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-TIMI 76) (LILAC-TIMI 76)

• ClinicalTrials.gov Identifier: NCT05712200
• Recruitment Status: Recruiting
• First Posted: February 3, 2023
• Last Update Posted: May 14, 2024
• Sponsor: Anthos Therapeutics, Inc.
• Information provided by (Responsible Party): Anthos Therapeutics, Inc.

Tracking Information

• First Submitted Date: January 12, 2023
• First Posted Date: February 3, 2023
• Last Update Posted Date: May 14, 2024
• Actual Study Start Date: December 27, 2022
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 25, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 25, 2023)

• Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia [ Time Frame: 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 [ Time Frame: Up to 30 months ]
• Efficacy: Cardiovascular (CV) mortality [ Time Frame: Up to 30 months ]
• Efficacy: All-cause mortality [ Time Frame: 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 [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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-TIMI 76)
• 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-TIMI 76)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Atrial Fibrillation (AF)

Intervention

• Biological: Abelacimab
  Abelacimab provided as liquid in vial (150 mg/mL)
  Other Name: MAA868
• Drug: Placebo

  Dosage Formulation: Liquid (in vial)

  Dose Strength: Placebo to Abelacimab

Study Arms

• Experimental: Abelacimab (MAA868)
  Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
  Intervention: Biological: Abelacimab
• Placebo Comparator: Placebo
  Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 25, 2023): 1900
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient is able to understand and has provided 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 ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
• Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
• 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
• Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study

Exclusion Criteria:

• AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
• Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Anthos Therapeutics; +1 617 430 6940; clinicaltrials@anthostherapeutics.com

• Listed Location Countries: Brazil, Bulgaria, Canada, Chile, China, Czechia, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Poland, Romania, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05712200
• Other Study ID Numbers: ANT-010; 2023-503224-66-00 ( EU Trial (CTIS) Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Anthos Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Anthos Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Anthos Therapeutics, Inc.
• Verification Date: May 2024