clinical trial · 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)
Bristol-Myers Squibb·phase3·active not recruiting·n = 230
Myelodysplastic SyndromesOral AzacitidinePlacebo for Oral Azacitidine
brief 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).
started
Dec 14, 2022
primary completion
Jul 31, 2028
completion
Jul 31, 2028
last updated
Feb 25, 2026
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol