Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation

NCT07739888 — Phase 3, Not yet recruiting, 2500 participants, Novartis Pharmaceuticals

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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)

Registry	NCT07739888, acronym LILAC-TIMI 76
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	2500 (Estimated)
Sponsor	Novartis Pharmaceuticals (Industry)
Conditions	Atrial Fibrillation (AF)
Interventions	Abelacimab (Biological)
Dates	start 2027-12-30 (estimated), primary completion 2030-12-30 (estimated), completion 2030-12-30 (estimated), first posted 2026-07-31, last updated 2026-07-31

-Summary

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)

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Abelacimab (MAA868)	Experimental	Biological: Abelacimab	abelacimab 150 mg subcutaneous (SC)

Abelacimab (Biological), also known as MAA868: Abelacimab provided as liquid in vial (150 mg/mL)

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 65 Years to any

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

+Funding

NIH grants: 2023