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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

2026-08-10

Healthy Volunteers

No

Interventions

DRUG

AP02

Oral inhalation solution

DRUG

Placebo

Placebo oral inhalation solution

Locations (24)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Nepean Lung and Sleep

Kingswood, New South Wales, Australia

Ludwig Engel Centre for Respiratory Research

Westmead, New South Wales, Australia

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

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

CIC Mauricie

Trois-Rivières, Quebec, Canada

Pneumologisches Studienzentrum München-West

Munich, Bavaria, Germany

Studienzentrum Dr. Keller

Frankfurt am Main, Hesse, 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 Clínic de Barcelona

Barcelona, Spain

Hospital HM Sanchinarro

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

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