RecruitingPhase 2

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

United States375 participantsStarted 2024-04-03

Plain-language summary

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 participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments
✓. 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 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

Exclusion criteria

✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
✕. Bilirubin \>2.0 x ULN

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)

Timeframe: Week 52

Trial details

NCT IDNCT06329401

SponsorAvalyn Pharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Craig S. Conoscenti, MD

206-707-0304 cconoscenti@avalynpharma.com

View on ClinicalTrials.gov More Pulmonary Fibrosis trials