Trials / Active Not Recruiting

Active Not RecruitingNCT05083182

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

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)

Status: Active Not Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 50 (actual)

Sponsor: Janssen Research & Development, LLC · Industry
Sex: All
Age: 5 Years – 17 Years
Healthy volunteers: Not accepted

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).

Conditions

Arthritis, Juvenile

Interventions

Type	Name	Description
DRUG	Ustekinumab	Ustekinumab will be administered as subcutaneous injection.
DRUG	Guselkumab	Guselkumab will be administered as subcutaneous injection.

Timeline

Start date: 2022-08-30
Primary completion: 2026-01-12
Completion: 2026-12-05
First posted: 2021-10-19
Last updated: 2026-04-13

Locations

50 sites across 10 countries: United States, Argentina, Denmark, France, Germany, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05083182. Inclusion in this directory is not an endorsement.