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Clinical trial

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)

NCT07366034 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Boehringer Ingelheim
Phase
Phase 3
Overall status
Recruiting
Start date
July 21, 2026
Completion date
April 14, 2031
Enrollment
35 (estimated)
Sites
47

Conditions

As the registry lists them; a condition with its own page is linked.

fibrosing interstitial lung disease