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) - PSUMMIT-Jr

Janssen-Cilag International NV0 sites60 target enrollmentMarch 14, 2023

ConditionsJuvenile Psoriatic Arthritis MedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

DrugsSTELARA®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Juvenile Psoriatic Arthritis
Sponsor: Janssen-Cilag International NV
Enrollment: 60
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 14, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV

Eligibility Criteria

Inclusion Criteria

•1\. \=5 to \<18 years of age, inclusive.
•2\. Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made \=3 months (ie. 90 days) prior to screening. Arthritis plus psoriasis, or arthritis plus \=2 of the following: dactylitis, nail pits, family history of psioriasis in a first or second\-degree relative, psoriasis\-like rash.
•3\. Active disease in \=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.
•4\. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant’s source documents and initialed by the investigator.
•5\. Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•1\. Participants with enthesitis\-related arthritis (ERA; see definition in Appendix 17 of the study protocol)
•2\. Taken any disallowed therapies as noted in Section 6\.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention.
•3\. If participants were non\-responders to previously received IL\-23 blockers including guselkumab, tildrakizumab (MK3222\) and risankizumab (BI\-655066\). Prior non\-response to an anti\-TNFa inhibitor, an IL\-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion. Participants who previously discontinued ustekinumab for intolerance or inadequate response may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort. Participants who previously discontinued tildrakizumab or risankizumab due to intolerance may be enrolled into either cohort.
•4\. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4
•weeks or 5 half\-lives (whichever is longer) before the planned first dose of either study intervention or is currently enrolled in another study
•using an investigational intervention or procedure. Receipt of an investigational vaccine for COVID\-19 is not an automatic exclusion
•criterion; discuss with medical monitor.
•5\. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. An
•exception is made for participants currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent
•TB and documentation of having completed appropriate treatment for latent TB prior to the first administration of either study intervention