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A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523369-32-00
Enrollment
6
Registered
2026-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-07

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

Conditions

Fibrosing interstitial lung disease

Brief summary

"AUCT,SS based on sampling at steady state using rich sampling (at Week 2 in Part A and at Week 28 in Part B) in participants from 6 years to less than 18 years and sparse sampling (at Week 2 of Part A) in participants younger than 6 years ", Occurrence of a treatment-emergent adverse event (Yes/No) up to Week 26

Detailed description

Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest at Week 26 and Week 52, Absolute change from baseline in height [cm] at Week 26 and Week 52, Absolute change from baseline in PedsQL™ at Week 26 and Week 52, Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial, Time to first respiratory-related hospitalisation [days] over the whole trial, Time to first acute ILD exacerbation or death [days] over the whole trial, Time to death [days] over the whole trial, Acceptability based on number/size of tablets at Week 2 and Week 26, Acceptability based on the use of the dispenser at Week 2 and Week 26, Absolute change from baseline in FVC [% predicted] at Week 26 and Week 52 (applicable to participants ≥6 years), Absolute change from baseline in 6-min walk distance [m] at Week 26 and Week 52 (applicable to participants ≥6 years)

Interventions

DRUGBI 1015550
DRUGPlacebo

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
"AUCT,SS based on sampling at steady state using rich sampling (at Week 2 in Part A and at Week 28 in Part B) in participants from 6 years to less than 18 years and sparse sampling (at Week 2 of Part A) in participants younger than 6 years ", Occurrence of a treatment-emergent adverse event (Yes/No) up to Week 26

Secondary

MeasureTime frame
Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest at Week 26 and Week 52, Absolute change from baseline in height [cm] at Week 26 and Week 52, Absolute change from baseline in PedsQL™ at Week 26 and Week 52, Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial, Time to first respiratory-related hospitalisation [days] over the whole trial, Time to first acute ILD exacerbation or death [days] over the whole trial, Time to death [days] over the whole trial, Acceptability based on number/size of tablets at Week 2 and Week 26, Acceptability based on the use of the dispenser at Week 2 and Week 26, Absolute change from baseline in FVC [% predicted] at Week 26 and Week 52 (applicable to participants ≥6 years), Absolute change from baseline in 6-min walk distance [m] at Week 26 and Week 52 (applicable to participants ≥6 years)

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 8, 2026