Clinical trial NCT05083182: A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
Official title: A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Arthritis, Juvenile
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).


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

Primary outcomes:
measure: Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups
timeFrame: Week 28
measure: Cohort 2: Steady-state Trough Serum Concentration of Guselkumab at Week 28 by Baseline Age Groups
timeFrame: Week 28
measure: Cohort 1: Area Under the Curve at Steady-state (AUCss) Over a 12-Week Dosing Interval of Ustekinumab at Week 28 by Baseline Age Groups
timeFrame: Week 28
measure: Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 28 by Baseline Age Groups
timeFrame: Week 28
measure: Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24
timeFrame: Week 24
measure: Cohort 2: Percentage of Participants with jPsA Achieving ACR Pediatric 30 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Cohorts 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 52 by Baseline Age Groups
timeFrame: Week 52
measure: Cohorts 2: Steady-state Trough Serum Concentration of Guselkumabat at Week 52 by Baseline Age Groups
timeFrame: Week 52
measure: Cohort 1: AUCss Over a 12-Week Dosing Interval of Ustekinumab at Week 52 by Baseline Age Groups
timeFrame: Week 52
measure: Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 52 by Baseline Age Groups
timeFrame: Week 52
measure: Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 30 Response at Weeks 4, 8, 12, 16, and 52
timeFrame: Weeks 4, 8, 12, 16 and 52
measure: Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 50 and 70 Responses at Weeks 4, 8, 12, 16, 24, and 52
timeFrame: Weeks 4, 8, 12, 16, 24, and 52
measure: Cohorts 1 and 2: Time to Response Measured as Time to Achieving ACR Pediatric 30
timeFrame: Baseline, up to Week 24
measure: Cohorts 1 and 2: Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS) 10 at Weeks 4, 8, 12, 16, 24, and 52
timeFrame: Baseline, up to Weeks 4, 8, 12, 16, 24, and 52
measure: Cohorts 1 and 2: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52
timeFrame: Baseline, up to Weeks 4, 8, 12, 16, 24, and 52
measure: Cohorts 1 and 2: Change from Baseline in Psoriasis Area Severity Index (PASI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Cohorts 1 and 2: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 68
measure: Cohorts 1 and 2: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 68
measure: Cohorts 1 and 2: Percentage of Participants with Reasonably Related AEs
timeFrame: Up to Week 68
measure: Cohorts 1: Number of Participants with Antibodies to Ustekinumab
timeFrame: Weeks 52 and 68
measure: Cohorts 2 : Number of Participants with Antibodies to Guselkumab
timeFrame: Weeks 52 and 68
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Boston
country: United States
facility: Harvard Medical School - Boston Children's Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Legacy Emanuel Medical Center
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: STAT Research S A
city: Cordoba
country: Argentina
facility: Hospital de Ninos de Cordoba
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: Rosario
country: Argentina
facility: Instituto Caici
city: San Miguel De Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: Arhus
country: Denmark
facility: Aarhus Universitetshospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Caen
country: France
facility: CHU de Caen
city: Le Kremlin Bicêtre
country: France
facility: Hopital de Bicetre
city: Marseille
country: France
facility: Hopital Nord Marseille
city: Toulouse cedex 9
country: France
facility: CHU de Toulouse Hopital des Enfants
city: Vandoeuvre les Nancy
country: France
facility: Hôpital D'Enfants
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum
city: Hamburg
country: Germany
facility: Schon Klinik Hamburg Eilbek
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu
city: Lodz
country: Poland
facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej
city: Sosnowiec
country: Poland
facility: Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Umraniye Training and Research Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Staffordshire
country: United Kingdom
facility: Haywood Hospital
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: