An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Purpose
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.
Conditions
- Progressive Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis (IPF)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Aurora 5412347, Colorado 5417618 80045
Joyce Lee
000-000-000
Ocala 4166673, Florida 4155751 34470
Raj Karunakara
Rochester 5043473, Minnesota 5037779 55901
Andrew Limper
000-000-000
New York 5128581, New York 5128638 10032
Claire McGroder
000-000-000
Winston-Salem 4499612, North Carolina 4482348 27103
Jason Thomason
336-765-0383
Cincinnati 4508722, Ohio 5165418 45267
Nishant Gupta
000-000-000
Kansas 5159405, Ohio 5165418 66160
Mark Hamblin
000-000-000
Philadelphia 4560349, Pennsylvania 6254927 19107
Ross Summer
000-000-000
Charleston 4574324, South Carolina 4597040 29425
Timothy Whelan
000-000-000
More Details
- NCT ID
- NCT06951217
- Status
- Recruiting
- Sponsor
- Avalyn Pharma Inc.
Study Contact
Dr. Felix Woodhead, MA, MB, BChir, FRCP, PhD+44 7999 885973
fwoodhead@avalynpharma.com