NCT06329401
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentAvalyn Pharma Inc.
~375 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:AP01Placebo
At a glance
Recruiting sites
0 of 154 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
Measured over Week 52
Conditions
Where it's being run
154 sites across 88 statesNew York7
California6
Texas6
Buenos Aires6
New South Wales5
United Kingdom5
North Carolina4
Oregon4
Study leadership
- Avalyn Pharma, Inc. · STUDY_DIRECTOR · Avalyn Pharma Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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:
Exclusion
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:
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.
What this trial measures
- To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)Week 52
Change from baseline in forced vital capacity (FVC) (mL)