Trial Outcomes & Findings for A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT04419506)
NCT ID: NCT04419506
Last Updated: 2022-11-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline (day 1) and week 12.
Results posted on
2022-11-01
Participant Flow
This was a trial with a randomised, placebo-controlled, double-blind, parallel-group design over 12 weeks, including a screening period of up to 44 days, a 12-week treatment period, and a 1-week follow-up period in patients with idiopathic pulmonary fibrosis (IPF) stratified by baseline antifibrotic treatment (Non-AF stratum: patients not on antifibrotic treatment at baseline; AF stratum: stable antifibrotic treatment with nintedanib or pirfenidone at baseline).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo - Antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
49
|
25
|
48
|
|
Overall Study
COMPLETED
|
25
|
39
|
25
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
10
|
0
|
5
|
Reasons for withdrawal
| Measure |
Placebo - Antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
10
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
poor-compliance
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Treated Set (TS): all patients who received at least one dose of trial drug.
Baseline characteristics by cohort
| Measure |
Placebo - Antifibrotics at Baseline
n=25 Participants
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
n=49 Participants
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
n=25 Participants
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
n=48 Participants
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
69.3 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
71.8 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
69.9 years
STANDARD_DEVIATION 8.3 • n=483 Participants
|
69.6 years
STANDARD_DEVIATION 8.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
113 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
134 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
115 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Forced vital capacity (FVC)
|
2690.000 Milliliter
STANDARD_DEVIATION 889.985 • n=93 Participants • Treated Set (TS): all patients who received at least one dose of trial drug.
|
2875.551 Milliliter
STANDARD_DEVIATION 752.818 • n=4 Participants • Treated Set (TS): all patients who received at least one dose of trial drug.
|
2864.920 Milliliter
STANDARD_DEVIATION 1015.104 • n=27 Participants • Treated Set (TS): all patients who received at least one dose of trial drug.
|
2782.938 Milliliter
STANDARD_DEVIATION 835.104 • n=483 Participants • Treated Set (TS): all patients who received at least one dose of trial drug.
|
2811.946 Milliliter
STANDARD_DEVIATION 845.625 • n=36 Participants • Treated Set (TS): all patients who received at least one dose of trial drug.
|
PRIMARY outcome
Timeframe: Baseline (day 1) and week 12.Population: Full Analysis Set (FAS): all patients who received at least one dose of trial drug and who had a baseline and at least one post-baseline measurement available for Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1) or Diffusion Capacity of the Lung for Carbon Monoxide (DLCO).
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.
Outcome measures
| Measure |
Placebo - Antifibrotics at Baseline
n=25 Participants
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
n=48 Participants
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
n=25 Participants
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
n=47 Participants
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
|---|---|---|---|---|
|
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
|
-77.70 Milliliter
Interval -124.87 to -30.53
|
2.72 Milliliter
Interval -33.46 to 38.89
|
-95.62 Milliliter
Interval -157.13 to -34.1
|
6.10 Milliliter
Interval -39.67 to 51.88
|
SECONDARY outcome
Timeframe: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.Population: Treated Set (TS): all patients who received at least one dose of trial drug.
The number of patients with any adverse event during the on-treatment period.
Outcome measures
| Measure |
Placebo - Antifibrotics at Baseline
n=25 Participants
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
n=49 Participants
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
n=25 Participants
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
n=48 Participants
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
|---|---|---|---|---|
|
The Number of Patients With Treatment Emergent Adverse Event
|
5 Participants
|
18 Participants
|
5 Participants
|
9 Participants
|
Adverse Events
Placebo - Antifibrotics at Baseline
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
BI 1015550 - Antifibrotics at Baseline
Serious events: 3 serious events
Other events: 24 other events
Deaths: 1 deaths
Placebo - Non-antifibrotics at Baseline
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1015550 - Non-antifibrotics at Baseline
Serious events: 3 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo - Antifibrotics at Baseline
n=25 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
n=49 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
n=25 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
n=48 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.1%
1/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
General disorders
Condition aggravated
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.1%
2/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.1%
1/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.1%
1/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.0%
1/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.1%
1/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.1%
1/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.0%
1/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
Other adverse events
| Measure |
Placebo - Antifibrotics at Baseline
n=25 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
BI 1015550 - Antifibrotics at Baseline
n=49 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.
|
Placebo - Non-antifibrotics at Baseline
n=25 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.
|
BI 1015550 - Non-antifibrotics at Baseline
n=48 participants at risk
Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.0%
1/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.1%
1/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
30.6%
15/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
8.0%
2/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
16.7%
8/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.1%
2/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
6.2%
3/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.1%
2/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
6.2%
3/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.0%
1/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
8.0%
2/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.2%
2/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
General disorders
Asthenia
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.0%
1/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
6.2%
3/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
General disorders
Fatigue
|
12.0%
3/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
2.0%
1/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.2%
2/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
8.2%
4/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
6.1%
3/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
6.2%
3/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
8.2%
4/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
4.0%
1/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
6.2%
3/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/49 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/25 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
0.00%
0/48 • From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Treated Set (TS): all patients who received at least one dose of trial drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER