A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504735-41-00

Acronym

CNTO1959PBCRD3007

Enrollment

Registered

2024-08-13

Start date

2024-03-05

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

Clinical remission at Week 52 (defined as PCDAI score ≤10), Endoscopic response (≥50% reduction from SES-CD score at baseline) at Week 52

Interventions

DRUGPlacebo 2.0ml equivalent

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

DRUGPlacebo 1.0ml equivalent

DRUGPlacebo 0.5ml equivalent

DRUGGuselkumab

DRUGGuselkumab- Solution for infusion- 10 mg/ml

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission at Week 52 (defined as PCDAI score ≤10), Endoscopic response (≥50% reduction from SES-CD score at baseline) at Week 52	—

Countries

Austria, Belgium, France, Italy, Netherlands, Norway, Poland, Portugal, Spain

Outcome results

None listed

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