AP02-003
Research type
Research Study
Full 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).
IRAS ID
1012881
Contact name
Ankita Taylor
Contact email
Sponsor organisation
Avalyn Pharma Inc.
Clinicaltrials.gov Identifier
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of fibrotic interstitial lung disease (ILD) characterized by cough and shortness of breath. The prognosis of patients with IPF is poor, with median life expectancy of 3 to 4 years after diagnosis. Two drugs are approved worldwide to treat IPF: oral nintedanib and oral pirfenidone (there is a third one called nerandomilast that is approved only in the United States). These drugs slow disease progression, but some patients find them difficult to take because of side effects like diarrhoea and other digestive problems which often require lowering the dose or stopping treatment. This study aims to learn more about a new inhaled solution of nintedanib, called AP02, how it affects lung function and lung scarring in adults with IPF, and how safe and tolerable it is. The results will help find the best dose and guide future development of AP02 as a treatment for IPF. This study will compare two doses of AP02 to a placebo (a look-alike substance that contains no active drug). Before starting, participants will have a screening period of up to 14 days to confirm eligibility. If eligible, patients will be randomly assigned to AP02 high dose, AP02 low dose, or placebo taken 2x a day using a nebulizer (described above). Participants are to be 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 using a nebulizer, which is a device that provides medicine to the lungs via inhalation. Participants will have a 3 in 8 chance of receiving placebo. The study will be double-blind meaning neither the participant nor the clinical team will know the treatment assigned. The study lasts 16 weeks and includes 6 in-clinic visits and 1 phone call. At site visits, breathing tests will be done to check lung function, ask patients to complete questionnaires, and review their overall health. Approximately 160 patients above 40 years old will participate in the study.
REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0923
Date of REC Opinion
21 Jan 2026
REC opinion
Further Information Favourable Opinion