A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504718-31-00

Acronym

CNTO1959UCO3001

Enrollment

456

Registered

2024-07-10

Start date

2019-10-19

Completion date

Unknown

Last updated

2026-01-21

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 Response at Induction Week 12

Interventions

DRUGGuselkumab 1 mL PFS Placebo

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical Response at Induction Week 12	—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

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