Printed from Voxsanity (voxsanity.com.au) — NCT06951217 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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:
People who previously took part in an Avalyn-sponsored inhaled antifibrotic clinical study for either idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), completed the final visit of the treatment period while on the full dose of the study drug (whether active or placebo), and have approval from the Study Physician. Note: People with IPF are excluded if they are based in the US or Canada.
Male participants and females who could potentially become pregnant must agree to use highly effective birth control from the time of the first dose (for males) or from signing the consent form (for females), throughout the study, and for 90 days after the last dose. Participants must also agree not to donate eggs or sperm during this same period.
Who may not be able to join:
People who did not previously participate in an Avalyn-sponsored inhaled antifibrotic lead-in study, or who were permanently withdrawn from that study for any reason — including those who stopped taking the study drug but continued attending visits.
People who had a worsening of asthma or chronic obstructive pulmonary disease (COPD) that required steroid tablets or injections within the 3 months before the first study visit.
People who had a sudden, serious worsening of IPF or PPF within the 3 months before the first study visit. (IPF participants are excluded from the US and Canada.)
People who are currently in another clinical study, or who received a different investigational drug (other than the Avalyn nebulised antifibrotic medication from their lead-in study) within the past 30 days or within 5 half-lives of that drug — whichever is the shorter timeframe. Participation in registries is generally permitted (confirm with trial site).
People who have a known allergy or hypersensitivity to pirfenidone or to any of the other ingredients used in the study medication.
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
Principal Investigator: Avalyn Pharma, Inc., Avalyn Pharma Inc.
Westmead Hospital, Westmead, New South Wales
000-000-000
The Queen Elizabeth Hospital, Woodville South, South Australia
Royal Prince Alfred Hospital, Camperdown,
(02) 95156120
The Prince Charles Hospital (TPCH), Chermside,
000-000-000
Lung & Sleep Victoria, Footscray,
Respiratory Clinical Trials PTY Ltd, Kent Town,
000-000-000
Nepean Lung & Sleep, Kingston,
Univ of Western Australia / Institute for Respiratory Health, Nedlands,
000-000-000
John Hunter Hospital, New Lambton Heights,
000-000-000
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: NCT06951217
Sponsor: Avalyn Pharma Inc.
Phase: Phase 2
Status: Recruiting
Condition: Interstitial Lung Disease
Trial contact: +44 7999 885973
More information: https://clinicaltrials.gov/study/NCT06951217
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:
People who previously took part in an Avalyn-sponsored inhaled antifibrotic clinical study for either idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), completed the final visit of the treatment period while on the full dose of the study drug (whether active or placebo), and have approval from the Study Physician. Note: People with IPF are excluded if they are based in the US or Canada.
Male participants and females who could potentially become pregnant must agree to use highly effective birth control from the time of the first dose (for males) or from signing the consent form (for females), throughout the study, and for 90 days after the last dose. Participants must also agree not to donate eggs or sperm during this same period.
Who may not be able to join:
People who did not previously participate in an Avalyn-sponsored inhaled antifibrotic lead-in study, or who were permanently withdrawn from that study for any reason — including those who stopped taking the study drug but continued attending visits.
People who had a worsening of asthma or chronic obstructive pulmonary disease (COPD) that required steroid tablets or injections within the 3 months before the first study visit.
People who had a sudden, serious worsening of IPF or PPF within the 3 months before the first study visit. (IPF participants are excluded from the US and Canada.)
People who are currently in another clinical study, or who received a different investigational drug (other than the Avalyn nebulised antifibrotic medication from their lead-in study) within the past 30 days or within 5 half-lives of that drug — whichever is the shorter timeframe. Participation in registries is generally permitted (confirm with trial site).
People who have a known allergy or hypersensitivity to pirfenidone or to any of the other ingredients used in the study medication.
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
Avalyn Pharma Inc.
Registry
ClinicalTrials.gov
Start date
17 April 2025
Est. completion
31 December 2031
Where this trial is recruiting
🇦🇺 Australia
🇨🇦 Canada
🇨🇿 Czechia
🇫🇷 France
🇩🇪 Germany
🇮🇹 Italy
🇳🇱 Netherlands
🇳🇿 New Zealand
🇵🇱 Poland
🇪🇸 Spain
🇬🇧 United Kingdom
🇺🇸 United States
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).
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.
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.