Phase 2 study for people with Muscular Dystrophy

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Soufflé Therapeutics, Inc.
Registry number NCT07798609
Started 1 September 2026 Today 16 October 2026 Estimated completion 1 March 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Concord Repatriation General Hospital Concord NSW Not yet recruiting
Liverpool Hospital Liverpool NSW Not yet recruiting
Wesley Research Institute Brisbane QLD Not yet recruiting
Mater Hospital Brisbane South Brisbane QLD Recruiting
The Alfred Hospital Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years to 65 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 90

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Genetically confirmed diagnosis of FSHD 1 or 2

* FSHD Clinical Severity Score ≥1.5 to ≤4 at screening (5-point Ricci scale)

* Ambulatory and able to walk 10 meters between ≥5 and ≤14 seconds (only assistive devices allowed are single cane or splints for ankle-foot orthoses)

* Must have eligible lower extremity muscle for biopsy as determined from MRI by a central reader

Exclusion Criteria:

* History of any illness or any clinical condition that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering investigational product to the participant.

* History of biopsy of the same muscle within 30 days of the Screening biopsy or planning to undergo any non-study muscle biopsies over the duration of the study

* Treatment with an oligonucleotide, gene therapy, or other experimental therapies for FSHD.

Dates on the record

Started 1 September 2026
Estimated completion 1 March 2028
Registry last updated 9 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 9 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.