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

Launched by REGENXBIO INC. · Jan 12, 2023

Keywords

ClinConnect Summary

The AFFINITY BEYOND study is looking at boys with Duchenne Muscular Dystrophy (DMD) to learn more about how common certain antibodies are in their bodies. These antibodies are called anti-AAV8 antibodies, and they can affect how well gene therapies work. This is an observational study, meaning that researchers will simply observe and gather information without providing any treatment during the trial.

To participate, boys need to be aged between 0 and 12 years old and must have a confirmed diagnosis of DMD. They also need to have a parent or guardian provide consent for them to join the study. However, boys who have previously participated in a gene therapy trial or have received a gene therapy drug are not eligible to take part. If they join, participants can expect to undergo various assessments to help researchers understand the presence of these antibodies in boys with DMD. Overall, this study aims to gather important information that could help improve future treatments for DMD.

Gender

MALE

Eligibility criteria

• 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 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