A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation

Anthos Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Biological: MAA868 Cohort 2; Biological: MAA868 Cohort 1; Other: Placebo; Biological: MAA868 Cohort 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT04213807

ANT-004

Details and patient eligibility

About

This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.

Enrollment: 28 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients ≥ 18 and < 85 years old with paroxysmal atrial fibrillation (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or
• Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory [e.g. Holter] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this.
• Patients with a Congestive heart failure, Hypertension, Age ( > 65 = 1 point, > 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated

Exclusion criteria

• History of stroke, transient ischemic attack or systemic embolism
• History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
• History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
• Known bleeding diathesis or any known active bleeding site at screening or baseline
• Family history of bleeding disorder
• Known active GI lesions predisposing to bleeding events
• Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period
• Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area <1.5 cm2)
• Patients with a prosthetic heart valve

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

MAA868

Experimental group

Description:

Subcutaneous injection on Day 1 with two subsequent monthly injections

Treatment:

Biological: MAA868 Cohort 2

Biological: MAA868 Cohort 1

Biological: MAA868 Cohort 3

Placebo

Placebo Comparator group

Description:

Subcutaneous injection: Placebo on Day 1 with two subsequent monthly injections

Treatment:

Other: Placebo