NCT06329401Phase 2Active not recruiting

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

Study sponsor: Avalyn Pharma Inc. · AVLN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-06Estimated

Enrollment · participants375Estimated

Source updated2026-07-02Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-18 · 1 field changed

Recruitment status

Recorded edit

− Previous value

Recruiting

+ Updated value

Active not recruiting

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Posted 2025-11-21 · 2 fields changed

Enrollment · participant count

Recorded edit

− Previous value

count: 300; type: ESTIMATED

+ Updated value

count: 375; type: ESTIMATED

Primary completion date

Recorded edit

− Previous value

2026-04

+ Updated value

2027-06

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Study details

Conditions studied

Pulmonary Fibrosis; Progressive Pulmonary Fibrosis; Pulmonary Fibrosis Secondary to Systemic Sclerosis; Pulmonary Fibrosis, Interstitial Lung Disease; Interstitial Lung Disease; Interstitial Lung Disease Due to Connective Tissue Disease (Disorder); Interstitial Lung Disease in Patients With Rheumatoid Arthritis; Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere; Hypersensitivity Pneumonitis; Interstitial Lung Disease With Systemic Sclerosis

Treatments or interventions studied

AP01DrugAlso known as Pirfenidone Solution

Primary outcomes · main study measures

measure: 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); description: Change from baseline in forced vital capacity (FVC) (mL); timeFrame: Week 52

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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