A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.

⁃ Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).

• Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.

Locations
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
The Prince Charles Hospital (TPCH)
RECRUITING
Chermside
Respiratory Clinical Trials PTY Ltd
RECRUITING
Kent Town
Univ of Western Australia / Institute for Respiratory Health
RECRUITING
Nedlands
John Hunter Hospital
RECRUITING
New Lambton Heights
Westmead Hospital
RECRUITING
Westmead
Netherlands
St Antonius Hospital
RECRUITING
Nieuwegein
New Zealand
Greenlane Clinical Centre
RECRUITING
Auckland
Waikato Hospital
RECRUITING
Hamilton
United Kingdom
Leicester Biomedical Research Centre
RECRUITING
Leicester
Contact Information
Primary
Dr. Felix Woodhead, MA, MB, BChir, FRCP, PhD
fwoodhead@avalynpharma.com
+44 7999 885973
Time Frame
Start Date: 2025-04-17
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 340
Treatments
Experimental: Open-label AP01 treatment arm
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.
Sponsors
Leads: Avalyn Pharma Inc.

This content was sourced from clinicaltrials.gov

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