Phase 3 Spinal Muscular Atrophy Trial, Recruiting (NCT07265232)

Phase 3 Spinal Muscular Atrophy Trial, Recruiting NCT07265232 Sponsor: Lantu Biopharma Condition: Spinal Muscular Atrophy

Printed from Voxsanity (voxsanity.com.au) — NCT07265232 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Spinal Muscular Atrophy

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 willing and able to sign a written consent form to take part in the study.
You must have a genetic test confirming you have Spinal Muscular Atrophy (SMA), shown by a specific change or missing section in the SMN1 gene.
Your doctor must believe that the treatment being studied (Vesemnogene) is likely to help you based on your type and current state of SMA.
You must not have any medical reasons that would make it unsafe for you to have a spinal tap (a procedure to inject medicine into the fluid around the spine).
You must have a low level of certain antibodies in your blood (below a specific threshold), measured by a lab test called an ELISA assay (confirm with trial site if unsure what this means for you).
Your liver must be working normally, based on standard blood test results.
You must either not be able to access currently available treatments for SMA, or have already tried them without success.

Who may not be able to join:

There are no listed exclusion criteria for this trial.

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 3: approximately ~65% 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.

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: NCT07265232

Sponsor: Lantu Biopharma

Phase: Phase 3

Status: Recruiting

Condition: Spinal Muscular Atrophy

More information: https://clinicaltrials.gov/study/NCT07265232

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 willing and able to sign a written consent form to take part in the study.
You must have a genetic test confirming you have Spinal Muscular Atrophy (SMA), shown by a specific change or missing section in the SMN1 gene.
Your doctor must believe that the treatment being studied (Vesemnogene) is likely to help you based on your type and current state of SMA.
You must not have any medical reasons that would make it unsafe for you to have a spinal tap (a procedure to inject medicine into the fluid around the spine).
You must have a low level of certain antibodies in your blood (below a specific threshold), measured by a lab test called an ELISA assay (confirm with trial site if unsure what this means for you).
Your liver must be working normally, based on standard blood test results.
You must either not be able to access currently available treatments for SMA, or have already tried them without success.

Who may not be able to join:

There are no listed exclusion criteria for this trial.

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 3

Sponsor

Lantu Biopharma

Registry

ClinicalTrials.gov

Start date

15 October 2025

Est. completion

15 October 2030

Where this trial is recruiting

🇮🇩 Indonesia

Primary endpoints

Numbers of participants with adverse events (AEs), serious adverse events (SAEs)

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