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

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)

Overview

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)

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.

Interventions

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

Primary outcome measures

• Time to first ISTH major Bleeding events [Time frame: Up to 3 years]
• Time to first BARC type 3c/5 bleeding [Time frame: Up to 3 years]
• Number of participants with ISTH major or CRNM bleeding [Time frame: Up to 3 years]
• Number of participants with bleeding [Time frame: Up to 3 years]
• Number of participants with TEAEs and TESAEs [Time frame: Up to 3 years]
• Number of participants with treatment discontinuations due to TEAEs [Time frame: Up to 3 years]
• Number of participants with device related AEs, SAEs, and device deficiencies [Time frame: Up to 3 years]

Secondary outcome measures (1)

• Time to first event of ischemic stroke or SE [Time frame: Up to 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07739888 · ANT-010_OLE · 2023-503224-66-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗