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    Clinical Trial Results:
    A subject and investigator blinded, randomized, placebo-controlled, repeat-dose, multicenter study to investigate efficacy, safety, and tolerability of CMK389 in patients with chronic pulmonary sarcoidosis

    Summary
    EudraCT number
    		 2018-000381-11
    Trial protocol
    		 DE   GB   DK   CZ   PL  
    Global end of trial date
    12 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2024
    First version publication date
    25 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCMK389X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04064242
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, novartis.email@novartis.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
    12 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the efficacy of CMK389 in participants with chronic pulmonary sarcoidosis.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 Participants were required to be on either Methotrexate or Azathioprine (no dose requirement) and on 5-15mg/day of prednisone for at least 6 months prior to screening. Methotrexate/Azathioprine was discontinued in the Run-In period and prednisone was titrated during the trial. Hydroxychloroquine was allowed but not required during the trial.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    62
    EEA total number of subjects
    47
    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)
    59
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 22 investigative sites in 6 countries.

    Pre-assignment
    Screening details
    		 After obtaining signed informed consent, a screening epoch of 28 days was used to assess subject eligibility.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CMK389 10 mg/kg i.v.
    Arm description
    		 CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    CMK389
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses

    Arm title
    		 Placebo i.v.
    Arm description
    		 Placebo i.v. every 4 weeks for a total of 4 doses
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo i.v. every 4 weeks for a total of 4 doses

    Number of subjects in period 1
    		CMK389 10 mg/kg i.v. Placebo i.v.
    Started
    31
    31
    Completed
    31
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CMK389 10 mg/kg i.v.
    Reporting group description
    		 CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo i.v. every 4 weeks for a total of 4 doses

    Reporting group values
    		 CMK389 10 mg/kg i.v. Placebo i.v. Total
    Number of subjects
    		 31 31 62
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 29 30 59
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.5 ( 8.69 ) 50.7 ( 9.36 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 7 13 20
        Male
    		 24 18 42
    Race/Ethnicity, Customized
    Units: Subjects
        Black Or African American
    		 3 2 5
        Unknown
    		 0 1 1
        White
    		 28 28 56

    End points

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    End points reporting groups
    Reporting group title
    CMK389 10 mg/kg i.v.
    Reporting group description
    		 CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses

    Reporting group title
    Placebo i.v.
    Reporting group description
    		 Placebo i.v. every 4 weeks for a total of 4 doses

    Primary: Change in percent predicted FVC from baseline to 16 weeks of treatment

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    End point title
    		 Change in percent predicted FVC from baseline to 16 weeks of treatment
    End point description
    To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    26
    27
    Units: Percent predicted
        arithmetic mean (standard deviation)
    -0.48 ( 1.17 )
    1.02 ( 1.13 )
    Statistical analysis title
    		 Percent predicted FVC
    Comparison groups
    CMK389 10 mg/kg i.v. v Placebo i.v.
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.1804
    Method
    		 Bayesian analysis
    Parameter type
    		 Posterior estimate treatment difference
    Point estimate
    -1.49
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -3.56
         upper limit
    		 0.6
    Variability estimate
    Standard deviation
    Dispersion value
    1.62
    Notes
    [1] - A Bayesian model for repeated measurements including data collected at Weeks 4, 8, 12 and 16 was applied to compare FVC between CMK389 and placebo groups.

    Secondary: Number of participants who had an increase in steroid usage from baseline to 16 weeks of treatment

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    End point title
    		 Number of participants who had an increase in steroid usage from baseline to 16 weeks of treatment
    End point description
    The Clinical Status Evaluation (CSE) served as a safety evaluation and served to establish the patient's clinical status (Clinical Status Determination [CSD]). CSE was performed prior to the titration of steroids, and the CSD guided selection of the next dose of steroids. Participants with CSD of "improved" or "stable" decreased steroid dose by 1 step on the dosing scale. Participants with CSD of "deteriorating" were ineligible to continue the study (if found during the run-in epoch or at study Day 1); or they increased steroid dose by 1 step (if found during the treatment epoch).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    29
    31
    Units: participants
    5
    4
    No statistical analyses for this end point

    Secondary: Number of participants who deteriorate from baseline to 16 weeks of treatment

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    End point title
    		 Number of participants who deteriorate from baseline to 16 weeks of treatment
    End point description
    Composite index of pulmonary physiology (CIPP) and exercise capacity: a participant who deteriorated from baseline to each visit was defined as a patient with: relative reduction if FVC ≥ 10%, or relative reduction if FEV1 ≥ 10%, or relative reduction of DLCO ≥ 15%, or relative reduction of 6MWD ≥ 50 m.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    29
    31
    Units: participants
    9
    10
    No statistical analyses for this end point

    Secondary: Percent change in [18F]-FDG-PET/CT (SUVmax and SUVmean) from baseline to 16 weeks of treatment

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    End point title
    		 Percent change in [18F]-FDG-PET/CT (SUVmax and SUVmean) from baseline to 16 weeks of treatment
    End point description
    [18F]-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) maximum standardized uptake value and mean standardized uptake value (SUVmax and SUVmean) imaging was used to assess potential anti-inflammatory effects by CMK389 on the sarcoidosis process. All participants underwent whole-body head to mid-thigh [18F]FDG-PET/CT imaging state-of-the-art, 3D PET/CT scanners with a reconstructed resolution of ≤5 mm. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    29
    31
    Units: percent change from Baseline
    least squares mean (standard error)
        Lung Parenchyma SUVmax (n=12,18)
    -29.23 ( 31.128 )
    26.78 ( 24.461 )
        Lymph Nodes SUVmax (n=11,9)
    -23.40 ( 9.083 )
    -16.48 ( 9.759 )
        Extrathoracic SUVmax (n=4,13)
    -12.89 ( 14.361 )
    -19.07 ( 6.908 )
        Lung Parenchyma SUVmean (n=12,18)
    -34.06 ( 28.626 )
    20.74 ( 22.443 )
        Lymph Nodes SUVmean (n=11,9)
    -30.83 ( 8.157 )
    -22.75 ( 9.101 )
        Extrathoracic SUVmean (n=4,13)
    -11.23 ( 13.020 )
    -23.99 ( 6.440 )
    No statistical analyses for this end point

    Secondary: The observed serum concentration following CMK389 administration at end of infusion

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    End point title
    		 The observed serum concentration following CMK389 administration at end of infusion [2]
    End point description
    Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Post 1 hour: Day 1, Day 29, Day 57, Day 85
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only applicable to CMK389 arm.
    End point values
    		 CMK389 10 mg/kg i.v.
    Number of subjects analysed
    31
    Units: ng/mL
    median (full range (min-max))
        Day 1 (n=30)
    453000 (236000 to 1230000)
        Day 29 (n=31)
    533000 (58100 to 2460000)
        Day 57 (n=29)
    571000 (77600 to 3070000)
        Day 85 (n=28)
    541000 (78300 to 893000)
    No statistical analyses for this end point

    Secondary: Pre-dose trough concentration (Ctrough) of CMK389

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    End point title
    		 Pre-dose trough concentration (Ctrough) of CMK389 [3]
    End point description
    Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of a dosing interval. The Number of Subjects Analyzed differs as stated on the category column, in case of difference from Number of subjects that started the Arm.
    End point type
    Secondary
    End point timeframe
    Pre-dose: Day 1, Day 29, Day 57, Day 85
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only applicable to CMK389 arm.
    End point values
    		 CMK389 10 mg/kg i.v.
    Number of subjects analysed
    31
    Units: ng/mL
    median (full range (min-max))
        Day 1 (n=15)
    0.00 (0.00 to 619000)
        Day 29 (n=31)
    83500 (43300 to 176000)
        Day 57 (n=30)
    105000 (41700 to 182000)
        Day 85 (n=30)
    125000 (27900 to 444000)
    No statistical analyses for this end point

    Secondary: Change in FEV1 from baseline to 16 weeks of treatment

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    End point title
    		 Change in FEV1 from baseline to 16 weeks of treatment
    End point description
    FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The least-squares means for change from baseline in FEV1 to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in pre-dose FEV1 is considered a favourable outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    26
    27
    Units: liters (L)
        least squares mean (standard error)
    -0.03 ( 0.033 )
    0.00 ( 0.032 )
    Statistical analysis title
    		 FEV1
    Comparison groups
    CMK389 10 mg/kg i.v. v Placebo i.v.
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.783
    Method
    		 Mixed effects Model for Repeated Measure
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.04
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.045

    Secondary: Change in diffusion capacity of the lung for carbon monoxide (DLCO) from baseline to 16 weeks of treatment

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    End point title
    		 Change in diffusion capacity of the lung for carbon monoxide (DLCO) from baseline to 16 weeks of treatment
    End point description
    DLCO is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. The least squares means for change from baseline in DLCO to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in DLCO is considered a favourable outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    20
    25
    Units: mL/min/mmHg
        least squares mean (standard error)
    -0.58 ( 0.493 )
    -0.40 ( 0.448 )
    Statistical analysis title
    		 DLCO
    Comparison groups
    CMK389 10 mg/kg i.v. v Placebo i.v.
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.608
    Method
    		 Mixed effects Model for Repeated Measure
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.18
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 0.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.664

    Secondary: Change in 6-minute walk distance (6MWD) from baseline to 16 weeks of treatment

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    End point title
    		 Change in 6-minute walk distance (6MWD) from baseline to 16 weeks of treatment
    End point description
    The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters. The least squares means for change from baseline in 6MWD to assess the effect of CMK389 compared to placebo after 16 weeks were obtained from a mixed effects model for repeated measures (MMRM). A positive change from baseline in 6MWD is considered a favourable outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 CMK389 10 mg/kg i.v. Placebo i.v.
    Number of subjects analysed
    26
    26
    Units: meters
        least squares mean (standard error)
    11.21 ( 9.470 )
    10.50 ( 9.223 )
    Statistical analysis title
    		 6MWD
    Comparison groups
    CMK389 10 mg/kg i.v. v Placebo i.v.
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.479
    Method
    		 Mixed effects Model for Repeated Measure
    Parameter type
    		 Median difference (net)
    Point estimate
    0.71
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -16.35
         upper limit
    		 17.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    13.126

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 197 days..
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    CMK389
    Reporting group description
    		 CMK389

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 CMK389 Placebo Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    2 / 62 (3.23%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CMK389 Placebo Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 31 (67.74%)
    19 / 31 (61.29%)
    40 / 62 (64.52%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    2
    Lipase increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    0
    2
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 31 (3.23%)
    3 / 62 (4.84%)
         occurrences all number
    2
    1
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    4 / 62 (6.45%)
         occurrences all number
    3
    2
    5
    Headache
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 31 (12.90%)
    6 / 62 (9.68%)
         occurrences all number
    2
    4
    6
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    4 / 62 (6.45%)
         occurrences all number
    3
    1
    4
    Fatigue
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 31 (12.90%)
    8 / 62 (12.90%)
         occurrences all number
    4
    6
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    4 / 62 (6.45%)
         occurrences all number
    3
    1
    4
    Diarrhoea
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    3 / 62 (4.84%)
         occurrences all number
    1
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Pulmonary sarcoidosis
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 31 (3.23%)
    3 / 62 (4.84%)
         occurrences all number
    2
    1
    3
    Cough
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 31 (12.90%)
    6 / 62 (9.68%)
         occurrences all number
    2
    4
    6
    Dyspnoea
         subjects affected / exposed
    4 / 31 (12.90%)
    3 / 31 (9.68%)
    7 / 62 (11.29%)
         occurrences all number
    4
    4
    8
    Skin and subcutaneous tissue disorders
    Cutaneous sarcoidosis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    0
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 31 (12.90%)
    8 / 62 (12.90%)
         occurrences all number
    5
    4
    9
    Back pain
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 31 (3.23%)
    4 / 62 (6.45%)
         occurrences all number
    3
    1
    4
    Myalgia
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    3 / 62 (4.84%)
         occurrences all number
    1
    2
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 31 (9.68%)
    4 / 31 (12.90%)
    7 / 62 (11.29%)
         occurrences all number
    3
    4
    7
    Nasopharyngitis
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    4 / 62 (6.45%)
         occurrences all number
    3
    2
    5
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 31 (6.45%)
    6 / 62 (9.68%)
         occurrences all number
    4
    2
    6
    Urinary tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    3 / 31 (9.68%)
    4 / 62 (6.45%)
         occurrences all number
    1
    3
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2019
    The purpose of this amendment was to make operational changes to the visit design to reduce patient and site burden as well as to clarify the procedure in case of premature discontinuation.
    17 Sep 2019
    The purpose of this amendment was to make changes to the inclusion criteria and is based on feedback from sites regarding feasibility. The update Inclusion criteria #7 is expected to improve the recruitment rate since lower doses of prednisone (or equivalent) are more common in clinical practice. Now, in the absence of higher prednisone doses, Inclusion criteria #8 has been added as a marker of clinically significant disease
    11 Dec 2019
    The purpose of this amendment was to answer to comments from the U.S. Food and Drug Administration (FDA) to add clarifying statements to the exclusion criteria, specify a more objective grading scale for the reporting of Adverse Events, and add instructions for monitoring an adverse event of special interest (hypersensitivity reactions).
    17 Apr 2020
    The purpose of this amendment was to answer to comments received from the Paul-Ehrlich-Institut (PEI) in Germany.
    20 Jul 2020
    The purpose of this amendment was to answer to comments received from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom
    01 Apr 2021
    The main purpose of this amendment was to revise the inclusion/ exclusion criteria to allow for facilitated recruitment in line with the study rational, and clarify trial conduct. Age and BMI limits are expanded. Inclusion criteria #6 has been clarified to be in line with the study rationale and to include patients with <15% extent of fibrosis instead of <15% reticulation. Pregnancy follow up was re-assessed based on predicted time for IL-18 levels to return within the normal range in healthy volunteers and reduced to 8 weeks after EOS (i.e., 24 weeks after last study treatment). Rescreening is now permitted. The restriction period for administration of live/attenuated vaccines prior to CMK389 treatment is reduced from 3 months to 1 month. The immune response of the vaccine would already be very high and it is therefore expected to have a low risk of any negative impact on either the efficacy or safety profile of the vaccine.
    11 Aug 2021
    The main purpose of this amendment was to include Patient Reported Outcomes (PROs) assessments and update the list of eligibility criteria. PROs are added to the protocol to collect more information about health-related quality of life and health status in interstitial lung diseases. These are important parameters of disease activity and prognosis. Both disease symptoms and treatment side effects can impact patients’ quality of life.
    23 Jun 2022
    The main purpose of this amendment was to revise the inclusion/exclusion criteria to allow for facilitated recruitment in line with the study rationale.

    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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