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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,178 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05321082
The ClinicalTrials.gov registry entry for NCT05321082 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05321082 reports 0 study locations.
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.
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