A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512849-17-00

Acronym

1305-0046

Enrollment

158

Registered

2025-03-25

Start date

2025-11-14

Completion date

Unknown

Last updated

2026-01-22

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

Conditions

Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

Brief summary

Absolute change from baseline in QILD score [%] on HRCT at Week 26

Detailed description

Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26, Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26, Absolute change from baseline in vascular volume [%] on HRCT at Week 26, Absolute change from baseline in FVC [mL] at Week 26, Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at Week 26 at baseline, "Time to first supplemental oxygen use during the trial for oxygen non-users at baseline", Occurrence of infection-related AEs from baseline over the duration of the trial

Interventions

DRUGBI 1015550

DRUGPlacebo matching nerandomilast (BI 1015550)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in QILD score [%] on HRCT at Week 26	—

Secondary

Measure	Time frame
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26, Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26, Absolute change from baseline in vascular volume [%] on HRCT at Week 26, Absolute change from baseline in FVC [mL] at Week 26, Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at Week 26 at baseline, "Time to first supplemental oxygen use during the trial for oxygen non-users at baseline", Occurrence of infection-related AEs from baseline over the duration of the trial	—

Measure

Time frame

—

Countries

Austria, France, Germany, Italy, Netherlands, Norway, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026