Phase 2 Muscular Dystrophy Trial, Recruiting NCT05230459 Sponsor: AskBio Inc Condition: Muscular Dystrophy
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Phase 2 Muscular Dystrophy Trial, Recruiting

NCT05230459
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man or woman between 18 and 65 years old with a diagnosis of a muscle disease called LGMD2I/R9, confirmed by a genetic test showing a change in the FKRP gene.
  • You are able to walk or run 10 meters in less than 30 seconds.
  • You are able to understand and follow all the steps involved in the study.
  • If you are a woman who could become pregnant, or a male participant whose partner could become pregnant, you must be willing to use a barrier form of contraception (such as condoms) for the first 6 months after receiving the study treatment.

Who may not be able to join:

  • You have significant heart problems, such as a weakened heart (pumping less than 40% efficiency), certain heart rhythm or electrical issues, moderate-to-severe heart failure, or scarring of the heart muscle shown on a scan.
  • You cannot have an MRI scan, or you have had allergic reactions to contrast dyes, shellfish, or iodine.
  • You have implanted metal devices such as spinal rods, a pacemaker, or other implants that could affect heart scan images.
  • You have an active or ongoing liver disease (such as hepatitis) or abnormal liver blood test results.
  • Your kidneys are not working well enough, based on a specific blood test measuring kidney function.
  • You have or have had a serious or life-threatening illness, including most cancers, within the past 5 years (skin cancers of certain types may be excepted — confirm with trial site).
  • In the doctor's opinion, you have an existing health condition that makes the risks of joining greater than the potential benefits.
  • You need a breathing machine or ventilator during the day.
  • Your steroid medication dose has been changed within the last 3 months.
  • You have taken part in another drug trial in the last 3 months, or you have ever received gene therapy before.
  • You are currently taking part in another treatment-based clinical trial.
  • A blood test shows a high level of antibodies against a specific virus used in the study treatment (AAV9), above a level of 1:5 (confirm with trial site).
  • You are pregnant, planning to become pregnant in the next 12 months, or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 919-561-6210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
AskBio Inc
Registry
ClinicalTrials.gov
Start date
15 May 2023
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov