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

Description

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

Study Overview

Study Details

Study overview

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).

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)

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

Condition
Arthritis, Juvenile
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Childrens Hospital Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

UCLA, Los Angeles, California, United States, 90095-3075

Boston

Harvard Medical School - Boston Children's Hospital, Boston, Massachusetts, United States, 02215-5450

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467-2403

New York

Northwell Health, New York, New York, United States, 11040

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27514

Portland

Legacy Emanuel Medical Center, Portland, Oregon, United States, 97227

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

5 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2027-08-09