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RECRUITING

NCT07194382

PHASE2

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF

Sponsor: Avalyn Pharma Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability. Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months. Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation. Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-03-10

Completion Date

2027-06

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

AP02

Oral inhalation solution

DRUG

Placebo

Placebo oral inhalation solution

Inclusion Criteria: * Male or female patients aged ≥40 years at the time of signing the written informed consent form * Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de Tórax IPF guidelines within 5 years * Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF * In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation * Forced vital capacity (FVC) ≥45% predicted of normal * Lung diffusion test (DLCO) corrected for hemoglobin (Hgb) ≥30% and ≤80% predicted of normal. * Women and men of childbearing potential must use highly effective contraception measures until 90 days after the last dose of study drug. Exclusion Criteria: * Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study. * Forced expiratory volume (FEV) in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value * Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol) * History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit * History of cancer within the past 5 years (except for certain types explained in the protocol) * Participants who have smoked within the past 3 months prior to screening, who are not willing to stop smoking during the study, or who currently use illegal drugs or drugs of abuse * Female participants who are pregnant or nursing * Use of any investigational drugs including those for IPF within the past 30 days prior to screening Further inclusion/exclusion criteria apply

Locations (49)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Nepean Lung and Sleep

Kingswood, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Macquarie University Hospital

Sydney, New South Wales, Australia

Ludwig Engel Centre for Respiratory Research

Westmead, New South Wales, Australia

Launceston Respiratory and Sleep Centre

Launceston, Tasmania, Australia

Austin Health

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

University of Calgary - Foothills Medical Centre

Calgary, Alberta, Canada

Centre for Lung Health - Vancouver General Hospital

Vancouver, British Columbia, Canada

Newfoundland and Labrador Health Services

St. John's, Newfoundland and Labrador, Canada

Queen Elizabeth

Halifax, Nova Scotia, Canada

Dynamic Drug Advancement

Ajax, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

CIC Mauricie

Trois-Rivières, Quebec, Canada

Pneumologisches Studienzentrum München-West

Munich, Bavaria, Germany

Studienzentrum Dr. Keller

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Heidelberg - Thoraxklinik Heidelberg

Heidelberg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Christchurch Hospital

Christchurch, Cantebury, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Greenlane Clinical Centre

Auckland, New Zealand

Hospital Germans Trias i Pujol/Hospital Can Ruti

Badalona, Barcelona, Spain

Hospital General de Granollers, Barcelona

Granollers, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Catalonia / Barcelona, Spain

Consorci Corporació Sanitària Parc Taulí (Parc Taulí Hospital Universitari)

Sabadell, Catalonia / Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital HM Sanchinarro

Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Istanbul University Cerrahpasa Hospital

Istanbul, Turkey (Türkiye)

Gülhane Saglik Bilimleri Fakültesi

Keçiören, Turkey (Türkiye)

Royal Devon University Hospital

Exeter, Devon, United Kingdom

Hull University Hospitals NHS Trust

Cottingham, East Riding of Yorkshire, United Kingdom

Leicester Biomedical Research Centre

Leicester, Leicestershire, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital

Birmingham, United Kingdom

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Aintree University Hospital

Liverpool, United Kingdom

Royal Brompton Hospital, Guy's and St Thomas NHS Foundation Trust

London, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

Altnagelvin Hospital Campus

Londonderry, United Kingdom

Manchester University NHS Foundation Trust - NIHR Manchester Clinical Research Facility at Wythenshawe Hospital

Manchester, United Kingdom

Oxford University Hospitals NHS Foundation Trust - Churchill Hospital

Oxford, United Kingdom

NHS Tayside - Perth Royal Infirmiry (Scotland)

Perth, United Kingdom