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

Official title

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])

Overview

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.

Detailed description

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System.

The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug.

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

Interventions

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

Primary outcome measures

• To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01). [Time frame: Through end of study; average of 6 years]

Secondary outcome measures (3)

• To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on lung function the change from baseline in forced vital capacity (FVC) will be evaluated. [Time frame: Through end of study; average of 6 years]
• To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on stabilization of disease. [Time frame: Through end of study; average of 6 years]
• To evaluate the long-term impact of Avalyn nebulized antifibrotic medications on subject-reported quality of life (QoL). [Time frame: Through end of study; average of 6 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
• Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
• Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
• Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.
• History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 26 centers

• University of Alabama at Birmingham — Birmingham
• University of Southern California — Los Angeles
• University of Colorado, Anschutz Medical Campus — Aurora
• Renstar Medical Research — Ocala
• Piedmont Healthcare, Inc. — Atlanta
• The University of Kansas Medical Center — Kansas City
• University of Maryland — Baltimore
• Johns Hopkins Asthma and Allergy Center — Baltimore
• … and 18 more centers

Australia · 9 centers

• Westmead Hospital — Westmead
• The Queen Elizabeth Hospital — Woodville South
• Royal Prince Alfred Hospital — Camperdown
• The Prince Charles Hospital (TPCH) — Chermside
• Lung & Sleep Victoria — Footscray
• Respiratory Clinical Trials PTY Ltd — Kent Town
• Nepean Lung & Sleep — Kingston
• Univ of Western Australia / Institute for Respiratory Health — Nedlands
• … and 1 more center

Argentina · 5 centers

• Investigaciones En Patologias Respiratorias — San Miguel de Tucumán
• Fundación Respirar — Buenos Aires
• Instituto Ave Pulmo, Fundacion Enfisema — Buenos Aires
• CINME — Buenos Aires
• Hospital Italiano de Buenos Aires — Buenos Aires

New Zealand · 5 centers

• Greenlane Clinical Centre — Auckland
• Christchurch Hospital — Christchurch
• Bay of Plenty Clinical Trials Unit — Tauranga
• Dunedin Hospital — Dunedin
• Waikato Hospital — Hamilton

United Kingdom · 5 centers

• Hull University Teaching Hospital — Cottingham
• ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme — Birmingham
• Royal Papworth Hospital NHS Foundation Trust — Cambridge
• Leicester Biomedical Research Centre — Leicester
• St. George's University Hospitals NHS Foundation Trust — London

Canada · 4 centers

• Dynamic Drug Advancement — Ajax
• Research Institute McGill University Health Center — Montreal
• CIC Mauricie — Trois-Rivières
• Centre for Lung Health — Vancouver

Italy · 3 centers

• Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia — Pavia
• HUMANITAS Research Hospital — Milan
• Ospedale San Giuseppe/ MultiMedica SPA — Milan

Spain · 3 centers

• Hospital Universitario Virgen de las Nieves — Granada
• Hospital Gregorio Marañon — Madrid
• Hospital Universitario Virgen de la Victoria — Málaga

France · 2 centers

• University of Montpellier — Montrevel-en-Bresse
• Centre Hospitalier Universitaire d'Angers — Angers

Germany · 2 centers

• Medizinische Hochschule Hannover — Hanover
• Studienzentrum Dr. Claus Keller — Frankfurt

Poland · 2 centers

• Uniwersyteckie Centrum Kliniczne — Gdansk
• Department of Pneumology of the University Hospital No 1 — Lodz

Czechia · 1 center

• Fakultni Thomayerove nemocnice — Praha Klanovice

Netherlands · 1 center

• St Antonius Hospital — Nieuwegein

Identifiers

NCT: NCT06951217 · AP-LTE-008 · ACTRN12625000246482

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗