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ACTIVE NOT RECRUITINGPhase2

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Sponsor: Avalyn Pharma Inc.

NCT ID: NCT06329401

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 (drug), Placebo (other)
How long the study runs
Study runs about 38 months (dates as stated)
About the drug or intervention
AP01 — drug: Oral inhalation solution · Placebo — other: Placebo oral inhalation solution
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
375
Started
2024-04-03
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary fibrosis
  • • Phase2 - 375 participants
  • • A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks

Who can take part?

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

Where?

  • • Cottingham - Hull University Teaching Hospital NHS Trust
  • • Birmingham - Birmingham Heartlands Hospital
  • • Glenfield - Leicester Biomedical Research Centre - Respiratory Theme
  • • London - St George's University Hospitals NHS Foundation Trust
  • • +11 more UK sites

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

About This Trial

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

More detail

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.

Pulmonary FibrosisProgressive Pulmonary FibrosisPulmonary Fibrosis Secondary to Systemic SclerosisPulmonary Fibrosis, Interstitial Lung DiseaseInterstitial Lung DiseaseInterstitial Lung Disease Due to Connective Tissue Disease (Disorder)Interstitial Lung Disease in Patients With Rheumatoid ArthritisInterstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified ElsewhereHypersensitivity PneumonitisInterstitial Lung Disease With Systemic Sclerosis

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
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Still need:

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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

Treatment history

Treatments you must have had:

  • ✓ been on nintedanib for at least 6 months

What the study is looking for

  • ✓Participant meets criteria for PPF, as follows:
  • ✓In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic lung...
  • ✓Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with...
  • ✓Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry...
  • ✓Relative decline in FVC ≥5% to \<10% predicted within the previous 24 months based on documented historical...

Who cannot take part

  • ✗Current treatment with oral pirfenidone or treatment with oral pirfenidone within 3 months prior to Screening.
  • ✗Elevated liver enzymes and liver injury at Screening defined as:
  • ✗Alanine aminotransferase (liver enzymes) or aspartate aminotransferase (liver enzymes) ˃ 3 times the upper limit of normal (ULN)
  • ✗liver blood test \>2.0 x ULN
  • ✗kidney disease with a creatinine clearance \< 30 mL/min, calculated according to the Chronic Kidney Disease...
See the full criteria
Inclusion Criteria: * Participant meets criteria for PPF, as follows: * In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as: Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator): 1. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments 2. Relative decline in FVC ≥5% to \<10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria: * Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR * Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example: * Increased extent or severity of traction bronchiectasis and bronchiolectasis * New ground-glass opacity with traction bronchiectasis * New fine reticulation * Increased extent or increased coarseness of reticular abnormality * New or increased honeycombing * Increased lobar volume loss 3. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist * Meeting all of the following criteria during the Screening Period: a. FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits). • For subjects already on nintedanib (up to 30% of subjects): Must have been on nintedanib for at least 6 months prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued nintedanib prior to Screening: Must have been off of nintedanib for a minimum of 12 weeks. Exclusion Criteria: * Current treatment with oral pirfenidone or treatment with oral pirfenidone within 3 months prior to Screening. * Elevated liver enzymes and liver injury at Screening defined as: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN) 2. Bilirubin \>2.0 x ULN * Renal disease with a creatinine clearance \< 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once. * Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary. * Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process. * Significant clinical worsening of PPF between Screening * Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.

Where Is This Study? (15 UK sites)

Hull University Teaching Hospital NHS Trust

Cottingham HU16 5JQ, United Kingdom

Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Birmingham Heartlands Hospital

Birmingham B95SS, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Leicester Biomedical Research Centre - Respiratory Theme

Glenfield LE3 9QP, United Kingdom

Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

St George's University Hospitals NHS Foundation Trust

London sw17 0QT, United Kingdom

Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

Birmingham B15 2GW, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

C-TRIC Altnagelvin Hospital

Londonderry BT46, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Royal Devon

Exeter EX2 5DW, United Kingdom

Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development

Wolverhampton WV10 0QP, United Kingdom

Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

St James University Hospital - LTHT

Leeds LS9 7TF, United Kingdom

Royal Papworth Hospital

Cambridge CB2 0BB, United Kingdom

Hospital R&D contact (matched)

Vikki Hughes

papworth.randdenquiries@nhs.net01223 638000

Royal Brompton Hospital

London SW3 6HP, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Manchester University NHS Foundation Trust

Manchester M23 9LT, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Nottingham University NHS Trust

Nottingham NG5 1PB, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385
Data sourced from ClinicalTrials.gov · Last verified: 2026-06