NCT05683379

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: REGENXBIO Inc. · Industry
• Sex: Male
• Age: 0 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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 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

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AAV8 DetectCDx	An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.

Timeline

• Start date: 2022-12-20
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-01-13
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study