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Nerandomilast in Children and Adolescents With Fibrosing Interstitial Lung Disease
NCT07366034Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Apr 2029
- Countries
- 22
- Sponsor
- Boehringer Ingelheim
- Drugs
- nerandomilast
- Conditions
- fibrosing interstitial lung disease (F-ILD)
01
Overview
Phase 3, randomised, double-blind trial of nerandomilast in fibrosing interstitial lung disease (F-ILD) (3 arms), sponsored by Boehringer Ingelheim. Primary endpoints: Area under the concentration curve at steady state at 28 weeks and Treatment-emergent adverse event at 26 weeks. Started Jul 2026; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Participants aged 2 to <6 years
Nerandomilast (open-label) in Part A and Part B
Participants aged 6 to <18 years, group 1
Nerandomilast (blinded) in Part A, Nerandomilast (open-label) in Part B
Participants aged 6 to <18 years, group 2
Placebo (blinded) in Part A, Nerandomilast (open-label) in Part B
03
Who it enrols
Children and adolescents 2 to <18 years old with fibrosing ILD, FVC % predicted >=25% (for >=6 years), and clinically significant disease. Excludes prior nerandomilast, recent PDE inhibitors or pirfenidone, unstable PAH, active vasculitis, suicidal behavior/ideation, and clinically significant depression.
04
Endpoints
Primary
Area under the concentration curve at steady state
Treatment-emergent adverse event
Secondary
Oxygen saturation
Height
Pediatric quality of life inventory
Treatment-emergent adverse event
Time to first respiratory-related hospitalisation
Time to first acute interstitial lung disease exacerbation or death
Time to death
Acceptability based on number/size of tablets
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