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MAA868 dose-finding study in atrial fibrillation
NCT04213807Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2019
- Primary completion
- Dec 2020
- Countries
- 1
- Sponsor
- Anthos Therapeutics
- Modality
- Monoclonal Antibodies
- Drugs
- abelacimab
- Conditions
- Atrial fibrillation (AFib)atrial flutter (AFL)
01
Overview
Phase 2, randomised, double-blind trial of abelacimab in Atrial fibrillation (AFib) and atrial flutter (AFL) (4 arms), sponsored by Anthos Therapeutics. Primary endpoint: Proportion of participants achieving >= 50%, 80%, and 90% Factor XI Inhibition at Day 91. Started Dec 2019; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
MAA868 Low Dose
Monthly SC injection of MAA868 (Low Dose)
MAA868 High Dose
Monthly SC injection of MAA868 (High Dose)
MAA868 Dose TBD
Monthly SC injection of MAA868 (Dose TBD)
Placebo
Monthly SC injection of Placebo
03
Who it enrols
Patients with paroxysmal atrial fibrillation or flutter at low risk of stroke (CHA2DS2-VASc 0-1 for men, 1-2 for women) for whom anticoagulation is not indicated.
04
Endpoints
Primary
Proportion of participants achieving >= 50%, 80%, and 90% Factor XI Inhibition
Secondary
Proportion of participants achieving >= 50%, 80%, and 90% Factor XI Inhibition (Early)
Overall Number of Participants Who Experienced Adverse Events
Incidence of Major Bleeding, Clinically Relevant Non-major Bleeding, and Total Bleeding
Immunogenicity of MAA868
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