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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04848506
Recruitment Status : Enrolling by invitation
First Posted : April 19, 2021
Last Update Posted : April 26, 2023
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04848506


Locations
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Sponsors and Collaborators
Cytokinetics
Investigators
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Study Director: Cytokinetics, MD Cytokinetics
More Information
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Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT04848506    
Other Study ID Numbers: CY 6022
2020-003571-17 ( EudraCT Number )
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
FOREST-HCM
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases