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 Crohn’s Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504978-38-00

Acronym

CNTO1275CRD3004

Enrollment

Registered

2023-08-15

Start date

2021-03-16

Completion date

2025-03-03

Last updated

2024-09-24

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

Conditions

Moderately to Severely Active Crohn's Disease

Brief summary

Clinical remission at Induction Week 8 (Week I-8)

Interventions

DRUGSTELARA 130 mg concentrate for solution for infusion

DRUGPL2

DRUGPL1

DRUGSTELARA 90 mg solution for injection in pre-filled syringe

DRUGSTELARA 45 mg solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission at Induction Week 8 (Week I-8)	—

Countries

Belgium, Germany, Hungary, Poland

Outcome results

None listed

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