Abelacimab for Atrial Fibrillation

(LILAC-TIMI 76 Trial)

Recruiting in Palo Alto (17 mi)

+423 other locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Anthos Therapeutics, Inc.

Must not be taking: Vitamin K antagonists, DOACs

Disqualifiers: Acute reversible AF, Recent stroke, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing abelacimab, a medication aimed at preventing strokes and blood clots in people with Atrial Fibrillation. These patients are either unsuitable for or have chosen not to use common medications for thinning blood. Abelacimab works by reducing the blood's ability to form dangerous clots.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been on certain blood thinners like warfarin or other similar drugs in the last 60 days, you may not be eligible to participate.

Is Abelacimab safe for humans?

Abelacimab, also known as MAA868, is a new type of medication that targets specific proteins involved in blood clotting. While the research mentions its potential use in preventing blood clots, it does not provide specific safety data for humans in the available studies. ^{1 2 3 4 5}

How is the drug Abelacimab unique for treating atrial fibrillation?

Abelacimab is unique because it targets factor XI, a different part of the blood clotting process than other common treatments like apixaban, which target factor Xa. This novel approach may offer an alternative for patients who need anticoagulation therapy for atrial fibrillation. ^{3 6 7 8 9}

Research Team

Eligibility Criteria

This trial is for adults with Atrial Fibrillation who can't take oral anticoagulants. Participants must be 65-74 years old with a high stroke risk score or at least 75 with a slightly lower score, and have at least one bleeding risk factor. People who've had recent serious bleeds or strokes, AF from reversible causes, or used certain blood thinners recently cannot join.

Inclusion Criteria

I have been diagnosed with Atrial Fibrillation or flutter confirmed by an ECG.

I or my doctor think blood thinners taken by mouth aren't right for me.

I am 65-74 with a high stroke risk score or 75+ with a moderate stroke risk score.

Exclusion Criteria

I have a mechanical heart valve or need one due to my valve disease.

My atrial fibrillation is due to a temporary cause like surgery or untreated thyroid issues.

I have not had a brain or eye bleed in the last 3 months or any brain bleed without blood thinner treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abelacimab 150 mg subcutaneous or matching placebo once monthly

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Abelacimab (Monoclonal Antibodies)
• Placebo (Other)

Trial Overview The study tests abelacimab against a placebo to see if it lowers the chance of stroke or clots in patients unsuitable for standard blood thinner pills. It's designed to compare how well each treatment prevents these events without causing harmful side effects.

Participant Groups

Group I: Abelacimab (MAA868) Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Anthos Investigative Site 1060 Waco, TX

Anthos Investigative Site 9903 Houston, TX

Anthos Investigative Site 2015 Edmonton, Canada

Anthos Investigative Site 1044 Tamarac, FL

More Trial Locations

Who Is Running the Clinical Trial?

Anthos Therapeutics, Inc.

Lead Sponsor

Trials

6

Patients Recruited

6,600+

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa. [2023] Factor XI (FXI) inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of thromboembolic events. Abelacimab (MAA868) is a novel fully human monoclonal antibody that targets the catalytic domain and has dual activity against the inactive zymogen Factor XI and the activated FXI.

2. England pubmed.ncbi.nlm.nih.gov

ONO-7684 a novel oral FXIa inhibitor: Safety, tolerability, pharmacokinetics and pharmacodynamics in a first-in-human study. [2021] The objectives of this study were to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of ONO-7684, a novel activated factor XI (FXIa) inhibitor, in healthy subjects.

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of apixaban in the patients undergoing the ablation of atrial fibrillation. [2015] Apixaban, a factor Xa (FXa) inhibitor, is a new oral anticoagulant for stroke prevention in atrial fibrillation (AF). However, little is known about its efficacy and safety as a periprocedural anticoagulant therapy for patients who had undergone catheter ablation (CA) for AF.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of oral factor-Xa inhibitors versus Vitamin K antagonist in patients with non-valvular atrial fibrillation: Meta-analysis of phase II and III randomized controlled trials. [2017] Aim of our study was to assess the safety and efficacy on factor-Xa inhibitors (FXIs) in patients with non-valvular atrial fibrillation (NVAF) as compared to Vitamin K antagonist (VKA).

5. China pubmed.ncbi.nlm.nih.gov

Anti-FXa-IIa activity test in Asian and its potential role for drug adherence evaluation in patients with direct oral anticoagulants: a nationwide multi-center synchronization study. [2022] The data of anti-FXa-IIa activity detection in Asian population is insufficient, and its potential role for drug adherence evaluation in patients with direct oral anticoagulants (DOACs) remains unclear. This study carried out multi-center anti-FXa-IIa activity detection in Asian, aiming to explore its applicability in Asian population and find its role in adherence evaluation.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Monitoring of anti-Xa activity and factors related to bleeding events: A study in Japanese patients with nonvalvular atrial fibrillation receiving rivaroxaban. [2022] Anti-Xa activity (AXA) in patients with nonvalvular atrial fibrillation (NVAF) and relationship to bleeding events remains unclear.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Anti-factor Xa Activity Among Three Different Factor Xa Inhibitors in Non-valvular Atrial Fibrillation Patients with Renal Impairment. [2021] Factor-Xa inhibitors (FXaIs) are widely used for the treatment of non-valvular atrial fibrillation (NVAF). Although we have previously reported the distribution of the anti-factor Xa activity (AXA) values of three different FXaIs in NVAF patients, the differences in the distribution of AXA values among the different FXaIs in patients with renal impairment (RI) have not been fully elucidated.

8. United States pubmed.ncbi.nlm.nih.gov

Can Direct Oral Anticoagulants Be Used for Stroke Prevention Among Patients with Valvular Atrial Fibrillation? [2020] To review the clinical evidence underlying the efficacy and safety of the use of direct oral anticoagulants (DOACs) for the treatment of patients with valvular atrial fibrillation (AF).

9. Netherlands pubmed.ncbi.nlm.nih.gov

Apixaban for periprocedural anticoagulation during catheter ablation of atrial fibrillation: a systematic review and meta-analysis of 1691 patients. [2018] Apixaban, a direct factor Xa inhibitor recently approved for thromboembolic prophylaxis in patients with nonvalvular atrial fibrillation (AF), is increasingly used in patients undergoing catheter ablation of AF. However, large randomized studies supporting its use in the ablation context are still lacking. We undertook the present meta-analysis to assess the impact of apixaban in terms of thromboembolic and bleeding events in patients undergoing AF ablation as compared to warfarin.