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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523431-19-00

Enrollment

Registered

2026-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Brief summary

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

Detailed description

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

Interventions

DRUGAP02 High

DRUGAP02 Low

DRUGAP02 Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 27, 2026