A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504741-32-00

Acronym

78934804CRD2001

Enrollment

433

Registered

2024-05-22

Start date

2022-11-30

Completion date

Unknown

Last updated

2026-01-19

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 and endoscopic response at Week 48 compared with each monotherapy

Interventions

DRUGJNJ-78934804

DRUGPlacebo for Guselkumab

DRUGGolimumab and JNJ-78934804

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

DRUGGolimumab

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission and endoscopic response at Week 48 compared with each monotherapy	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden

Outcome results

None listed

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