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An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

NCT06951217 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Progressive Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

COMBINATION_PRODUCT

AP01

AP01 will be administered open-label via the eFlow Nebulizer System

Sponsors & Collaborators

  • Avalyn Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Avalyn Pharma, Inc. · Avalyn Pharma Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2031-12-31
Completion
2031-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951217 on ClinicalTrials.gov