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NCT05321069 · ClinicalTrials.gov registry record · Phase 3
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study of Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,177
- Enrollment target
- 20
- Study locations
NCT05321069: Completed Phase 3 study of Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.
NCT05321069 is a Phase 3 study of Idiopathic Pulmonary Fibrosis that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,177 participants, above the 728-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05321069, a Phase 3 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,177 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, 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 IPF. 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) \[mL\] at Week 52 is reported. The absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covar
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI 1015550
Study Locations (20)
Florida
- St. Francis Medical Institute - Clearwater
- University of Florida Health Shands Hospital - Gainesville
- Clinical Research Specialists LLC - Kissimmee
- Advanced Pulmonary Research Institute - Loxahatchee Groves
- Destin Pulmonary Critical Care - Santa Rosa Beach
California
- University of Southern California - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- University of California Los Angeles - Los Angeles
- University of California Davis - Sacramento
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- National Jewish Health - Denver
Connecticut
- Yale University School of Medicine - New Haven
Delaware
- Christiana Hospital - Newark
District of Columbia
- Georgetown University - Washington D.C.
Georgia
- Piedmont Healthcare-Atlanta-57055 - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,177 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2024-12-17 |
| Phase | Phase 3 |
What the finished NCT05321069 record still lists
NCT05321069 is an interventional study that assigns participants to a tested intervention. Its 1,177 participants enrollment target places it among the larger protocols in the corpus, above the 728-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (62% higher).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05321069 names 20 study sites across 13 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05321069 about?
NCT05321069 is a clinical study titled "A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)". This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find o...
What is the current status of trial NCT05321069?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,177 participants. The study started on 2022-10-06. Estimated completion is 2024-12-17.
What conditions does trial NCT05321069 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT05321069?
The interventions under investigation include: Placebo (DRUG), BI 1015550 (DRUG).
Who is sponsoring clinical trial NCT05321069?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05321069 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05321069's enrollment target sits among peer trials
1,177 6th of 51 higher than 46 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis 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.
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