NCT05469737

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)

A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Oral Azacitidine	Specified dose on specified days
DRUG	Placebo for Oral Azacitidine	Specified dose on specified days

Timeline

• Start date: 2022-12-14
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2022-07-22
• Last updated: 2026-02-25

Locations

65 sites across 17 countries: United States, Argentina, Australia, Canada, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan, Poland, South Korea, Spain, Sweden

Regulatory

• FDA-regulated drug study