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A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501067-40-00
Acronym
CNTO1275ISD3001
Enrollment
83
Registered
2023-03-31
Start date
2021-11-30
Completion date
Unknown
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Ulcerative Colitis, Moderately to Severely Active Crohn's Disease, Juvenile Psoriatic Arthritis

Brief summary

AEs, SAEs, AEs leading to discontinuation of study intervention, and AEs of special interest (as determined for each indication)., Clinical laboratory hematology and chemistry., Injection-site reactions, AEs of worsening of the disease under study., An addition of concomitant therapy due to loss of response.

Interventions

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
AEs, SAEs, AEs leading to discontinuation of study intervention, and AEs of special interest (as determined for each indication)., Clinical laboratory hematology and chemistry., Injection-site reactions, AEs of worsening of the disease under study., An addition of concomitant therapy due to loss of response.

Countries

Belgium, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026