Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Sanofi
Registry number NCT06082037
Started 10 October 2023 Today 16 October 2026 Estimated completion 29 January 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Investigational Site Number : 0360003 Darlinghurst NSW Recruiting
Investigational Site Number : 0360001 Brisbane QLD Recruiting
Investigational Site Number : 0360002 Murdoch WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 180

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:

* Participant ≥1 year post bilateral lung transplantation at the time of screening

* Participants presenting with CLAD Stage 1 or 2: FEV1 from \>50% to 80% of post-transplant baseline at screening and at randomization

* Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization

Exclusion Criteria:

* FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)

* Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (\>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Dates on the record

Started 10 October 2023
Estimated completion 29 January 2029
Registry last updated 23 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 23 September 2026.
  • This page last checked by Voxsanity: 11 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.