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

Study acronym: BEXERA
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 9 more changesShow less
    • Recruitment opened
    • Trial sites expanded: 0 → 35 locations
    • Primary completion date: Nov 30, 2027 to Nov 2027
    • Study completion date: Dec 31, 2030 to Dec 2030
    • Start date: Oct 1, 2026 to Oct 2026
    • Interventions: Placebo (Drug), azacitidine (Drug), bexmarilimab (1mg/kg) (Drug), bexmarilimab (3mg/kg) (Drug) to Placebo (Drug), azacitidine (Drug), bexmarilimab (1mg/kg) (Drug), bexmarilimab (3mg/kg) (Drug)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 4 of 16 entries
    • Publications: details revised at 1 of 1 entry
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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
(from sponsor)		 Higher Risk Myelodysplastic Syndromes
Related terms Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov