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)

July 28, 2026 updated by: Novartis Pharmaceuticals

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)

This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who provide consent, will need to complete the end of treatment visit (EoT) assessments of the Core Part of CMAA868A2302 (ANT-010/NCT05712200) prior to receiving first dose in the OLE. Day 1 visit or dosing should occur on same day as EoT visit to avoid treatment interruption.

Participation in OLE will end if a patient permanently discontinues study treatment, or the study is completed or terminated by the Sponsor.

All patients will need to complete End of Study in Extension visit in person followed by a phone call visit 30 days after End of Extension visit. Any updates in AE or concomitant medications will be reported by a phone call/video call visit.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients are able to provide written informed consent to enter the extension part.
  • Patients must be on study treatment at the time of EoT visit in the core part.

Exclusion Criteria:

  • Patients meeting any exclusion criteria in the core part.
  • Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation
  • History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes
  • Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study.

Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abelacimab (MAA868)
abelacimab 150 mg subcutaneous (SC)
Biological: Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Other Names:
  • MAA868

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first ISTH major Bleeding events
Time Frame: Up to 3 years
Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
Up to 3 years
Time to first BARC type 3c/5 bleeding
Time Frame: Up to 3 years
Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Up to 3 years
Number of participants with ISTH major or CRNM bleeding
Time Frame: Up to 3 years
Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
Up to 3 years
Number of participants with bleeding
Time Frame: Up to 3 years
All suspected bleeding events either reported by the patient or observed by the Investigator
Up to 3 years
Number of participants with TEAEs and TESAEs
Time Frame: Up to 3 years
Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
Up to 3 years
Number of participants with treatment discontinuations due to TEAEs
Time Frame: Up to 3 years
Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
Up to 3 years
Number of participants with device related AEs, SAEs, and device deficiencies
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first event of ischemic stroke or SE
Time Frame: Up to 3 years
Time to first event of ischemic stroke or systemic embolism (SE). Undetermined strokes will be counted as ischemic strokes
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2027

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANT-010_OLE
  • 2023-503224-66-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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