Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC)

Sponsor

Anthos Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05712200

Collaborator

(none)

1,900

Enrollment

Locations

Arms

26.1

Anticipated Duration (Months)

633.3

Patients Per Site

24.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation (AF)	Biological: Abelacimab Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC)

Actual Study Start Date :

Dec 27, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abelacimab (MAA868) Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.	Biological: Abelacimab Abelacimab provided as liquid in vial (150 mg/mL) Other Names: MAA868
Placebo Comparator: Placebo Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.	Drug: Placebo Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab

Arm

Intervention/Treatment

Experimental: Abelacimab (MAA868)

Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Biological: Abelacimab

Abelacimab provided as liquid in vial (150 mg/mL)

Other Names:

MAA868

Placebo Comparator: Placebo

Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Drug: Placebo

Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab

Outcome Measures

Primary Outcome Measures

Efficacy: Time to first event of ischemic stroke or systemic embolism (SE) [Up to 30 months]
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding [Up to 30 months]

Secondary Outcome Measures

Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia [Up to 30 months]
Abelacimab versus placebo with regard to the composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event [Up to 30 months]
Efficacy: Cardiovascular (CV) mortality [Up to 30 months]
Efficacy: All-cause mortality [Up to 30 months]
Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding [Up to 30 months]
Abelacimab versus placebo with regard to net clinical outcome defined as the composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is able to understand and willing to provide written informed consent to participate in the trial
Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
Age 65-74 and a CHA2DS2VASc ≥5 OR age ≥75 and a CHA2DS2VASc ≥4
Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulation
At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls

Exclusion Criteria:

AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 60 days prior to randomization
Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study

Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anthos Investigative Site	Johns Creek	Georgia	United States	30024
2	Anthos Investigative Site	Charlotte	North Carolina	United States	28207
3	Anthos Investigative Site	Lenoir	North Carolina	United States	28638