Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM (FOREST-HCM)

Cytokinetics

Status and phase: Invitation-only; Phase 2

Conditions: Symptomatic Hypertrophic Cardiomyopathy (HCM)

Treatments: Drug: CK-3773274 (5 - 20 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04848506

CY 6022

2020-003571-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of a Cytokinetics trial investigating CK-3773274
• LVEF ≥55% at the Screening Visit

Exclusion criteria

• Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.

• Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.

• Since completion of a previous trial of CK-3773274 has:

  • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior trial of CK-3773274.

• Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274

• History of appropriate ICD shock within 30 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

CK-3773274 up to 20 mg

Experimental group

Description:

Patients in this arm take daily dose of CK-3773274. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.

Treatment:

Drug: CK-3773274 (5 - 20 mg)