A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504977-19-00

Acronym

CNTO1275PUC3001

Enrollment

Registered

2023-08-03

Start date

2021-03-15

Completion date

2025-06-05

Last updated

2025-04-14

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

Brief summary

Clinical remission at Week I-8

Interventions

DRUGSTELARA 90 mg solution for injection in pre-filled syringe

DRUGSTELARA 130 mg concentrate for solution for infusion

DRUGPlacebo 1

DRUGSTELARA 45 mg solution for injection

DRUGPlacebo 2

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission at Week I-8	—

Countries

Belgium, Germany, Hungary, Poland

Outcome results

None listed

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