A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502238-22-00

Acronym

CNTO1959PUC3001

Enrollment

Registered

2024-03-04

Start date

2024-05-14

Completion date

Unknown

Last updated

2026-01-11

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

Conditions

Ulcerative Colitis

Brief summary

Clinical remission (modified Mayo) at Week 56

Interventions

DRUGGuselkumab

DRUGGuselkumab 1 mL PFS Placebo

DRUGGuselkumab 2 mL PFS Placebo

DRUGGuselkumab 0.5 mL Varioject Placebo

DRUGGuselkumab - solution for injection in pre-filled syringe - 100 mg/mL

DRUGGuselkumab- Solution for infusion- 10 mg/ml

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission (modified Mayo) at Week 56	—

Countries

Belgium, Denmark, France, Italy, Norway, Poland, Portugal, Spain

Outcome results

None listed

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