Trial Outcomes & Findings for A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation (NCT NCT04656275)

Last Updated: 2024-11-27

Results Overview

Number of participants with drug-related adverse events (AEs) is presented. Participants with treatment-emergent drug-related Adverse Events (AEs) is reported.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

From drug administration until 12:00 AM on day after last administration of study drug + 7 days residual effect period (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks.

Results posted on

2024-11-27

Participant Flow

This was a randomised, double blind, placebo-controlled, parallel group design, to compare safety and tolerability of different doses of BI 1323495 with placebo and to assess pharmacodynamics of BI 1323495 in sputum and in blood as well as early signs of clinical efficacy of BI 1323495 in patients with non-cystic fibrosis bronchiectasis (nCFB).

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

Participant milestones
Measure	Part A: Placebo Bid This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Overall Study STARTED	2	5
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Placebo Bid This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Overall Study Study terminated by sponsor	2	4

Baseline Characteristics

Only patients with no missing values for absolute neutrophil elastase (NE) activity in sputum are reported.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Placebo Bid n=2 Participants This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=5 Participants 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Total n=7 Participants Total of all reporting groups
Age, Continuous	52.0 Years STANDARD_DEVIATION 8.5 • n=2 Participants	59.2 Years STANDARD_DEVIATION 5.3 • n=5 Participants	57.1 Years STANDARD_DEVIATION 6.6 • n=7 Participants
Sex: Female, Male Female	0 Participants n=2 Participants	3 Participants n=5 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=2 Participants	2 Participants n=5 Participants	4 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=2 Participants	5 Participants n=5 Participants	7 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) White	2 Participants n=2 Participants	5 Participants n=5 Participants	7 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Absolute neutrophil elastase (NE) activity in sputum	19115.0 Relative fluorescence unit (RFU) STANDARD_DEVIATION 598.2 • n=2 Participants • Only patients with no missing values for absolute neutrophil elastase (NE) activity in sputum are reported.	15610.4 Relative fluorescence unit (RFU) STANDARD_DEVIATION 9991.7 • n=4 Participants • Only patients with no missing values for absolute neutrophil elastase (NE) activity in sputum are reported.	16778.6 Relative fluorescence unit (RFU) STANDARD_DEVIATION 7952.8 • n=6 Participants • Only patients with no missing values for absolute neutrophil elastase (NE) activity in sputum are reported.
Neutrophil cell count in sputum	338.9 Neutrophils*10^9/Liter STANDARD_DEVIATION 40.7 • n=2 Participants • Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.	322.0 Neutrophils*10^9/Liter STANDARD_DEVIATION 123.9 • n=4 Participants • Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.	327.6 Neutrophils*10^9/Liter STANDARD_DEVIATION 98.0 • n=6 Participants • Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.
NE activity in whole blood after stimulation with zymosan, normalized to neutrophil counts	5354.8 RFU/(10^9 cells/L) STANDARD_DEVIATION 3506.7 • n=2 Participants	7278.5 RFU/(10^9 cells/L) STANDARD_DEVIATION 2574.4 • n=5 Participants	6728.9 RFU/(10^9 cells/L) STANDARD_DEVIATION 2710.9 • n=7 Participants
Absolute post-bronchodilator forced expiratory volume in one second, FEV1	3052.5 Milliliter (mL) STANDARD_DEVIATION 475.9 • n=2 Participants	2177.2 Milliliter (mL) STANDARD_DEVIATION 434.5 • n=5 Participants	2427.3 Milliliter (mL) STANDARD_DEVIATION 588.3 • n=7 Participants

PRIMARY outcome

Timeframe: From drug administration until 12:00 AM on day after last administration of study drug + 7 days residual effect period (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks.

Population: Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.

Number of participants with drug-related adverse events (AEs) is presented. Participants with treatment-emergent drug-related Adverse Events (AEs) is reported.

Outcome measures

Outcome measures
Measure	Part A: Placebo Bid n=2 Participants This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=5 Participants 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Number of Subjects With Drug-related Adverse Events (AEs)	0 Participants	2 Participants

SECONDARY outcome

Timeframe: At baseline Day -6, Day -2, Day 1 before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.

The change from baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in absolute neutrophil elastase (NE) activity in sputum is reported. The baseline value was calculated as the mean of the baseline values (at day -6, -2, day 1 predose). RFU is the standard output of a florescence reader. RFU (ex 360 nm, em460 nm).

Outcome measures

Outcome measures
Measure	Part A: Placebo Bid n=2 Participants This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=5 Participants 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum Change from baseline to Day 15	3301.0 Relative fluorescence unit (RFU)	-156.9 Relative fluorescence unit (RFU) Standard Deviation 2028.5
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum Change from baseline to Day 29	2745.0 Relative fluorescence unit (RFU)	-194.4 Relative fluorescence unit (RFU) Standard Deviation 660.6
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum Change from baseline to Day 57	—	-497.1 Relative fluorescence unit (RFU) Standard Deviation 217.9
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum Change from baseline to Day 78	1665.0 Relative fluorescence unit (RFU)	—
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum Change from baseline to Day 82	—	383.0 Relative fluorescence unit (RFU)
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum Change from baseline to Day 98	—	582.3 Relative fluorescence unit (RFU) Standard Deviation 1257.7

SECONDARY outcome

Timeframe: At baseline Day -6, Day -2, Day 1 before the first dose and at at Week 2, Week 4, Week 8, Week 12 during treatment.

The change from baseline to week 12 (at Week 2, Week 4, Week 8, Week 12) in absolute neutrophil cell count in sputum is reported. The baseline value was calculated as the mean of the baseline values (at day -6, -2, day 1 predose). RFU: Relative fluorescence unit

Outcome measures

Outcome measures
Measure	Part A: Placebo Bid n=2 Participants This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=4 Participants 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum Time-matched change from baseline to Week 2	-9.7 Neutrophils*10^9/Liter	27.1 Neutrophils*10^9/Liter Standard Deviation 82.9
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum Time-matched change from baseline to Week 4	16.8 Neutrophils*10^9/Liter	-7.8 Neutrophils*10^9/Liter Standard Deviation 11.3
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum Time-matched change from baseline to Week 8	—	9.7 Neutrophils*10^9/Liter Standard Deviation 23.4
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum Time-matched change from baseline to Week 12	-47.7 Neutrophils*10^9/Liter	69.5 Neutrophils*10^9/Liter

SECONDARY outcome

Timeframe: At baseline Day 1, 2.5 hours (hrs) before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.

The change of NE activity from baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in whole blood after stimulation with zymosan (normalized to neutrophil counts) is reported. Relative fluorescence unit (RFU) is the standard output of a florescence reader. RFU (ex 360 nm, em460 nm).

Outcome measures

Outcome measures
Measure	Part A: Placebo Bid n=2 Participants This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=5 Participants 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) Time-matched change from baseline to Day 15	95.8 RFU/(10^9 cells/L)	-7733.9 RFU/(10^9 cells/L) Standard Deviation 2153.2
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) Time-matched change from baseline to Day 29 / -2:30	99.2 RFU/(10^9 cells/L)	-6306.0 RFU/(10^9 cells/L) Standard Deviation 852.6
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) Time-matched change from baseline to Day 29 / 6:00	238.1 RFU/(10^9 cells/L)	-6649.6 RFU/(10^9 cells/L) Standard Deviation 1505.1
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) Time-matched change from baseline to Day 57	-630.3 RFU/(10^9 cells/L)	-5889.9 RFU/(10^9 cells/L) Standard Deviation 786.0
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) Time-matched change from baseline to Day 82	-622.6 RFU/(10^9 cells/L) Standard Deviation 1089.0	-5689.9 RFU/(10^9 cells/L) Standard Deviation 3610.3
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) Time-matched change from baseline to Day 98	-326.4 RFU/(10^9 cells/L) Standard Deviation 1295.0	1221.1 RFU/(10^9 cells/L) Standard Deviation 2703.8

SECONDARY outcome

Timeframe: At baseline Day -2 before the first dose and at at Week 2, Week 8, Week 12 during treatment.

The change from baseline to week 12 (at Week 2, Week 8, Week 12) in absolute post-bronchodilator forced expiratory volume in one second (FEV1).

Outcome measures

Outcome measures
Measure	Part A: Placebo Bid n=2 Participants This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=5 Participants 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 Time-matched change from baseline to Week 2	38 Milliliter (mL) Standard Deviation 113.1	1.4 Milliliter (mL) Standard Deviation 78.6
Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 Time-matched change from baseline to Week 8	-27.0 Milliliter (mL)	1.0 Milliliter (mL) Standard Deviation 220.1
Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 Time-matched change from baseline to Week 12	-138.0 Milliliter (mL)	-40.0 Milliliter (mL) Standard Deviation 178.2

Adverse Events

Part A: Placebo Bid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part A: 30 mg BI 1323495 Bid

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A: Placebo Bid n=2 participants at risk This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.	Part A: 30 mg BI 1323495 Bid n=5 participants at risk 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour.
Cardiac disorders Bradycardia	0.00% 0/2 • From drug administration until 12:00 AM on day after last administration of study drug + 7 days (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks. All-cause mortality: Up to 13 weeks. Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.	20.0% 1/5 • Number of events 1 • From drug administration until 12:00 AM on day after last administration of study drug + 7 days (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks. All-cause mortality: Up to 13 weeks. Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • From drug administration until 12:00 AM on day after last administration of study drug + 7 days (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks. All-cause mortality: Up to 13 weeks. Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.	20.0% 1/5 • Number of events 1 • From drug administration until 12:00 AM on day after last administration of study drug + 7 days (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks. All-cause mortality: Up to 13 weeks. Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.

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