A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
← catalyst calendarNCT06329401 · readout ≤ 315 d
Sponsored by Avalyn Pharma Inc. (industry) · AVLN — their whole pipeline →. With DevPro Biopharma.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
375estimated
Sites
154
Countries
Argentina, Australia, Belgium +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-03 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- 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
Interventions
- Drug: AP01 — also filed as Pirfenidone Solution
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFTo 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 Week 52
Publications
- PMID 36948586 — reports results
- PMID 41448793 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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