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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504736-18-00

Acronym

CNTO1959CRD3001

Enrollment

474

Registered

2024-08-01

Start date

2018-07-26

Completion date

Unknown

Last updated

2026-01-23

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

Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12, Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12

Interventions

DRUGGuselkumab

DRUGSTELARA 90 mg solution for injection in pre-filled syringe

DRUGSTELARA 130 mg concentrate for solution for infusion

DRUGPlacebo for Ustekimumab

DRUGPlacebo for Guselkumab

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
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12, Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12	—

Countries

Belgium, Croatia, Czechia, France, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

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