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Anti-fibrotic agent

AP01 for Pulmonary Fibrosis

Phase 2

Recruiting

Research Sponsored by Avalyn Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Worsening respiratory symptoms with no alternative explanation

Radiological evidence of disease progression including 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

Must not have

Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF

Current treatment with oral pirfenidone within 3 months prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Summary

This trial will test whether a new drug, AP01, is safe and effective in treating a specific condition when added to standard treatment. Participants will receive either AP01 or a placebo for 52 weeks

Who is the study for?

This trial is for people with Progressive Pulmonary Fibrosis who have worsening respiratory symptoms, an FVC of at least 45%, and a DLCO of at least 30%. Those on nintedanib must meet specific criteria related to their treatment duration and stability. Participants need to be able to perform acceptable spirometry tests.

What is being tested?

The study is testing the safety and effectiveness of two doses of AP01 compared to a placebo in addition to standard care over one year. It's randomized, meaning participants are put into groups by chance, double-blind so neither they nor the researchers know who gets what, and placebo-controlled for comparison.

What are the potential side effects?

While not specified here, common side effects in trials like this may include gastrointestinal issues (like nausea or diarrhea), skin reactions (rash or itching), fatigue, coughing or shortness of breath that could worsen existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breathing problems are getting worse without any other known cause.

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My lung scans show worsening or new signs of lung damage.

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My lung function tests meet the required levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with IPF according to the ATS guidelines.

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I have been taking pirfenidone in the last 3 months.

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My kidney function is low, with a creatinine clearance under 30 mL/min.

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My liver tests are abnormal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

To evaluate the change from baseline in quantitative lung fibrosis score.

To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)

To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)

Other study objectives

To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo