A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)

Conditions

Idiopathic pulmonary fibrosis (IPF)

Brief summary

Change from baseline in absolute FVC (mL) at Week 52

Detailed description

Time to disease progression, defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52, Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52, Change from baseline in L-PF Dyspnoea Domain score at Week 52, Change from baseline in L-PF Cough Domain score at Week 52, Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD) questionnaire Total score at Week 52, Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%) at Week 52, Proportion of participants with treatment-emergent adverse events and serious adverse events, Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52

Related papers

No related papers found yet.

Interventions

DRUGBexotegrast

DRUGPlacebo matching PLN-74809

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in absolute FVC (mL) at Week 52	—

Secondary

Measure	Time frame
Time to disease progression, defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52, Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52, Change from baseline in L-PF Dyspnoea Domain score at Week 52, Change from baseline in L-PF Cough Domain score at Week 52, Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD) questionnaire Total score at Week 52, Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%) at Week 52, Proportion of participants with treatment-emergent adverse events and serious adverse events, Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through We	—

Measure

Time frame

Time to disease progression, defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through Week 52, Proportion of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52, Change from baseline in L-PF Dyspnoea Domain score at Week 52, Change from baseline in L-PF Cough Domain score at Week 52, Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD) questionnaire Total score at Week 52, Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%) at Week 52, Proportion of participants with treatment-emergent adverse events and serious adverse events, Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality through We

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Countries

Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed