NCT04419506

A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study. The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks. After 1 month of treatment, they visit the study site every 4 weeks. The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day. The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	BI 1015550	18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.
DRUG	Placebo	placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.

Timeline

• Start date: 2020-07-28
• Primary completion: 2021-10-06
• Completion: 2021-10-15
• First posted: 2020-06-05
• Last updated: 2022-11-01
• Results posted: 2022-11-01

Locations

75 sites across 22 countries: United States, Argentina, Australia, Austria, Canada, Chile, China, Czechia, Denmark, Finland, Germany, Greece, Hungary, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study