of guselkumab to IL-23 blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-specific intracellular signaling and subsequent activation and cytokine production. This study consists of Screening period (up to 6 weeks), Treatment period (up to 52 weeks) and a final safety visit at Week 68. The total duration of the study is up to 68 weeks.

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Eligibility Criteria

Inclusion Criteria:

Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made >=3 months (that is, 90 days) prior to screening
Active disease in at least greater than or equal to (>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period

Exclusion Criteria:

Participants with enthesitis-related arthritis (ERA)
Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
Have a history of, or ongoing, chronic or recurrent infectious disease
Has evidence of herpes zoster infection within 8 weeks prior to Week 0
Have a known history of hepatitis C infection or test positive at screening

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT05083182

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 37 Locations for this study

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Childrens Hospital Los Angeles
Los Angeles California, 90027, United States
Harvard Medical School - Boston Children's Hospital
Boston Massachusetts, 02215, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Northwell Health
New York New York, 11040, United States
University of North Carolina
Chapel Hill North Carolina, 27514, United States
Legacy Emanuel Medical Center
Portland Oregon, 97227, United States
University of Utah
Salt Lake City Utah, 84132, United States
STAT Research S.A.
Ciudad Autonoma Buenos Aires , C1013, Argentina
Hospital de Ninos de Cordoba
Cordoba , 5000, Argentina
Instituto Medico Platense
La Plata , B1900, Argentina
Centro Medico Privado de Reumatologia
San Miguel De Tucuman , T4000, Argentina
Aarhus Universitetshospital
Arhus , 8200, Denmark
CHU de Caen
Caen , 14033, France
Hopital de Bicetre
Le Kremlin Bicêtre , 94270, France
Hopital Nord - Marseille
Marseille , 13015, France
CHU de Toulouse Hopital des Enfants
Toulouse cedex 9 , 31059, France
Hôpital D'Enfants
Vandoeuvre les Nancy , 54511, France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin , 13353, Germany
Schön Klinik Hamburg Eilbek
Hamburg , 22081, Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin , 53757, Germany
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia , 25100, Italy
Istituto Giannina Gaslini
Genova , 16147, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milano , 20122, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec , 41-20, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warszawa , 02-63, Poland
Hosp. de La Santa Creu I Sant Pau
Barcelona , 8041, Spain
Hosp. Reina Sofia
Cordoba , 14004, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela , 15706, Spain
Hosp. Infanta Luisa
Sevilla , 41010, Spain
Hosp. Univ. I Politecni La Fe
Valencia , 46026, Spain
Hacettepe Universitesi Hastanesi
Ankara , 6230, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Umraniye Training and Research Hospital
Istanbul , 34766, Turkey
Great Ormond Street Hospital
London , WC1N , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne , NE1 4, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , NG7 2, United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT05083182

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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