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Active, not recruitingNCT05683379Updated Jul 7, 2026

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

An observational study in Duchenne Muscular Dystrophy, sponsored by REGENXBIO Inc.. Active, not recruiting at 1 site in United States. Open to male participants aged 0 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by REGENXBIO Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
0 Years to 25 Years
Sex
Male
01

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).

Read the 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
02

Conditions studied

  • Duchenne Muscular Dystrophy

Keywords

  • DMD
  • Duchenne Muscular Dystrophy
  • Duchenne
03

In context

Muscular Dystrophy, Duchenne

473 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 107 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 130 observational studies indexed under Muscular Dystrophy, Duchenne.

Browse Muscular Dystrophy, Duchenne studies →

Lead sponsor

REGENXBIO Inc. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 25 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Primary care clinic, Musculoskeletal care, Neuromusculoskeletal care

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

Exclusion Criteria:

  • Prior participation in a gene therapy trial OR recipient of a gene therapy drug
  • Other inclusion/exclusion criteria apply
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testAAV8 DetectCDx

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

06

What researchers measure

Primary outcomes

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

    * 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

    Time frame: 90 days

07

Study locations

1 site
  • Rare Disease Research
    Atlanta, Georgia 30329, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05683379
Lead sponsor
REGENXBIO Inc.
Responsible party
Sponsor
First posted
Jan 13, 2023
Start date
Dec 20, 2022
Primary completion
Jun 30, 2026
Completion
Sep 2026 (estimated)
Last update
Jul 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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