NCT06196203

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

Conditions

• Higher-risk Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	AK117	AK117 IV injection
DRUG	Placebo	Placebo IV injection
DRUG	Azacitidine	Azacitidine SC injection

Timeline

• Start date: 2024-02-07
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2024-01-09
• Last updated: 2025-02-11

Locations

15 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study