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NCT07926321

A Study to Test Whether BI 3810477 Helps People With Idiopathic Pulmonary Fibrosis When Taken With or Without Standard Treatment

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below.

  1. Minor Trial sites expanded: 37 → 42 locations
  2. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 12
Timeframe: At baseline and at Week 12.

Secondary (4)

Absolute change from baseline in quantitative lung fibrosis (QLF) Draft[%] on high-resolution computed tomography (HRCT) at Week 12
Absolute change from baseline in log10-transformed Surfactant protein-D (SP-D) plasma concentration [ng/mL] at Week 12
Absolute change from baseline in FVC % predicted at Week 12
Absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO) % predicted at Week 12

Arms and interventions

PlaceboPlacebo comparator
BI 3810477Experimental

Other: Placebo

Biologicals: BI 3810477

Sites

42 sites in 9 countries

United States 13, Japan 7, Germany 5, Spain 4, Finland 3, Mexico 3, South Korea 3, United Kingdom 3, Belgium 1