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Looking for participantsPhase2

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Sponsor: Avalyn Pharma Inc.

NCT ID: NCT06951217

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AP01 (combination product)
How long the study runs
Study runs about 80 months (dates as stated)
About the drug or intervention
AP01 — combination product: AP01 will be administered open-label via the eFlow Nebulizer System
Patient visit burden
"Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day." (as stated by sponsor)

In plain English

This extension study, run by Avalyn Pharma Inc., is for people who took part in an earlier Avalyn study of an inhaled antifibrotic medicine for progressive pulmonary fibrosis (PPF) or idiopathic pulmonary fibrosis (IPF). It lets them keep receiving the study medicine after finishing the treatment period of their previous study. Note that people with IPF are excluded in the United States and Canada.

Who can take part

  • You finished the final visit of the treatment period of a previous Avalyn study of an inhaled antifibrotic medicine, at the full dose (either the real medicine or a placebo), and the study doctor agrees you can take part.
  • Men, and women who could become pregnant, must use highly effective contraception from the first dose (for men) or from signing the consent form (for women), during the study, and for 90 days after the last dose. You must also agree not to donate eggs or sperm during this time.

Who may not be able to

  • You did not take part in a previous Avalyn inhaled antifibrotic study, or you were permanently stopped from that study for any reason. If you stopped the study medicine but kept going to visits, you cannot take part.
  • You had an asthma or chronic obstructive pulmonary disease (COPD) flare-up needing steroid tablets or injections in the 3 months before the first study day.
  • You had a sudden worsening of IPF or PPF in the 3 months before the first study day.
  • You took part in another clinical study, or received a different investigational medicine, in the past 30 days or within 5 half-lives of that medicine (whichever is shorter). Taking part in registries is allowed.
  • You have had a bad allergic reaction to pirfenidone or to any of the other ingredients used in this study.

What taking part involves

  • • Continuing an inhaled (nebulised) antifibrotic study medicine from your previous Avalyn study.
  • • Using highly effective contraception during the study and for 90 days after the last dose, if this applies to you.

Time commitment: Number of visits and study length are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
340
Started
2025-04-17
Last checked
2026-02

Plain English Summary

What is this study?

  • • Testing a new treatment for progressive pulmonary fibrosis
  • • Phase2 - 340 participants
  • • This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with progressive pulmonary fibrosis

Where?

  • • Cottingham - Hull University Teaching Hospital
  • • Oxford - Oxford University Hospitals NHS Foundation Trust
  • • Birmingham - ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
  • • Cambridge - Royal Papworth Hospital NHS Foundation Trust
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

More detail

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System. The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug. A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.

Progressive Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of...

Who cannot take part

  • ✗Subjects who experienced an exacerbation of asthma or of chronic obstructive lung disease (COPD) requiring oral...
  • ✗Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF...
  • ✗History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.
See the full criteria
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.

Where Is This Study? (6 UK sites)

Hull University Teaching Hospital

Cottingham HU16 5JQ, United Kingdom

Recruiting
Site contact (verified)
Simon HartPrincipal Investigator

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Rachel HoylesPrincipal Investigator

ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)
Anjali CrawshawPrincipal Investigator

Royal Papworth Hospital NHS Foundation Trust

Cambridge CB2 0AY, United Kingdom

Recruiting
Site contact (verified)
Helen ParfreyPrincipal Investigator

Leicester Biomedical Research Centre

Leicester, United Kingdom

Recruiting
Site contact (verified)
Charlotte SwalesPrincipal Investigator

St. George's University Hospitals NHS Foundation Trust

London SW17 0RE, United Kingdom

Recruiting
Site contact (verified)
Aul RaminderPrincipal Investigator

How to Get in Touch

Dr. Felix Woodhead, MB BChir,PhD

Sponsor contact

CONTACT

+44 7999 885973 fwoodhead@avalynpharma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02