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NCT05321082 · ClinicalTrials.gov registry record · Phase 3
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,178
- Enrollment target
NCT05321082: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT05321082 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,178 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05321082, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,178 participants
- Enrollment target
Study 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.
Primary Outcome
The absolute change from baseline in forced vital capacity (FVC) in milliliters \[mL\] at Week 52 is reported. The absolute change from baseline in FVC was analyzed by a restricted maximum likelihood (REML)-based mixed model with repeated measurements (MMRM) comparing the change from baseline in FVC at Week 52 between treatment groups. The analysis included the fixed, categorical effects of treatment, baseline intake of antifibrotic (AF) treatment, and baseline High-resolution Computed Tomograph
Interventions
- DRUG Placebo
- DRUG BI 1015550
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,178 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 3 |
What the finished NCT05321082 record still lists
NCT05321082 is an interventional study that assigns participants to a tested intervention. Its 1,178 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05321082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05321082 about?
NCT05321082 is a clinical study titled "A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)". 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 st...
What is the current status of trial NCT05321082?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,178 participants. The study started on 2022-11-16. Estimated completion is 2025-04-14.
What interventions are being tested in trial NCT05321082?
The interventions under investigation include: Placebo (DRUG), BI 1015550 (DRUG).
Who is sponsoring clinical trial NCT05321082?
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 NCT05321082's enrollment target sits among peer trials
1,178 235th of 2000 higher than 1,766 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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