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OpenTrials
Active, not recruiting

NCT Number: NCT05683379

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

0 year–25 year

Sex eligibility

Male

Study type

Observational

Primary location

Rare Disease Research

Atlanta, Georgia, 30329, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AAV8 DetectCDx

Diagnostic Test

An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.

Primary outcomes

  1. Prevalence of anti-AAV8 antibodies in patients with DMD

    Time frame: 90 days

    • To evaluate the prevalence of AAV8 antibodies in patients with DMD
    • To identify participants who may be eligible for investigational gene therapy clinical trials in males with DMD

Sponsors and collaborators

Lead sponsor

REGENXBIO Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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