A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
← catalyst calendarNCT05469737 · readout in 712 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
230estimated
Sites
65
Countries
Argentina, Australia, Canada +14
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
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-14 | actual | When the study began enrolling |
| Primary completion | 2028-07-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-07-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-07-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelodysplastic Syndromes
Interventions
- Drug: Oral Azacitidine — also filed as BMS-986345, Oral-Aza, ONUREG®
- Drug: Placebo for Oral Azacitidine
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
measured 6 cycles plus 28 days (up to 24 weeks)
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
measured Up to 24 weeks
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