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    Clinical Trial Results:
    A multiple-dose, subject- and investigator-blinded, placebo-controlled, parallel design study to assess the efficacy, safety, and tolerability of ACZ885 (canakinumab) in patients with pulmonary sarcoidosis

    Summary
    EudraCT number
    		 2016-001255-49
    Trial protocol
    		 DE   NL  
    Global end of trial date
    04 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2020
    First version publication date
    15 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CACZ885X2205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +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
    04 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective for this trial was to determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDG-PET in nodules (nodular uptake regions) after 12 weeks of treatment, compared to placebo.
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 2016
    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: 20
    Country: Number of subjects enrolled
    Netherlands: 14
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    40
    EEA total number of subjects
    34
    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)
    39
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Safety Analysis set : 20 patients ACZ885 and 20 patients Placebo PK Analysis set : 20 patients ACZ885 PD Analysis set : 20 patients CAZ885 and 20 patients placebo

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Roles Blinded : Subjects and Investigators

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ACZ885
    Arm description
    		 ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ACZ5885
    Investigational medicinal product code
    Other name
    canakinumab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    vials of 150mg/mL administration : Doses of 300 mg ACZ885 s.c. every four weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    vials of 150mg/mL administration : Doses of placebo to match the 300 mg ACZ885 s.c. every four weeks

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Investigator and subjects were blinded
    Number of subjects in period 1
    		ACZ885 Placebo
    Started
    20
    20
    Completed
    18
    15
    Not completed
    2
    5
         Adverse event, non-fatal
    -
    1
         Subject / Guardian decision
    1
    3
         New Therapy for study indication
    1
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    		 ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.

    Reporting group values
    		 ACZ885 Placebo Total
    Number of subjects
    		 20 20 40
    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)
    		 20 19 39
        From 65-84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ( 8.45 ) 48.1 ( 9.94 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 8 4 12
        Male
    		 12 16 28
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        Black or African American
    		 2 1 3
        White
    		 18 16 34
        Asian
    		 0 2 2
        Other
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    		 ACZ885 (300 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (0 mg/2 mL) will be administered subcutaneously to assigned study subjects once monthly for 6 months.

    Primary: Change between baseline and week 24 in pulmonary function as measured by spirometry

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    End point title
    		 Change between baseline and week 24 in pulmonary function as measured by spirometry [1]
    End point description
    To compare the effect of ACZ885 versus placebo in the change between baseline and week 24 in pulmonary function as measured by spirometry (Predicted Forced Vital Capacity).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no statistical analysis were provided
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    17
    16
    Units: Percent Predicted Forced Vital Capacity
        arithmetic mean (standard deviation)
    -1.90 ( 3.91 )
    0.52 ( 3.37 )
    No statistical analyses for this end point

    Secondary: Change between baseline and week 12 in pulmonary tissue inflammation as measured by SUVmax [F-18]FDG-PET/CT

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    End point title
    		 Change between baseline and week 12 in pulmonary tissue inflammation as measured by SUVmax [F-18]FDG-PET/CT
    End point description
    To determine the effect of ACZ885 on the change of pulmonary tissue inflammation (lung parenchyma) as measured by SUVmax [F-18]FDG-PET/CT from baseline after 12 weeks of treatment compared to placebo.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    16
    15
    Units: Percent of Change in [F-18]FDG-PET
        arithmetic mean (standard deviation)
    -4.48 ( 37.45 )
    4.07 ( 26.61 )
    No statistical analyses for this end point

    Secondary: Change between baseline and week 12 in nodular uptake regions as measured by SUVmax[F-18]FDG-PET/CT

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    End point title
    		 Change between baseline and week 12 in nodular uptake regions as measured by SUVmax[F-18]FDG-PET/CT
    End point description
    To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDG-PET in nodules (nodular uptake regions) after 12 weeks of treatment, compared to placebo.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    17
    16
    Units: percentage (Mean % Change In SUVmax)
        arithmetic mean (standard deviation)
    -7.70 ( 35.77 )
    1.03 ( 41.10 )
    No statistical analyses for this end point

    Secondary: Change between baseline and week 12 in in the extrathoracic Region as measured by SUVmax[F-18]FDG-PET/CT

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    End point title
    		 Change between baseline and week 12 in in the extrathoracic Region as measured by SUVmax[F-18]FDG-PET/CT
    End point description
    To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDG-PET in in the extrathoracic Region after 12 weeks of treatment, compared to placebo.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    4
    7
    Units: percentage (Mean % Change In SUVmax)
        arithmetic mean (standard deviation)
    -21.4 ( 13.15 )
    1.76 ( 39.60 )
    No statistical analyses for this end point

    Secondary: Change from baseline in other parameters of pulmonary function testing (FEV 1, 3, 6 seconds and predicted)

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    End point title
    		 Change from baseline in other parameters of pulmonary function testing (FEV 1, 3, 6 seconds and predicted)
    End point description
    To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Forced Expiratory Volume (FEV) in 1, 3, 6 seconds, predicted and forced expiratory flow 25-75%. Results expressed in change from baseline
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    17
    16
    Units: Liter/second
    median (full range (min-max))
        FEV in 1 Second
    -0.06 (-0.12 to 0.01)
    0.05 (-0.202 to 0.12)
        FEV in 3 seconds
    -0.08 (-0.15 to 0.01)
    0.04 (-0.04 to 0.11)
        FEV in 6 seconds
    -0.08 (-0.15 to 0.01)
    0.04 (-0.03 to 0.11)
        Predicted FEV
    -1.20 (-2.87 to 0.48)
    0.89 (-0.87 to 2.66)
        Forced Expiratory Flow 25-75%
    -0.0 (-1.0 to 0.8)
    0.1 (-0.1 to 0.6)
    No statistical analyses for this end point

    Secondary: Change from baseline in High Resolution Computed Tomography (HRCT) scoring

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    End point title
    		 Change from baseline in High Resolution Computed Tomography (HRCT) scoring
    End point description
    To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis at 24 weeks compared to initial HRCT scan as measured by side-by-side comparison by blinded reviewers and HRCT scoring.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    18
    15
    Units: score on a scale
    least squares mean (standard error)
        Parameter (unit): Mean of Consolidation
    0.11 ( 0.21 )
    0.00 ( 0.24 )
        Parameter (unit): Mean of Fibrosis
    0.14 ( 0.20 )
    -0.26 ( 0.22 )
        Parameter (unit): Mean of Ground Glass Opacities
    0.12 ( 0.39 )
    -0.21 ( 0.43 )
        Parameter (unit): Mean of Linear Opacities
    -0.08 ( 0.04 )
    -0.00 ( 0.05 )
        Parameter (unit): Mean of Nodule
    0.55 ( 0.57 )
    -0.46 ( 0.63 )
        Parameter (unit): Mean of Total Sarcoidosis Score
    0.47 ( 1.04 )
    -0.79 ( 1.14 )
    No statistical analyses for this end point

    Secondary: Change from baseline distance walked as assessed by the 6-minute walk test

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    End point title
    		 Change from baseline distance walked as assessed by the 6-minute walk test
    End point description
    To determine the effect of ACZ885 versus placebo on the 6-minute walk test distance of patients with sarcoidosis at 12 and 24 weeks compared to baseline
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, and Week 24
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    4
    4
    Units: meter
    arithmetic mean (standard deviation)
        Baseline
    453.65 ( 98.643 )
    502.36 ( 79.368 )
        Week 12
    471.57 ( 85.623 )
    510.39 ( 99.555 )
        Week 24
    479.40 ( 95.212 )
    511.74 ( 104.359 )
    No statistical analyses for this end point

    Secondary: Change from baseline of additional [F-18]FDG-PET outcomes

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    End point title
    		 Change from baseline of additional [F-18]FDG-PET outcomes
    End point description
    To determine the effect of ACZ885 on additional [F-18]FDG-PET outcomes after 12 weeks of treatment compared to placebo. SUVmean: Mean standard uptake value for activity in the focal region volume SUVpeak: Mean standardized uptake value of a sphere (a diamater of approximately 1.2cm – to produce a 1-cm3-volume spherical Region of Interest (ROI) that has the highest average SUV with the lesion volume
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    20 [2]
    20 [3]
    Units: percentage of Change In SUVmean
    least squares mean (standard error)
        SUV mean lymph nodes
    -12.1 ( 8.09 )
    -4.77 ( 8.35 )
        SUV mean lung parenchyma
    -6.39 ( 9.00 )
    -3.87 ( 9.30 )
        SUV mean extra thoracic Region
    -9.75 ( 15.23 )
    -15.2 ( 11.39 )
    Notes
    [2] - lymph nodes n =17 lung parenchyma n =16 extra thoracic Region n =4
    [3] - lymph nodes n =16 lung parenchyma n=15 extra thoracic Region n=7
    No statistical analyses for this end point

    Secondary: Change from baseline in other parameters of pulmonary function testing : Diffusion Capacity of Lung for CO

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    End point title
    		 Change from baseline in other parameters of pulmonary function testing : Diffusion Capacity of Lung for CO
    End point description
    To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, week 24
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    20
    20
    Units: mL/min/mmHg
        arithmetic mean (standard deviation)
    -0.85 ( 1.740 )
    -1.05 ( 1.978 )
    No statistical analyses for this end point

    Secondary: Change from baseline in other parameters of pulmonary function testing : Percent Predicted DLco, FEV1/FVC, FEV3/FVC, percent Predicted forced expiratory flow (FEF) 25-75, RV/TLC (Residual Volume /Total Lung Capacity)

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    End point title
    		 Change from baseline in other parameters of pulmonary function testing : Percent Predicted DLco, FEV1/FVC, FEV3/FVC, percent Predicted forced expiratory flow (FEF) 25-75, RV/TLC (Residual Volume /Total Lung Capacity)
    End point description
    To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Percent Predicted DLco (Diffusion Capacity of Lung for CO), FEV1/FVC, FEV3/FVC (forced expiratory volume in 1 or 3 seconds /forced vital capacity), percent Predicted FEF25-75, RV/TLC
    End point type
    Secondary
    End point timeframe
    Baseline, week 24
    End point values
    		 ACZ885 Placebo
    Number of subjects analysed
    20
    20
    Units: percentage
    arithmetic mean (standard deviation)
        % Predicted DLco
    -2.68 ( 5.082 )
    -2.71 ( 5.028 )
        % FEV1/FVC
    0.19 ( 3.549 )
    0.73 ( 2.221 )
        % FEV3/FVC
    -0.05 ( 2.617 )
    0.21 ( 1.612 )
        %Predicted FEF25-75
    -0.94 ( 11.375 )
    3.22 ( 5.485 )
        % RV/TLC (Residual Volume /Total Lung Capacity)
    0.63 ( 3.106 )
    0.23 ( 3.243 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    40 months
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    ACZ885 300 mg
    Reporting group description
    		 ACZ885 300 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 ACZ885 300 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 20 (20.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Atypical mycobacterium test positive
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ACZ885 300 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 20 (75.00%)
    14 / 20 (70.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    4 / 20 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    4
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 20 (30.00%)
    5 / 20 (25.00%)
         occurrences all number
    6
    6
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Dyspnoea
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Muscle spasms
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 20 (25.00%)
    6 / 20 (30.00%)
         occurrences all number
    7
    9
    Pulpitis dental
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2017
    This amendment was prepared to modify the inclusion and exclusion criteria to better recruit the relevant patient population for the study and to address operational challenges

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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