AP01 for Idiopathic Pulmonary Fibrosis

(SAIL Trial)

Recruiting at 19 trial locations

Overseen By Dr. Felix Woodhead, MA, MB, BChir, FRCP, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Avalyn Pharma Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System for until such a time that the drug is approved, the participant withdraws from the study, or the study is terminated.

New patients will be trained to use the nebuliser at the first treatment visit. All patients will use the eFlow nebuliser to administer AP01. Hands on training for use and cleaning of the eFlow nebuliser will be performed by site personnel with patients using the study specific instructions for use and quick reference guide provided. The first treatment for new patients will be overseen by clinic personnel.

A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.

Are You a Good Fit for This Trial?

This trial is for people who have already completed an Avalyn-sponsored study for idiopathic or progressive pulmonary fibrosis. They must have taken their last dose of the previous study drug at full strength and agree to use effective contraception during the trial and for 90 days after.

Inclusion Criteria

I completed a previous Avalyn study for IPF or PPF on the full dose.

I agree to use effective birth control during and up to 90 days after the study.

What Are the Treatments Tested in This Trial?

Interventions

• AP01

Trial Overview Participants will inhale a solution called AP01, which contains pirfenidone, twice daily using an eFlow Nebulizer System. The treatment continues until drug approval, withdrawal from the study, or if the study ends. Training on nebulizer use is provided.

How Is the Trial Designed?

Group I: Open-label AP01 treatment arm Experimental Treatment 1 Intervention

All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability.

Who Is Running the Clinical Trial?

Avalyn Pharma Inc.

Lead Sponsor

Trials

1

Recruited

300+