Clinical Trial

Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes

Study acronym: BEXERA
Not Yet Recruiting Phase 2
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Summary
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with treatment-naïve higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomized to receive bexmarilimab at one of two dose levels (1 mg/kg or 3 mg/kg) plus azacitidine, or placebo plus azacitidine. The primary aim is to select the recommended dose of bexmarilimab for subsequent development based on a predefined integration of clinical response and safety/tolerability.
Trial Details
NCT Number NCT07672769
Lead Sponsor Faron Pharmaceuticals Ltd
Conditions Higher Risk Myelodysplastic Syndromes
Enrollment 90 participants
Start Date 2026-10-01
Primary Completion 2027-11-30 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-29