A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504719-34-00

Acronym

CNTO1959UCO3004

Enrollment

143

Registered

2024-06-18

Start date

2023-02-21

Completion date

Unknown

Last updated

2026-01-13

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

Conditions

Moderate to Severly Active Ulcerative Colitis

Brief summary

Clinical remission (at week 12)

Interventions

DRUGGuselkumab

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

DRUGGuselkumab 1 mL PFS Placebo

DRUGGuselkumab 2 mL PFS Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical remission (at week 12)	—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Hungary, Poland, Slovakia, Spain

Outcome results

None listed

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