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NCT04419506 · ClinicalTrials.gov registry record · Phase 2
A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT04419506: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04419506 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04419506, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study 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.
Primary Outcome
The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.
Interventions
- DRUG Placebo
- DRUG BI 1015550
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2021-10-15 |
| Phase | Phase 2 |
What the finished NCT04419506 record still lists
NCT04419506 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04419506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04419506 about?
NCT04419506 is a clinical study titled "A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)". 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 101555...
What is the current status of trial NCT04419506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2020-07-28. Estimated completion is 2021-10-15.
What interventions are being tested in trial NCT04419506?
The interventions under investigation include: Placebo (DRUG), BI 1015550 (DRUG).
Who is sponsoring clinical trial NCT04419506?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04419506's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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