Nerandomilast
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim
Conditions
Familial Pulmonary FibrosisFibrosing Interstitial Lung DiseaseFibrosing interstitial lung diseaseHealthyHealthy volunteer trialIdiopathic Inflammatory MyopathiesIdiopathic Pulmonary FibrosisInterstitial Lung Abnormalities
Phase 1
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
CompletedNCT06139302
Start: 2023-12-20End: 2024-02-13Updated: 2025-12-01
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
CompletedNCT06393127
Start: 2024-06-04End: 2024-09-10Updated: 2025-12-01
Relative bioavailability of two different formulations of nerandomilast and investigation of the food effect on new formulation following oral administration in healthy adult male and female subjects (an open-label, randomised, single-dose, three-way crossover trial)
CompletedCTIS2024-511245-18-00
Start: 2024-10-11End: 2024-11-30Target: 15Updated: 2024-08-08
A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood
CompletedNCT07081932
Start: 2025-08-26End: 2025-10-08Updated: 2025-10-14
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood
CompletedNCT07100964
Start: 2025-08-11End: 2025-10-01Updated: 2025-10-14
Phase 3
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
RecruitingNCT06238622
Start: 2024-05-06End: 2027-05-05Target: 1700Updated: 2026-08-20
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
RecruitingNCT06806592
Start: 2025-09-13End: 2027-07-30Target: 400Updated: 2026-09-16
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
RecruitingNCT07201922
Start: 2026-02-10End: 2029-05-23Target: 80Updated: 2026-09-08
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
RecruitingNCT07366034
Start: 2026-07-21End: 2031-04-14Target: 35Updated: 2026-09-15
FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression
Not yet recruitingNCT07540988
Start: 2026-09-14End: 2028-12-12Target: 466Updated: 2026-09-03
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)
Not yet recruitingCTIS2025-523369-32-00
Target: 6Updated: 2026-07-07
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Not yet recruitingNCT07789015
Start: 2026-11-09End: 2030-03-26Target: 270Updated: 2026-09-16