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

Anti-AAV8 Antibody Assessment Study of Males With Duchenne Muscular Dystrophy Aged 0 to <25 Years

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).

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

Inclusion Criteria:

• Males at least 0 to <25 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