A Long-term Extension Study of Ustekinumab in Pediatric Participants

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05092269
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Ustekinumab will be administered as a SC injection.

Study Details

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

Key Dates

Start date
Oct 18, 2021
Status verified
Jun 2026
Primary completion
Sep 29, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
159 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Ustekinumab
    Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 6 years and 4 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Center For Digestive Healthcare, LlcAtlantaGeorgia30342-
Mount SinaiNew YorkNew York10029-
Levine Childrens at Atrium HealthCharlotteNorth Carolina28207-
Pediatric Specialists Of VirginiaFairfaxVirginia22031-

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