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INBUILD®

Study design

52-week, randomised, double-blind, placebo-controlled, phase 3 trial conducted in 15 countries

Study population

Patients with chronic progressive fibrotic ILDs, excluding patients with idiopathic pulmonary fibrosis (IPF)

Treatment arms

OFEV® 150 mg twice daily (n=332) or placebo (n=331)

Primary end-point

Annual rate of decline in the forced vital capacity (FVC), as assessed over a 52-week period

Key secondary end-points (measured at week 52)

Absolute change from baseline in the total score on the King’s Brief Interstitial Lung Disease (K-BILD) questionnaire

Time until the first acute exacerbation of interstitial lung disease or death

Time until death

Clinical ILD diagnoses for the INBUILD® study population

Inclusion criteria
Patients were required to meet at least one of the following criteria for progression of interstitial lung disease within the 24 months before screening, despite standard treatment with an agent other than nintedanib or pirfenidone: a relative decline in the FVC of at least 10% of the predicted value, a relative decline in the FVC of 5% to less than 10% of the predicted value and worsening of respiratory symptoms or an increased extent of fibrosis on high-resolution CT, or worsening of respiratory symptoms and an increased extent of fibrosis. At the time of enrollment, patients were required to have an FVC of at least 45% of the predicted value and a diffusing capacity of the lung for carbon monoxide (corrected for hemoglobin) of 30 to less than 80% of the predicted value. Enrolled patients had features of fibrotic lung disease affecting more than 10% of lung volume on high-resolution CT.

Exclusion criteria

Patients who were treated with azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, rituximab, cyclophosphamide, or oral glucocorticoids (at a dose of more than 20 mg per day for glucocorticoids) were excluded. These medicines were later permitted at the discretion of the investigator, following 6 months of study treatment.

Because patients with IPF had already been studied, specific efforts were made to enroll patients with a chronic progressive fibrotic phenotype other than IPF

Reference: Flaherty KR et al. N Engl J Med 2019;381:1718-1727 (and supplementary appendix).