ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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)

Quick Facts

Study Start:2022-08-30

Study Completion:2027-08-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05083182

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.

Ages Eligible for Study:5 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

Childrens Hospital Los Angeles

Los Angeles, California, 90027

United States

UCLA

Los Angeles, California, 90095-3075

United States

Harvard Medical School - Boston Children's Hospital

Boston, Massachusetts, 02215-5450

United States

Northwell Health

New York, New York, 11040

United States

Montefiore Medical Center

The Bronx, New York, 10467-2403

United States

University of North Carolina

Chapel Hill, North Carolina, 27514

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Legacy Emanuel Medical Center

Portland, Oregon, 97227

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30

Study Completion Date2027-08-09

Study Record Updates

Study Start Date2022-08-30

Study Completion Date2027-08-09

Terms related to this study

Additional Relevant MeSH Terms

Arthritis, Juvenile