A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Avalyn Pharma Inc.
Study ID
NCT06329401
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hypersensitivity Pneumonitis
  • Interstitial Lung Disease
  • Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
  • Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere
  • Interstitial Lung Disease With Systemic Sclerosis
  • Interstitial Lung Disease in Patients With Rheumatoid Arthritis
  • Progressive Pulmonary Fibrosis
  • Pulmonary Fibrosis
  • Pulmonary Fibrosis Secondary to Systemic Sclerosis
  • Pulmonary Fibrosis, Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AP01 — DRUG
    Oral inhalation solution
  • Placebo — OTHER
    Placebo oral inhalation solution

Study Details

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.

Key Dates

Start date
Apr 3, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AP01 High Dose BID
    Pirfenidone Solution for Inhalation
  • Experimental: AP01 Low Dose BID
    Pirfenidone Solution for Inhalation
  • Placebo Comparator: Placebo BID
    Placebo solution for inhalation

Primary Outcome Measure

To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID) [ Time Frame: Week 52 ]

Central Contacts

Locations (59)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205-
Mayo Clinic- ScottsdaleScottsdaleArizona85259
Vivek Nagaraja
000-000-000
Vivek Nagaraja
Cedars-SinaiLos AngelesCalifornia90048-
UCLALos AngelesCalifornia90095-
University of Southern CaliforniaLos AngelesCalifornia90033-
Newport Native MD, Inc.Newport BeachCalifornia92663-
Paradigm Clinical Research - ReddingReddingCalifornia96001-
University of California - San FranciscoSan FranciscoCalifornia94143
Golden Jeffrey
000-000-000
Golden Jeffrey
University of Colorado, Anschutz Medical CampusAuroraColorado80045-
National Jewish HealthDenverColorado80206-
UCONN HealthFarmingtonConnecticut06030-
Yale UniversityNew HavenConnecticut06519-
Clinical Site Partners, LCCLeesburgFlorida34748-
Renstar Medical ResearchOcalaFlorida34470-
Clinical Site PartnersWinter ParkFlorida32789-
Piedmont Healthcare, Inc.AtlantaGeorgia30309-
Northwestern UniversityChicagoIllinois60611-
Endeavor HealthEvanstonIllinois60201-
Loyola University Medical CenterMaywoodIllinois60153-
The University of Kansas Medical CenterKansas CityKansas66160-
Johns Hopkins UniversityBaltimoreMaryland21224-
University of MarylandBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic RochesterRochesterMinnesota55905-
Hannibal Regional Healthcare SystemHannibalMissouri63401-
Northwell Health - Mount KiscoMount KiscoNew York10549-
Columbia UniversityNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10017-
Weill CornellNew YorkNew York10021-
Montefiore Medical CenterThe BronxNew York10467-
Duke UniversityDurhamNorth Carolina27710-
Piedmont HealthCare, PAStatesvilleNorth Carolina28625-
AccellacareWilmingtonNorth Carolina28401-
Southeastern Research CenterWinston-SalemNorth Carolina27103-
University of CincinnatiCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
Summit HealthBendOregon97701-
The Oregon Clinic Pulmonary EastPortlandOregon97220-
The Oregon Clinic Pulmonary WestPortlandOregon97225-
The Pennsylvania State UniversityHersheyPennsylvania17033-
Temple UniversityPhiladelphiaPennsylvania19140-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Lowcountry Lung and Critical CareCharlestonSouth Carolina29406-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Clinical Trials Center of Middle TennesseeFranklinTennessee37067-
Vanderbilt Lung InstituteNashvilleTennessee37204-
Baylor Scott & White Research Institute, Baylor University Medical CenterDallasTexas75246-
UT Southwestern Medical CenterDallasTexas75390
Corey Kershaw
000-000-000
Corey Kershaw
El Paso Pulmonary AssociationEl PasoTexas79902-
Baylor College of MedicineHoustonTexas77030-
The University of Texas Health Science CenterHoustonTexas77030-
Metroplex Pulmonary and Sleep Center, PAMcKinneyTexas75069-
Intermountain Medical CenterMurrayUtah84157-
University of Utah HealthSalt Lake CityUtah84108-
Inova HealthcareFalls ChurchVirginia22042-
University of WashingtonSeattleWashington98195-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic- Scottsdale· Scottsdale, AZCedars-Sinai· Los Angeles, CAUCLA· Los Angeles, CAUniversity of Southern California· Los Angeles, CANewport Native MD, Inc.· Newport Beach, CA

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