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NCT06329401 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
A Phase 2 study of Progressive Pulmonary Fibrosis, sponsored by Avalyn Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 375
- Enrollment target
- 20
- Study locations
NCT06329401: Recruiting Phase 2 study of Progressive Pulmonary Fibrosis, sponsored by Avalyn Pharma.
NCT06329401 is a Phase 2 study of Progressive Pulmonary Fibrosis that is actively recruiting participants, run by Avalyn Pharma. The registered enrollment target is 375 participants, below the 651-participant average among 7 other Progressive Pulmonary Fibrosis trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06329401, a Phase 2 study of Progressive Pulmonary Fibrosis, is actively recruiting participants, sponsored by Avalyn Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 375 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
Primary Outcome
Change from baseline in forced vital capacity (FVC) (mL)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG AP01
Study Locations (20)
California
- University of Southern California - Los Angeles
- Cedars-Sinai - Los Angeles
- UCLA - Los Angeles
- Newport Native MD, Inc. - Newport Beach
- Paradigm Clinical Research - Redding - Redding
- University of California - San Francisco - San Francisco
Florida
- Clinical Site Partners, LCC - Leesburg
- Renstar Medical Research - Ocala
- Clinical Site Partners - Winter Park
Illinois
- Northwestern University - Chicago
- Endeavor Health - Evanston
- Loyola University Medical Center - Maywood
Colorado
- University of Colorado, Anschutz Medical Campus - Aurora
- National Jewish Health - Denver
Connecticut
- UCONN Health - Farmington
- Yale University - New Haven
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic- Scottsdale - Scottsdale
Georgia
- Piedmont Healthcare, Inc. - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT06329401 shows while recruiting
NCT06329401 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 7 other Progressive Pulmonary Fibrosis trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Progressive Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06329401 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06329401 about?
NCT06329401 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis". A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
What is the current status of trial NCT06329401?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 375 participants. The study started on 2024-04-03. Estimated completion is 2027-06.
What conditions does trial NCT06329401 study?
This clinical trial studies the following conditions: Progressive Pulmonary Fibrosis.
What interventions are being tested in trial NCT06329401?
The interventions under investigation include: Placebo (OTHER), AP01 (DRUG).
Who is sponsoring clinical trial NCT06329401?
This trial is sponsored by Avalyn Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06329401 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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