Phase 2 study for people with Interstitial Lung Disease

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 12 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Avalyn Pharma Inc.
Registry number NCT06951217
Started 17 April 2025 Today 16 October 2026 Estimated completion 31 December 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal Prince Alfred Hospital Camperdown NSW Recruiting
Macquarie University Clinical Trials Unit Macquarie Park NSW Recruiting
Westmead Hospital Westmead NSW Recruiting
Wallace Street Specialist Centre/Lung Research QLD Pty Ltd Brisbane QLD Recruiting
The Queen Elizabeth Hospital Woodville South SA Active not recruiting
Alfred Health Melbourne VIC Recruiting
The Prince Charles Hospital (TPCH) Chermside Australia Recruiting
Lung & Sleep Victoria Footscray Australia Recruiting
Respiratory Clinical Trials PTY Ltd Kent Town Australia Recruiting
Nepean Lung & Sleep Kingston Australia Recruiting
Univ of Western Australia / Institute for Respiratory Health Nedlands Australia Recruiting
John Hunter Hospital New Lambton Heights Australia Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 340

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:

* Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.

Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).

* Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.

Exclusion Criteria:

* Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.

* Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).

* Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).

* Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.

* History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.

Dates on the record

Started 17 April 2025
Estimated completion 31 December 2031
Registry last updated 2 October 2026
Checked by Voxsanity 12 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 2 October 2026.
  • This page last checked by Voxsanity: 12 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.