A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504740-33-00

Acronym

CNTO1959CRD3005

Enrollment

190

Registered

2024-08-13

Start date

2022-11-22

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Fistulizing perianal Crohn's Disease

Brief summary

The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24

Interventions

DRUGGuselkumab- Solution for infusion- 10 mg/ml

DRUGPlacebo to Guselkumab

DRUGGuselkumab

DRUGPlacebo to Guselkumab- Solution for infusion- 10 mg/ml

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

DRUGPlacebo to Guselkumab 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
The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24	—

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

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