A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI 1015550 low dose
|
Drug: BI 1015550
BI 1015550
|
| Experimental: BI 1015550 high dose
|
Drug: BI 1015550
BI 1015550
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52 [at baseline, at week 52]
Secondary Outcome Measures
- Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial [up to 30 months]
Key secondary endpoint
- Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trial [up to 30 months]
- Time to hospitalization for respiratory cause or death over the duration of trial [up to 30 months]
- Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial [up to 30 months]
- Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial [up to 30 months]
- Time to death over the duration of trial [up to 30 months]
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 [at baseline, at week 52]
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52 [at baseline, at week 52]
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52 [at baseline, at week 52]
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
- Absolute change from baseline in FVC % predicted at Week 52 [at baseline, at week 52]
- Absolute change from baseline in DLCO % predicted at Week 52 [at baseline, at week 52]
Eligibility Criteria
Criteria
Inclusion criteria
-
Patients ≥40 years old at the time of signed informed consent.
-
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
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Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
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Patients may be either:
-
on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks.)
-
not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
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Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
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Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) corrected for Haemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1.
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Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions.
Exclusion criteria
-
Relevant airways obstruction (prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7) at Visit 1.
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In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
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Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
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Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
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Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).
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Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
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Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
-
Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x Upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1.
Further exclusion criteria apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1305-0014