Duchenne Muscular DystrophyNCT05683379
AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
An observational study of Duchenne Muscular Dystrophy, run by REGENXBIO Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 0 to 25 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- AAV8 DetectCDx
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Primary care clinic, Musculoskeletal care, Neuromusculoskeletal care
Who may be able to join
- 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
Who cannot join
- Prior participation in a gene therapy trial OR recipient of a gene therapy drug
- Other inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-AAV8 Antibody Assessment Study of Males With Duchenne Muscular Dystrophy Aged 0 to <25 Years
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
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- AAV8 DetectCDx
- Keywords
- DMD, Duchenne Muscular Dystrophy, Duchenne
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAV8 DetectCDxDiagnostic test
An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start20 Dec 2022
- Primary completion30 Jun 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- REGENXBIO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683379
- Sponsor's protocol ID
- RGX-202-0101
- Status last verified
- Jul 2026
- First submitted
- 4 Jan 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-AAV8 Antibody Assessment Study of Males With Duchenne Muscular Dystrophy Aged 0 to <25 Years
- ClinicalTrials.gov ID
- NCT05683379
- Acronym / sponsor ID
- RGX-202-0101
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- DMD, Duchenne Muscular Dystrophy, Duchenne
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- REGENXBIO Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary care clinic, Musculoskeletal care, Neuromusculoskeletal care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Prior participation in a gene therapy trial OR recipient of a gene therapy drug
- Other inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAV8 DetectCDxAn in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens. | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy, run by REGENXBIO Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anti-AAV8 antibodies in patients with DMD (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.