Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis
- Conditions
- 10038716Interstitial Lung Disease (ILD) which cause inflammation and scarring (firbrosis) of the lungs
- Registration Number
- NL-OMON52355
- Lead Sponsor
- Avalyn Pharma, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
A patient must meet the following inclusion criteria to be eligible for
enrollment in the clinical study:
1. Prior participant in an Avalyn AP01 study, excluding normal healthy
volunteers
OR
2. Patients with no other treatment options with ILDs including but not limited
to IPF, fibrosing phenotype ILD, pulmonary involvement of scleroderma,
rheumatoid lung and silicosis. Prior Sponsor (Avalyn Pharma, Inc.) approval of
non-Avalyn study rollover patients is required.
3. Diagnosed chronic progressive fibrotic lung disease, including IPF, without
treatment alternatives such as
a. Not eligible for oral pirfenidone and nintedanib due to national formulary
restrictions or lack of applicable regulatory approval
b. Intolerant to oral pirfenidone and nintedanib, if previously offered
c. Not eligible for an ongoing clinical study of AP01 other than this study
4. Age greater than 18 years at Screening
5. Able to understand and sign, prior to study entry, a written informed
consent form (ICF) consistent with International Council on Harmonisation
Guideline for Good Clinical Practice (ICH-GCP) and local laws
6. Able to understand the importance of adherence to study treatment and the
study protocol and willing to follow all study requirements, including the
concomitant medication restrictions, throughout the study
7. Females of childbearing potential must use an effective contraceptive method
during the clinical study and 30 days after the last dose of AP01
The presence of any of the following exclusion criteria excludes a patient from
study enrollment:
Disease-Related Exclusions
1. Significant clinical worsening of IPF/ILD between Screening and Day 1, in
the opinion of the Investigator
2. Not a suitable candidate for enrollment or unlikely to comply with the
requirements of this study, in the opinion of the Investigator
3. History of acute IPF exacerbation requiring hospitalization in the last 30
days
4. Clinical evidence of active infection, including but not limited to
bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
Medical Exclusions
5. Females with a positive pregnancy test at Screening or are currently
breastfeeding
6. Any history of malignancy likely to result in significant disability or
likely to require significant medical or surgical intervention within the next
6 months. This does not include minor surgical procedures for localized cancer
(e.g., basal cell carcinoma)
7. Any condition other than IPF that, in the opinion of the investigator, is
likely to result in the death of the patient within the next 6 months
8. History of severe hepatic impairment or end-stage liver disease or AST or
ALT greater than 5 times the upper limit of normal at Screening
9. History of end-stage renal disease requiring dialysis
10. Participation in a clinical study with administration of an investigational
drug product within the previous 30 days, or five half-lives of the previously
administered investigational product
11. Hypersensitivity to the active substance or to any of the excipients of
pirfenidone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety Outcome Measures<br /><br>• Treatment-emergent adverse events (AEs)<br /><br>• Treatment-emergent deaths<br /><br><br /><br>Efficacy Outcome Measures<br /><br>• No efficacy outcome measures</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>