CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274) (REDWOOD-OLE)

• ClinicalTrials.gov Identifier: NCT04848506
• Recruitment Status: Enrolling by invitation
• First Posted: April 19, 2021
• Last Update Posted: March 2, 2022
• Sponsor: Cytokinetics
• Information provided by (Responsible Party): Cytokinetics

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Symptomatic Hypertrophic Cardiomyopathy (HCM)	Drug: CK-3773274 (5 - 20 mg)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study of CK-3773274 for Patients With Symptomatic Hypertrophic Cardiomyopathy (HCM)
• Actual Study Start Date: May 6, 2021
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: March 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: CK-3773274 up to 20 mg; 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.	Drug: CK-3773274 (5 - 20 mg); CK-3773274 tablets administered orally

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events observed during dosing of CK-3773274 in patients with HCM [ Time Frame: Baseline to End of study, up to 5 years ]
   Patient incidence of reported Adverse Events (AEs)

Secondary Outcome Measures :

1. Incidence of serious adverse events observed during dosing of CK-3773274 in patients with HCM [ Time Frame: Baseline to End of study, up to 5 years ]
   Patient incidence of reported Serious Adverse Events (SAEs)
2. Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with HCM [ Time Frame: Baseline to End of study, up to 5 years ]
   Patient incidence of reported LVEF <50%
3. Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G) in patients with oHCM [ Time Frame: Baseline through the end of participation at 12-week intervals ]
   Peak LVOT-G at rest

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening

• 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.
• Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries)
• Has moderate or severe aortic valve stenosis
• Had a confirmed LVEF <40% with an associated dose interruption during CY 6021
• History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
• History of appropriate ICD shock within 30 days prior to screening
• Has received treatment with mavacamten

Contacts and Locations

Locations

United States, California

Cedars-Sinai Medical Center (Smidt Heart Institute)

Los Angeles, California, United States, 90048

UCSF Medical Center

San Francisco, California, United States, 94143

United States, Illinois

Northwestern University

Evanston, Illinois, United States, 60208

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Michigan

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, North Carolina

Sanger Heart & Vascular Institute - HCM Clinic

Charlotte, North Carolina, United States, 28204

Duke Cardiology at Southpoint

Durham, North Carolina, United States, 27710

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Pennsylvania

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

Philadelphia, Pennsylvania, United States, 19104

Italy

Unit Cardiomiopatie, Dipartimento Cardio ToracoVascolare

Firenze, Italy, 50134

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain, 28220

Sponsors and Collaborators

Cytokinetics

Investigators

• Study Director: Cytokinetics, MD; Cytokinetics

More Information

• Responsible Party: Cytokinetics
• ClinicalTrials.gov Identifier: NCT04848506
• Other Study ID Numbers: CY 6022; 2020-003571-17 ( EudraCT Number )
• First Posted: April 19, 2021
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cytokinetics:

Obstructive Hypertrophic Cardiomyopathy; oHCM; CK-3773274; CK-274; Non obstructive hypertrophic cardiomyopathy; nHCM; HCM; Hypertrophic cardiomyopathy; Aficamten; REDWOOD-OLE; CY 6022

Additional relevant MeSH terms:

Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases