protocolSection identificationModule nctId: NCT06329401, orgStudyIdInfo id: AP01-007, briefTitle: A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Avalyn Pharma Inc., class: INDUSTRY, collaborators name: DevPro Biopharma, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks., conditionsModule conditions: Progressive Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: AP01, interventions name: Placebo, outcomesModule primaryOutcomes 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), secondaryOutcomes measure: To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL), secondaryOutcomes measure: To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52), secondaryOutcomes measure: To evaluate the change from baseline in quantitative lung fibrosis score., otherOutcomes measure: To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Newport Native MD, Inc., status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Paradigm Clinical Research - Redding, status: NOT_YET_RECRUITING, city: Redding, state: California, zip: 96001, country: United States, geoPoint lat: 40.58654, lon: -122.39168, locations facility: Clinical Site Partners, LCC, status: NOT_YET_RECRUITING, city: Leesburg, state: Florida, zip: 34748, country: United States, geoPoint lat: 28.81082, lon: -81.87786, locations facility: Renstar Medical Research, status: NOT_YET_RECRUITING, city: Ocala, state: Florida, zip: 34470, country: United States, geoPoint lat: 29.1872, lon: -82.14009, locations facility: Clinical Site Partners, status: NOT_YET_RECRUITING, city: Winter Park, state: Florida, zip: 32789, country: United States, geoPoint lat: 28.6, lon: -81.33924, locations facility: Accellacare, status: RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Southeastern Research Center, status: NOT_YET_RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Lowcountry Lung and Critical Care, status: RECRUITING, city: Charleston, state: South Carolina, zip: 29406, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False