An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

Phase 3

Recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: Aficamten

• Registration Number: NCT06116968
• Lead Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Brief Summary

This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-03
• Study Start: 2023-11-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2026-03-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days.
3. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
4. Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with aficamten.
5. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
6. Has received treatment with mavacamten.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aficamten	Aficamten	Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM.	through study completion, at least 1 year	* Patient incidence of reported adverse events (AEs); * Patient incidence of reported serious adverse events (SAEs); * Patient incidence of left ventricular ejection fraction (LVEF) \< 40 %

Trial Locations

Locations (12)

Fuwai Hospital, CAMS & PUMC; 🇨🇳 Beijing, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Jiangxi, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

Nanfang Hospital; 🇨🇳 Guangzhou, China

The First Hospital of Jilin University; 🇨🇳 Jilin, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

Beijing Chao-yang Hospital, Capital Medical University; 🇨🇳 Beijing, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, China