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A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522383-33-00
Enrollment
28
Registered
2026-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-04

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

Conditions

Familial pulmonary fibrosis, Interstitial lung diseases, Pulmonary fibrosis

Brief summary

Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial

Detailed description

Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104, Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104, Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial, Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial, Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks

Interventions

DRUGBI 1015550

Sponsors

Boehringer Ingelheim International GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial

Secondary

MeasureTime frame
Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104, Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104, Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial, Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial, Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 5, 2026