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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally

    Summary
    EudraCT number
    2019-004167-45
    Trial protocol
    FI   NL   DK   CZ   DE   HU   GB   AT   PL   SK   GR   IT  
    Global end of trial date
    15 Oct 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Oct 2022
    First version publication date
    21 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1305-0013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04419506
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 001
    Public contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in forced vital capacity (FVC) in patients with Idiopathic Pulmonary Fibrosis (IPF). To investigate the safety and tolerability of BI 1015550 in patients with IPF.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    China: 10
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Finland: 15
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Japan: 24
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Ukraine: 11
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 27
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Australia: 2
    Worldwide total number of subjects
    233
    EEA total number of subjects
    105
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    48
    From 65 to 84 years
    179
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    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.

    Pre-assignment
    Screening details
    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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Patients, investigators, central reviewers, and everyone involved in trial conduct or analysis (except bioanalytics and possibly Data Monitoring Committee members) or with any other interest in this double-blind trial, remained blinded with regard to the randomised treatment assignments until after database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo - Antifibrotics at baseline
    Arm description
    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.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Arm title
    BI 1015550 - Antifibrotics at baseline
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    BI 1015550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Arm title
    Placebo - Non-antifibrotics at baseline
    Arm description
    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.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Arm title
    BI 1015550 - Non-antifibrotics at baseline
    Arm description
    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.
    Arm type
    Experimental

    Investigational medicinal product name
    BI 1015550
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Number of subjects in period 1 [1]
    Placebo - Antifibrotics at baseline BI 1015550 - Antifibrotics at baseline Placebo - Non-antifibrotics at baseline BI 1015550 - Non-antifibrotics at baseline
    Started
    25
    49
    25
    48
    Completed
    25
    39
    25
    43
    Not completed
    0
    10
    0
    5
         Consent withdrawn by subject
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    10
    -
    3
         Poor compliance
    -
    -
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 233 enrolled subjects, 147 subjects were randomized.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo - Antifibrotics at baseline
    Reporting group description
    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.

    Reporting group title
    BI 1015550 - Antifibrotics at baseline
    Reporting group description
    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.

    Reporting group title
    Placebo - Non-antifibrotics at baseline
    Reporting group description
    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.

    Reporting group title
    BI 1015550 - Non-antifibrotics at baseline
    Reporting group description
    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.

    Reporting group values
    Placebo - Antifibrotics at baseline BI 1015550 - Antifibrotics at baseline Placebo - Non-antifibrotics at baseline BI 1015550 - Non-antifibrotics at baseline Total
    Number of subjects
    25 49 25 48 147
    Age categorical
    Treated Set (TS): all patients who received at least one dose of trial drug.
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    10 7 3 11 31
        From 65-84 years
    14 42 22 35 113
        85 years and over
    1 0 0 2 3
    Age Continuous
    Treated Set (TS): all patients who received at least one dose of trial drug.
    Units: years
        arithmetic mean (standard deviation)
    67.5 ± 10.7 69.3 ± 6.6 71.8 ± 9.3 69.9 ± 8.3 -
    Sex: Female, Male
    Treated Set (TS): all patients who received at least one dose of trial drug.
    Units: Participants
        Female
    7 5 8 14 34
        Male
    18 44 17 34 113
    Race (NIH/OMB)
    Treated Set (TS): all patients who received at least one dose of trial drug.
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0
        Asian
    4 12 4 12 32
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0
        Black or African American
    0 0 0 0 0
        White
    21 37 21 36 115
        More than one race
    0 0 0 0 0
        Unknown or Not Reported
    0 0 0 0 0
    Ethnicity (NIH/OMB)
    Treated Set (TS): all patients who received at least one dose of trial drug.
    Units: Subjects
        Hispanic or Latino
    1 3 4 5 13
        Not Hispanic or Latino
    24 46 21 43 134
        Unknown or Not Reported
    0 0 0 0 0
    Forced vital capacity (FVC)
    Forced vital capacity (FVC) at baseline. FVC is the total amount of air exhaled during a Forced expiratory volume (FEV) test. Treated Set (TS): all patients who received at least one dose of trial drug.
    Units: Milliliter
        arithmetic mean (standard deviation)
    2690.000 ± 889.985 2875.551 ± 752.818 2864.920 ± 1015.104 2782.938 ± 835.104 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo - Antifibrotics at baseline
    Reporting group description
    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.

    Reporting group title
    BI 1015550 - Antifibrotics at baseline
    Reporting group description
    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.

    Reporting group title
    Placebo - Non-antifibrotics at baseline
    Reporting group description
    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.

    Reporting group title
    BI 1015550 - Non-antifibrotics at baseline
    Reporting group description
    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.

    Primary: The change from baseline in Forced vital capacity (FVC) at 12 weeks

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    End point title
    The change from baseline in Forced vital capacity (FVC) at 12 weeks
    End point description
    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. 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).
    End point type
    Primary
    End point timeframe
    Baseline (day 1) and week 12.
    End point values
    Placebo - Antifibrotics at baseline BI 1015550 - Antifibrotics at baseline Placebo - Non-antifibrotics at baseline BI 1015550 - Non-antifibrotics at baseline
    Number of subjects analysed
    25 [1]
    48 [2]
    25 [3]
    47 [4]
    Units: Milliliter
        arithmetic mean (confidence interval 95%)
    -77.70 (-124.87 to -30.53)
    2.72 (-33.46 to 38.89)
    -95.62 (-157.13 to -34.10)
    6.10 (-39.67 to 51.88)
    Notes
    [1] - Mean and confidence interval are adjusted
    [2] - Mean and confidence interval are adjusted
    [3] - Mean and confidence interval are adjusted
    [4] - Mean and confidence interval are adjusted
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.
    Comparison groups
    Placebo - Non-antifibrotics at baseline v BI 1015550 - Non-antifibrotics at baseline
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    [5]
    Method
    Parameter type
    Posterior difference
    Point estimate
    88.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    29.5
         upper limit
    154.2
    Notes
    [5] - Difference calculated as BI 1015550 - Placebo
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.
    Comparison groups
    Placebo - Antifibrotics at baseline v BI 1015550 - Antifibrotics at baseline
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    [6]
    Method
    Parameter type
    Adjusted mean difference
    Point estimate
    62.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.3
         upper limit
    125.5
    Notes
    [6] - Difference calculated as BI 1015550 - Placebo

    Secondary: The number of patients with treatment emergent adverse event

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    End point title
    The number of patients with treatment emergent adverse event
    End point description
    The number of patients with any adverse event during the on-treatment period. Treated Set (TS): all patients who received at least one dose of trial drug.
    End point type
    Secondary
    End point timeframe
    From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
    End point values
    Placebo - Antifibrotics at baseline BI 1015550 - Antifibrotics at baseline Placebo - Non-antifibrotics at baseline BI 1015550 - Non-antifibrotics at baseline
    Number of subjects analysed
    25
    49
    25
    48
    Units: Participants
    5
    18
    5
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
    Adverse event reporting additional description
    Treated Set (TS): all patients who received at least one dose of trial drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo, Antifibrotics at baseline
    Reporting group description
    Idiopathic pulmonary fibrosis (IPF) patients on stable 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 stable background therapy of nintedanib or prifenidone.

    Reporting group title
    Placebo, Non-antifibrotics at baseline
    Reporting group description
    Idiopathic pulmonary fibrosis (IPF) patients not on stable 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.

    Reporting group title
    BI 1015550, Non-antifibrotics at baseline
    Reporting group description
    Idiopathic pulmonary fibrosis (IPF) patients not on stable 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 not on background antifibrotic treatment at baseline. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.

    Reporting group title
    BI 1015550, Antifibrotics at baseline
    Reporting group description
    Idiopathic pulmonary fibrosis (IPF) patients on stable 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 stable background therapy of nintedanib or prifenidone.

    Serious adverse events
    Placebo, Antifibrotics at baseline Placebo, Non-antifibrotics at baseline BI 1015550, Non-antifibrotics at baseline BI 1015550, Antifibrotics at baseline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    5 / 25 (20.00%)
    3 / 48 (6.25%)
    3 / 49 (6.12%)
         number of deaths (all causes)
    0
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Vasculitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Peripheral nerve paresis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo, Antifibrotics at baseline Placebo, Non-antifibrotics at baseline BI 1015550, Non-antifibrotics at baseline BI 1015550, Antifibrotics at baseline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 25 (40.00%)
    5 / 25 (20.00%)
    18 / 48 (37.50%)
    24 / 49 (48.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    3 / 48 (6.25%)
    3 / 49 (6.12%)
         occurrences all number
    1
    0
    5
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 48 (6.25%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    3
    1
    Fatigue
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 25 (4.00%)
    2 / 48 (4.17%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    3
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
    1 / 48 (2.08%)
    1 / 49 (2.04%)
         occurrences all number
    2
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 25 (8.00%)
    8 / 48 (16.67%)
    15 / 49 (30.61%)
         occurrences all number
    7
    4
    9
    16
    Dyspepsia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    3 / 48 (6.25%)
    2 / 49 (4.08%)
         occurrences all number
    1
    0
    3
    2
    Flatulence
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    3 / 48 (6.25%)
    2 / 49 (4.08%)
         occurrences all number
    1
    1
    3
    2
    Nausea
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
    2 / 48 (4.17%)
    1 / 49 (2.04%)
         occurrences all number
    0
    2
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
    3 / 48 (6.25%)
    4 / 49 (8.16%)
         occurrences all number
    2
    1
    3
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 48 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    0
    0
    0
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 May 2020
    In this revision of the Clinical Trial Protocol (CTP), the dose and regimen of trial drug were deleted from the title to fulfil internal rules of disclosure.
    02 Jun 2020
    In this revision of the Clinical Trial Protocol (CTP), the table of risks was updated so that the risks associated with blood sampling, High-Resolution Computed Tomography (HRCT) and lung measurements (Pulmonary Function Test (PFT) and Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)), as well as the risk and mitigation plan for placebo use, were legible. The procedures in case of acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation were clarified. The description of Electrocardiogram (ECG) recording was corrected to remove the postdose ECG at Visit 2 and to clarify that triplicate ECGs were not expected (single ECG were to be performed). Regarding the optional substudy on digital lung auscultation test, fewer points of auscultations were to be used and the results were not meant to be reported in the Clinical Trial Report (CTR). Regarding the optional substudy on 24-hour cough measurements, an inclusion criterion to enter the substudy was added to ensure that participants coughed enough; the evaluations to be performed were clarified.
    09 Sep 2020
    In this revision of the Clinical Trial Protocol (CTP), the trial-related risks were updated to add the risk assessment due to the Coronavirus Disease 2019 (COVID-19) pandemic. An exclusion criterion was added to exclude patients with a Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection as this was a potential additional risk. The criteria to discontinue trial treatment were updated to include the patients who meet Adverse Event of Special Interest (AESI) definition of hepatic injury and the patients who experience infection with SARS-CoV-2 (for safety reasons).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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