A Lactation Study in Women Receiving Treatment With Ozanimod
← catalyst calendarNCT06181630 · readout in 119 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 4
Status
Withdrawn
Study type
Interventional
Design
Na · None · Treatment
Enrollment
0actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Replaced with another clinical trial
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-11-15 | estimated | When the study began enrolling |
| Primary completion | 2026-12-16 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-16 | estimated | The whole study's end, after follow-up |
| First posted | 2023-12-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Lactating Women
- Breastfed Infants
Intervention
- Diagnostic test: Breast milk, plasma, and blood samples
Primary outcomes
what the primary-completion date above is the date OFAverage concentration at steady state (Css-avg) in breast milk
measured Predose; Up to 24 hours post dose
Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk
measured Predose; Up to 24 hours post dose
Drug daily infant dose
measured Predose; Up to 24 hours post dose
Drug relative infant dose
measured Predose; Up to 24 hours post dose
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