A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants with Moderately to Severely Active Crohn’s Disease with an Inadequate Response to Conventional Therapy

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508777-91-00

Acronym

IM047-023

Enrollment

Registered

2024-02-01

Start date

2023-05-16

Completion date

2024-09-13

Last updated

2024-10-07

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

Proportion of participants who achieve PCDAI < 10 at Week 64 Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point at Week 64

Detailed description

Proportion of participants who achieve PCDAI < 10 at Week 12

Interventions

DRUGZeposia 0.23 mg hard capsules Zeposia 0.46 mg hard capsules

DRUGZeposia 0.92 mg hard capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Proportion of participants who achieve PCDAI < 10 at Week 64 Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point at Week 64	—

Secondary

Measure	Time frame
Proportion of participants who achieve PCDAI < 10 at Week 12	—

Countries

Belgium, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

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