AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD

Regenxbio

Status: Enrolling

Conditions: Duchenne Muscular Dystrophy

Treatments: Diagnostic Test: AAV8 DetectCDx

Study type: Observational

Funder types: Industry

Identifiers

NCT05683379

RGX-202-0101

Details and patient eligibility

About

This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD).

Full description

This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD). Information collected in this study may be used to identify potential participants for DMD investigational gene therapy clinical trials.

This study consists of:

• A phone/video interview to provide e-consent and medical history
• A single home health visit to collect blood sample for antibody testing
• A phone/video call for communication of AAV8 antibody test results

Enrollment: 200 estimated patients

Sex: Male

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males at least 0 to <12 years of age
• Diagnosis of DMD
• Provision of signed and dated informed consent form (ICF) and assent as required per local regulations or requirements

Exclusion criteria

• Prior participation in a gene therapy trial OR recipient of a gene therapy drug
• Other inclusion/exclusion criteria apply