Bristol-Myers Squibb Company — Zeposia EMA EPAR variation assessment report (EMEA/H/C/004835, 2020)
Bristol-Myers Squibb Company · 2020 · EMA EPAR variation assessment report · company profile →
Report summary
This report assesses the premature termination of pediatric study IM047023 for Zeposia (ozanimod) in Crohn's disease, submitted under Article 46 of Regulation (EC) No 1901/2006. The Phase 2/3 study, designed to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics in pediatric patients, was halted by Bristol-Myers Squibb. The termination was not due to safety concerns but rather the failure of an adult Crohn's disease study to meet its primary endpoint. Only 5 of 120 planned subjects were randomized and treated, and none reached the primary endpoints before the study concluded.
Key findings — cited to the page
| Subjects in 0.46 mg/day group (Cohort 1) | 3 subjects | Study IM047023 · p.5 |
| Procedure number | EMA/PAM/0000263324 | Zeposia · p.1 |
| Related serious TEAEs (0.46 mg group) | 0 | Study IM047023 · p.11 |
| Study phase | Phase 2/3 | Study IM047023 · p.4 |
| Serious TEAEs (0.92 mg group) | 1 | Study IM047023 · p.11 |
| Actual enrollment | 12 subjects | Study IM047023 · p.5 |
| Randomized and treated subjects | 5 subjects | Study IM047023 · p.5 |
| Treatment period duration | 64 weeks | Study IM047023 · p.5 |
| Induction period duration | 12 weeks | Study IM047023 · p.5 |
| Maintenance period duration | 52 weeks | Study IM047023 · p.5 |
| LTE period duration | 4.5 years | Study IM047023 · p.5 |
| Subjects randomized and treated in Cohort 1 (0.46 mg/day group) | 3 subjects | Study IM047023 · p.5 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →