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Clinical Trials in the EU / 2025-523431-19-00
Completed Phase II

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)

2025-523431-19-00 · tracked via the Priya Life Science EU tracker
Sponsor
Avalyn Pharma Inc.
Sponsor type
Pharmaceutical company
Therapeutic area
Respiratory Tract Diseases
Decision date
26/03/2026
Enrollment target
126
Sites
Germany, Italy, Spain, Ireland

Condition studied

Idiopathic Pulmonary Fibrosis (IPF)

Investigational medicinal product(s)

AP02 PlaceboAP02 LowAP02 High

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Change from baseline in the morning pre-dose forced vital capacity (FVC) (mL) at Week 12

Endpoint detail

Time to disease progression. Disease progression is defined as FVC percent predicted decline of ≥10% prior to Week 12, respiratory hospitalization, or death., Change from baseline in quantitative lung fibrosis metrics on HRCT at Week 12

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523431-19-00 on CTIS ↗ ← All trials in the EU