Trial intelligence / Profile preview

Oral azacitidine plus best supportive care versus placebo plus best supportive care in lower-risk myelodysplastic syndrome

2022-500479-29-00Phase 3Authorised

Sponsor
Celgene Corporation
Start
Mar 2023
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
Countries
20
01

Overview

Phase 3, randomised, double-blind trial in myelodysplastic syndrome (MDS) comparing ONUREG plus best supportive care with Placebo plus best supportive care (2 arms). Primary endpoints: Safety and Complete remission within 6 cycles. Planned start Mar 2023; status: authorised.

02

Drugs

azacitidine
03

Conditions

myelodysplastic syndrome (MDS)

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