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

Plain-language summary

This study assesses anti-AAV8 antibody levels using the AAV8 DetectCDx test in males with DMD (Duchenne muscular dystrophy). It enrolls male participants from 0 to under 25 years of age with a diagnosis of DMD. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

REGENXBIO Inc.

Intervention

AAV8 DetectCDx

Start date

12/20/2022

Estimated completion

9/1/2026

Countries

United States

Related genes

Locations

• Atlanta, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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