Phase 2 Friedreich Ataxia Trial, Recruiting (NCT06874010)

Phase 2 Friedreich Ataxia Trial, Recruiting NCT06874010 Sponsor: Design Therapeutics, Inc. Condition: Friedreich Ataxia

Printed from Voxsanity (voxsanity.com.au) — NCT06874010 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Friedreich Ataxia

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 must be between 18 and 65 years old at the time of signing the consent form
You must have a diagnosis of Friedreich's Ataxia (FA) confirmed by genetic testing, specifically with a particular type of genetic change (called homozygous GAA repeat expansions) in the frataxin gene
Your condition must be at stage 5.5 or lower on a specific FA rating scale called the FSA (confirm with trial site)
Your body weight and body mass index (a measure of weight relative to height) must fall within a certain range: BMI between 16 and 32, and weight no more than 100 kg (about 220 lbs)
You must be willing to use an approved method of contraception (birth control) as required by the study
You must be able to understand and sign a consent form agreeing to take part

Who may not be able to join:

You have another medical condition that the study doctor believes could put you at risk or prevent you from completing the study
You have a significant non-medical condition or mental health condition that could affect your safety, your ability to participate, or the study results
You have taken part in another clinical trial or received an experimental treatment within the last 30 days (or longer, depending on the treatment) — though if you are currently taking Omaveloxolone at a stable dose for at least 3 months, you may still be eligible (confirm with trial site)
You are not willing to follow the contraception (birth control) requirements set out by the study

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: +613 8341 6228

Australian sites

Scientia Clinical Research Ltd, Sydney, New South Wales
+613 8341 6228

Doherty Clinical Trials, East Melbourne, Victoria
+613 8341 6228

Nucleus Network, Melbourne, Victoria
+613 8341 6228

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06874010

Sponsor: Design Therapeutics, Inc.

Phase: Phase 2

Status: Recruiting

Condition: Friedreich Ataxia

Trial contact: +613 8341 6228

More information: https://clinicaltrials.gov/study/NCT06874010

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You must be between 18 and 65 years old at the time of signing the consent form
You must have a diagnosis of Friedreich's Ataxia (FA) confirmed by genetic testing, specifically with a particular type of genetic change (called homozygous GAA repeat expansions) in the frataxin gene
Your condition must be at stage 5.5 or lower on a specific FA rating scale called the FSA (confirm with trial site)
Your body weight and body mass index (a measure of weight relative to height) must fall within a certain range: BMI between 16 and 32, and weight no more than 100 kg (about 220 lbs)
You must be willing to use an approved method of contraception (birth control) as required by the study
You must be able to understand and sign a consent form agreeing to take part

Who may not be able to join:

You have another medical condition that the study doctor believes could put you at risk or prevent you from completing the study
You have a significant non-medical condition or mental health condition that could affect your safety, your ability to participate, or the study results
You have taken part in another clinical trial or received an experimental treatment within the last 30 days (or longer, depending on the treatment) — though if you are currently taking Omaveloxolone at a stable dose for at least 3 months, you may still be eligible (confirm with trial site)
You are not willing to follow the contraception (birth control) requirements set out by the study

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 2

Sponsor

Design Therapeutics, Inc.

Registry

ClinicalTrials.gov

Start date

1 June 2025

Est. completion

1 December 2026

Where this trial is recruiting

🇦🇺 Australia

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Frequency of treatment-emergent adverse events (TEAE)

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