NCT05321082

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,178 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	BI 1015550	Participants received film-coated nerandomilast tablets orally, twice daily, at doses of either 9 mg or 18 mg, in the morning and in the evening.
DRUG	Placebo	Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally, twice daily, in the morning and in the evening.

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-12-18
• Completion: 2025-04-14
• First posted: 2022-04-11
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

400 sites across 45 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study