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

Arthritis, Juvenile Clinical Trial

— PSUMMIT-Jr  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083182
• Other study ID #: CR109101
• Secondary ID: 2020-005503-40CN
• Status: Recruiting
• Phase: Phase 3
• Start date: August 30, 2022
• Est. completion date: August 9, 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
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 9, 2027
• Est. primary completion date: November 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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-TNFa 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Psoriatic

Intervention

Drug:
• Ustekinumab
Ustekinumab will be administered as subcutaneous injection.
• Guselkumab
Guselkumab will be administered as subcutaneous injection.

Locations

Country	Name	City	State
Argentina	STAT Research S.A.	Ciudad Autonoma Buenos Aires
Argentina	Hospital de Ninos de Cordoba	Cordoba
Argentina	Instituto Medico Platense	La Plata
Argentina	Instituto Caici	Rosario
Argentina	Centro Medico Privado de Reumatologia	San Miguel De Tucuman
Denmark	Aarhus Universitetshospital	Arhus
Denmark	Odense Universitets Hospital	Odense
France	CHU de Caen	Caen
France	Hopital de Bicetre	Le Kremlin Bicêtre
France	Hopital Nord Marseille	Marseille
France	CHU de Toulouse Hopital des Enfants	Toulouse cedex 9
France	Hôpital D'Enfants	Vandoeuvre les Nancy
Germany	Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin
Germany	Schön Klinik Hamburg Eilbek	Hamburg
Germany	Asklepios Klinik Sankt Augustin	Sankt Augustin
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili	Brescia
Italy	Istituto Giannina Gaslini	Genova
Italy	Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO	Milano
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Poland	Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o	Sosnowiec
Poland	Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher	Warszawa
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp Reina Sofia	Cordoba
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Infanta Luisa	Sevilla
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Turkey	Hacettepe Universitesi Hastanesi	Ankara
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Umraniye Training and Research Hospital	Istanbul
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Sheffield Children's Hospital	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Haywood Hospital	Staffordshire
United States	Harvard Medical School - Boston Children's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Northwell Health	New York	New York
United States	Legacy Emanuel Medical Center	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Denmark,  France,  Germany,  Italy,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups	Steady-state trough serum concentration of ustekinumab at Week 28 by baseline age groups will be reported.	Week 28
Primary	Cohort 2: Steady-state Trough Serum Concentration of Guselkumab at Week 28 by Baseline Age Groups	Steady-state trough serum concentration of guselkumab at Week 28 by baseline age groups will be reported.	Week 28
Primary	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	AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 28 by baseline age groups.	Week 28
Primary	Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 28 by Baseline Age Groups	AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 28 by baseline age groups.	Week 28
Primary	Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24	Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30 percent (%) improvement (that is, a decrease in score) from baseline in greater than or equal to (>=) 3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: physician global assessment (PGA) of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by childhood health assessment questionnaire (CHAQ) and C-reactive protein (CRP).	Week 24
Primary	Cohort 2: Percentage of Participants with jPsA Achieving ACR Pediatric 30 Response at Week 24	Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in >=3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.	Week 24
Secondary	Cohorts 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 52 by Baseline Age Groups	Steady-state trough serum concentration of ustekinumab at Week 52 by baseline age groups will be reported.	Week 52
Secondary	Cohorts 2: Steady-state Trough Serum Concentration of Guselkumabat at Week 52 by Baseline Age Groups	Steady-state trough serum concentration of guselkumab at Week 52 by baseline age groups will be reported.	Week 52
Secondary	Cohort 1: AUCss Over a 12-Week Dosing Interval of Ustekinumab at Week 52 by Baseline Age Groups	AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 52 by baseline age groups.	Week 52
Secondary	Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 52 by Baseline Age Groups	AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 52 by baseline age groups.	Week 52
Secondary	Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 30 Response at Weeks 4, 8, 12, 16, and 52	The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in >=3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.	Weeks 4, 8, 12, 16 and 52
Secondary	Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 50 and 70 Responses at Weeks 4, 8, 12, 16, 24, and 52	The ACR pediatric 50 and 70 responses are defined as a 50% improvement or 70% improvement (that is, a decrease in score) from baseline in >=3 of the following 6 components, with worsening of >=30% in no more than 1 of the following components: 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.	Weeks 4, 8, 12, 16, 24, and 52
Secondary	Cohorts 1 and 2: Time to Response Measured as Time to Achieving ACR Pediatric 30	Time to response measured as time to achieving ACR pediatric 30 will be reported.	Baseline, up to Week 24
Secondary	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	Change from baseline in cJADAS 10 at Weeks 4, 8, 12, 16, 24, and 52 will be reported. The cJADAS is calculated as the sum of the scores of its 3 components: (1) physician global rating of overall disease activity, measured on a 10-cm horizontal visual analog scale; (2) parent/child ratings of well-being, assessed on a 10 cm horizontal line VAS; (3) number of active joints, assessed in 10 joints, for a total score ranging from 0 to 30 where 0=no activity and 30=maximum activity.	Baseline, up to Weeks 4, 8, 12, 16, 24, and 52
Secondary	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	Change from baseline in JADAS 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52 will be reported. The JADAS is calculated as the sum of the scores of its 4 components: (1) physician global rating of overall disease activity, measured on a 10-cm horizontal visual analog scale; (2) parent/child ratings of well-being, assessed on a 10 cm horizontal line VAS; (3) number of active joints, assessed in 71, 27, or 10 joints (for JADAS 71, JADAS 27, and JADAS 10, respectively); (4) CRP (truncated to 0-10 mg/dL).	Baseline, up to Weeks 4, 8, 12, 16, 24, and 52
Secondary	Cohorts 1 and 2: Change from Baseline in Psoriasis Area Severity Index (PASI) Score at Week 24	Change from baseline in PASI score at Week 24 among the participants with greater than or equal to (>=) 3% body surface area (BSA) psoriatic involvement and a PGA psoriasis score of >=2 (mild) at baseline will be reported. The PASI includes assessments of 4 areas of the body: the head and neck, the arms, the trunk, and the legs. The percentage of skin in each area affected by psoriasis is given a numeric score representing the proportion involved. The severity of the 3 plaque signs of erythema, thickness/induration, and desquamation/scaling, is assessed on a 5-point scale. The total PASI score is from 0-72, where 0=no disease and 72=more disease.	Baseline and Week 24
Secondary	Cohorts 1 and 2: Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to Week 68
Secondary	Cohorts 1 and 2: Percentage of Participants with Serious Adverse Events (SAEs)	A SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	Up to Week 68
Secondary	Cohorts 1 and 2: Percentage of Participants with Reasonably Related AEs	Percentage of participants with reasonably related AEs (including injection-site reactions and infections) will be reported.	Up to Week 68
Secondary	Cohorts 1: Number of Participants with Antibodies to Ustekinumab	Number of participants with antibodies to ustekinumab (including peak titers) will be reported.	Weeks 52 and 68
Secondary	Cohorts 2 : Number of Participants with Antibodies to Guselkumab	Number of participants with antibodies to guselkumab (including peak titers) will be reported.	Weeks 52 and 68