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

Last updated: April 2, 2025
Sponsor: REGENXBIO Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Muscular Dystrophy

Treatment

AAV8 DetectCDx

Clinical Study ID

NCT05683379
RGX-202-0101
  • Ages < 11
  • Male

Study 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).

Eligibility Criteria

Inclusion

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 perlocal regulations or requirements

Exclusion

Exclusion Criteria:

  • Prior participation in a gene therapy trial OR recipient of a gene therapy drug

  • Other inclusion/exclusion criteria apply

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: AAV8 DetectCDx
Phase:
Study Start date:
December 20, 2022
Estimated Completion Date:
September 30, 2026

Study 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

Connect with a study center

  • Rare Disease Research

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

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