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    Clinical Trial Results:
    A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients

    Summary
    EudraCT number
    		 2017-004702-17
    Trial protocol
    		 AT   CZ   EE   LV   LT   ES   PL   BG   IT  
    Global end of trial date
    05 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Oct 2020
    First version publication date
    02 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    COMB157G2102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03560739
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Postfach, Basel, Switzerland, 4002
    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
    05 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate Pharmacokinetic (PK) bioequivalence of 20 mg ofatumumab injected by the pre-filled syringe (PFS) or autoinjector devices (AI)
    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
    11 Sep 2018
    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
    Austria: 19
    Country: Number of subjects enrolled
    Bulgaria: 20
    Country: Number of subjects enrolled
    Czech Republic: 37
    Country: Number of subjects enrolled
    Estonia: 13
    Country: Number of subjects enrolled
    Latvia: 13
    Country: Number of subjects enrolled
    Lithuania: 8
    Country: Number of subjects enrolled
    Russian Federation: 72
    Country: Number of subjects enrolled
    Spain: 37
    Country: Number of subjects enrolled
    United States: 65
    Worldwide total number of subjects
    284
    EEA total number of subjects
    147
    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)
    284
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 344 participants were screened

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OMB 20mg AI abdomen
    Arm description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen
    Arm type
    		 Experimental

    Investigational medicinal product name
    ofatumumab
    Investigational medicinal product code
    OMB157
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI) to abdomen

    Arm title
    		 OMB 20mg PFS abdomen
    Arm description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen
    Arm type
    		 Experimental

    Investigational medicinal product name
    ofatumumab
    Investigational medicinal product code
    OMB157
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ofatumumab 20 mg subcutaneous injection administered with pre-filled syringe (PFS) to abdomen

    Arm title
    		 OMB 20mg AI thigh
    Arm description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh
    Arm type
    		 Experimental

    Investigational medicinal product name
    ofatumumab
    Investigational medicinal product code
    OMB157
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI) to thigh

    Arm title
    		 OMB 20mg PFS thigh
    Arm description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh
    Arm type
    		 Experimental

    Investigational medicinal product name
    ofatumumab
    Investigational medicinal product code
    OMB157
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ofatumumab 20 mg subcutaneous injection administered with pre-filled syringe (PFS) to thigh

    Number of subjects in period 1
    		OMB 20mg AI abdomen OMB 20mg PFS abdomen OMB 20mg AI thigh OMB 20mg PFS thigh
    Started
    128
    130
    13
    13
    Completed
    128
    129
    13
    13
    Not completed
    0
    1
    0
    0
         Adverse event, non-fatal
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OMB 20mg AI abdomen
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen

    Reporting group title
    OMB 20mg PFS abdomen
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen

    Reporting group title
    OMB 20mg AI thigh
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh

    Reporting group title
    OMB 20mg PFS thigh
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh

    Reporting group values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen OMB 20mg AI thigh OMB 20mg PFS thigh Total
    Number of subjects
    		 128 130 13 13 284
    Age Categorical
    Units: participants
        18 to 30 years
    		 32 29 5 2 68
        31 to 40 years
    		 42 53 3 10 108
        41 to 55 years
    		 54 48 5 1 108
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.8 ± 9.37 37.4 ± 8.66 35.4 ± 8.75 33.2 ± 6.18 -
    Sex: Female, Male
    Units: participants
        Female
    		 92 90 9 8 199
        Male
    		 36 40 4 5 85
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 1
        Black or African American
    		 2 4 0 0 6
        White
    		 125 125 13 12 275
        Mixed
    		 0 1 0 1 2

    End points

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    End points reporting groups
    Reporting group title
    OMB 20mg AI abdomen
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on abdomen

    Reporting group title
    OMB 20mg PFS abdomen
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on abdomen

    Reporting group title
    OMB 20mg AI thigh
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with autoinjector (AI) administrated on thigh

    Reporting group title
    OMB 20mg PFS thigh
    Reporting group description
    		 Ofatumumab 20 mg subcutaneous (s.c.) injection with pre-filled syringes (PFS) administrated on thigh

    Primary: Bioequivalence of 20 mg ofatumumab injected by pre-filled syringe (PFS) vs autoinjector (AI) to abdomen as measured by AUCtau

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    End point title
    		 Bioequivalence of 20 mg ofatumumab injected by pre-filled syringe (PFS) vs autoinjector (AI) to abdomen as measured by AUCtau [1]
    End point description
    Bioequivalence of AUCtau ) will be measured over the time period 8 to 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
    End point type
    Primary
    End point timeframe
    Week 8 to Week 12 dosing interval
    Notes
    [1] - 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: Bioequivalence was analyzed for abdomen arms only
    End point values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen
    Number of subjects analysed
    128
    128
    Units: h×µg/mL
        geometric mean (geometric coefficient of variation)
    487.7 ± 103.5
    474.1 ± 79.7
    Statistical analysis title
    		 Criteria 1 for bioequivalence testing of AUCtau
    Statistical analysis description
    For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 1.
    Comparison groups
    OMB 20mg AI abdomen v OMB 20mg PFS abdomen
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Geo-mean ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.25
    Notes
    [2] - The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.
    Statistical analysis title
    		 Criteria 2 for bioequivalence testing of AUCtau
    Statistical analysis description
    For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 2.
    Comparison groups
    OMB 20mg AI abdomen v OMB 20mg PFS abdomen
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 95% upper bound of the linearized criter
    Point estimate
    -0.3131
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0
    Notes
    [3] - The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion

    Primary: Bioequivalence of 20 mg ofatumumab injected by pre-filled syringe (PFS) vs autoinjector (AI) to abdomen as measured by Cmax

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    End point title
    		 Bioequivalence of 20 mg ofatumumab injected by pre-filled syringe (PFS) vs autoinjector (AI) to abdomen as measured by Cmax [4]
    End point description
    Bioequivalence of Cmax will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
    End point type
    Primary
    End point timeframe
    Week 8 to Week 12 dosing interval
    Notes
    [4] - 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: Bioequivalence was analyzed for abdomen arms only
    End point values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen
    Number of subjects analysed
    128
    128
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    1.409 ± 89.2
    1.409 ± 67.9
    Statistical analysis title
    		 Criteria 1 for bioequivalence testing of of Cmax
    Statistical analysis description
    For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 1.
    Comparison groups
    OMB 20mg AI abdomen v OMB 20mg PFS abdomen
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 geo-mean ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.25
    Notes
    [5] - The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.
    Statistical analysis title
    		 Criteria 2 for bioequivalence testing of Cmax
    Statistical analysis description
    For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in [0.8, 1.25]; 2) 95% upper bound of the linearized criterion needs to be <= 0. This part is regarding criterion 2.
    Comparison groups
    OMB 20mg AI abdomen v OMB 20mg PFS abdomen
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 95% upper bound of the linearized criter
    Point estimate
    -0.2446
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0
    Notes
    [6] - The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion

    Secondary: Pharmacokinetics of the study drug as measured by AUCtau for PFS and AI devices when administered to abdomen or thigh

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    End point title
    		 Pharmacokinetics of the study drug as measured by AUCtau for PFS and AI devices when administered to abdomen or thigh
    End point description
    Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the area under the concentration-time curve over the Week 8 to Week 12 dosing interval (AUCtau)
    End point type
    Secondary
    End point timeframe
    Week 8 to Week 12 dosing interval
    End point values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen OMB 20mg AI thigh OMB 20mg PFS thigh
    Number of subjects analysed
    128
    128
    13
    13
    Units: h×µg/mL
        geometric mean (geometric coefficient of variation)
    487.7 ± 103.5
    474.1 ± 79.7
    476.0 ± 73.1
    544.1 ± 93.8
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of the study drug as measured by Cmax for PFS and AI devices when administered to abdomen or thigh

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    End point title
    		 Pharmacokinetics of the study drug as measured by Cmax for PFS and AI devices when administered to abdomen or thigh
    End point description
    Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the maximum concentration (Cmax)
    End point type
    Secondary
    End point timeframe
    Week 8 to Week 12 dosing interval
    End point values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen OMB 20mg AI thigh OMB 20mg PFS thigh
    Number of subjects analysed
    128
    128
    13
    13
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    1.409 ± 89.2
    1.409 ± 67.9
    1.563 ± 71.3
    1.635 ± 50.7
    No statistical analyses for this end point

    Secondary: Plasma concentrations for PFS and AI devices when administered to abdomen or thigh

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    End point title
    		 Plasma concentrations for PFS and AI devices when administered to abdomen or thigh
    End point description
    Plasma concentrations following subcutaneous administration of ofatumumab via PFS or AI to either the abdominal region or the thigh
    End point type
    Secondary
    End point timeframe
    Days 1, 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84
    End point values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen OMB 20mg AI thigh OMB 20mg PFS thigh
    Number of subjects analysed
    128
    130
    13
    13
    Units: μg/mL
    geometric mean (geometric coefficient of variation)
        Day 4 n=128,127,13,13
    0.43076 ± 147.591319
    0.40075 ± 119.330376
    0.86747 ± 24.481350
    0.55704 ± 105.432315
        Day 7 n=128, 130,13,13
    0.33544 ± 133.205087
    0.30511 ± 119.511321
    0.36750 ± 94.007762
    0.29662 ± 119.353006
        Day 14 n=128, 130,12,11
    1.07408 ± 105.566707
    0.96359 ± 105.735963
    0.89788 ± 125.726458
    1.30586 ± 83.153962
        Day 28 Week 4 n=127, 130,13,13
    0.95571 ± 113.510035
    0.95774 ± 117.852822
    1.11008 ± 66.780045
    1.41434 ± 117.959678
        Day 42 Week 6 n=128, 130,13,13
    0.97327 ± 125.421064
    1.12006 ± 113.137164
    1.12006 ± 86.390639
    1.18239 ± 133.082660
        Day 56 Week 8 n=128, 130,13,13
    0.28358 ± 142.760137
    0.24644 ± 133.056913
    0.23874 ± 98.041287
    0.45529 ± 143.614763
        Day 57 Week 8 n=127, 127,12,13
    0.89424 ± 121.357310
    0.80986 ± 107.929658
    0.96356 ± 122.222991
    1.04905 ± 54.771002
        Day 59 Week 8 n=127, 127,13,13
    1.24143 ± 103.274314
    1.23458 ± 81.737063
    1.34837 ± 82.596695
    1.52705 ± 52.253239
        Day 63 Week 9 n=126, 128,13,13
    1.27031 ± 84.610014
    1.23163 ± 77.294222
    1.28263 ± 67.076249
    1.43075 ± 66.345270
        Day 70 Week 10 n=128, 127,13,13
    0.78732 ± 97.440131
    0.74111 ± 82.870974
    0.67151 ± 82.769087
    0.95821 ± 83.645358
        Day 77 Week 11 n=127, 127,13,13
    0.40249 ± 109.581877
    0.33720 ± 114.373887
    0.40173 ± 52.479338
    0.54085 ± 97.862609
        EOS Week 12 n=126, 118,12,13
    0.20290 ± 113.812416
    0.17862 ± 102.507484
    0.17361 ± 63.899086
    0.27276 ± 98.256573
    No statistical analyses for this end point

    Secondary: Percentage of patients with anti-ofatumumab antibodies

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    End point title
    		 Percentage of patients with anti-ofatumumab antibodies
    End point description
    Anti-drug antibodies (ADA) were assessed to evaluate the immunogenicity potential of ofatumumab. Samples for ADA assessment were taken prior to dosing at the visit. Samples were analyzed as per laboratory’s SOPs by a Meso Scale Discovery (MSD) electrochemiluminescense assay. All samples confirmed to be positive for the presence of anti-ofatumumab antibodies were assessed to evaluate their ability to neutralize the ofatumumab biologic effect.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12 and Overall
    End point values
    		 OMB 20mg AI abdomen OMB 20mg PFS abdomen OMB 20mg AI thigh OMB 20mg PFS thigh
    Number of subjects analysed
    128
    130
    13
    13
    Units: percentage of participants
    number (not applicable)
        Baseline n= 128,130,13,13
    0.8
    3.1
    0.0
    7.7
        Week 4 n= 128,130,13,13
    0.8
    0.0
    0.0
    0.0
        Week 8 n= 124,126,13,13
    0.0
    0.8
    0.0
    0.0
        Week 12 n= 125,121, 12,13
    0.8
    0.0
    0.0
    0.0
        Overall n= 128,130,13,13
    0.8
    3.8
    0.0
    7.7
    No statistical analyses for this end point

    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 last administration of study treatment plus 100 days post treatment, up to maximum duration of 226 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    OMB 20mg AI (ABD)
    Reporting group description
    		 OMB 20mg AI (ABD)

    Reporting group title
    OMB 20mg PFS (ABD)
    Reporting group description
    		 OMB 20mg PFS (ABD)

    Reporting group title
    OMB 20mg AI (THI)
    Reporting group description
    		 OMB 20mg AI (THI)

    Reporting group title
    OMB 20mg PFS (THI)
    Reporting group description
    		 OMB 20mg PFS (THI)

    Serious adverse events
    		 OMB 20mg AI (ABD) OMB 20mg PFS (ABD) OMB 20mg AI (THI) OMB 20mg PFS (THI)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 128 (1.56%)
    4 / 130 (3.08%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    0 / 13 (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
    Gastrointestinal disorders
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    0 / 13 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    0 / 13 (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
    Pneumonia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    0 / 13 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OMB 20mg AI (ABD) OMB 20mg PFS (ABD) OMB 20mg AI (THI) OMB 20mg PFS (THI)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 128 (47.66%)
    53 / 130 (40.77%)
    7 / 13 (53.85%)
    7 / 13 (53.85%)
    Injury, poisoning and procedural complications
    Injection related reaction
         subjects affected / exposed
    41 / 128 (32.03%)
    29 / 130 (22.31%)
    5 / 13 (38.46%)
    6 / 13 (46.15%)
         occurrences all number
    52
    39
    8
    11
    Ligament sprain
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 130 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Head discomfort
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 130 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    13 / 128 (10.16%)
    7 / 130 (5.38%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    29
    14
    0
    1
    Neuralgia
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 130 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    3 / 128 (2.34%)
    0 / 130 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    1 / 128 (0.78%)
    2 / 130 (1.54%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 128 (1.56%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    0
    1
    Fatigue
         subjects affected / exposed
    3 / 128 (2.34%)
    5 / 130 (3.85%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    4
    5
    2
    0
    Injection site pain
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Injection site reaction
         subjects affected / exposed
    11 / 128 (8.59%)
    17 / 130 (13.08%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    15
    34
    0
    1
    Pain
         subjects affected / exposed
    1 / 128 (0.78%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 128 (4.69%)
    4 / 130 (3.08%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    6
    4
    1
    0
    Nausea
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 128 (0.78%)
    2 / 130 (1.54%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 128 (1.56%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 128 (0.00%)
    3 / 130 (2.31%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    2 / 128 (1.56%)
    1 / 130 (0.77%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle contracture
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Spinal pain
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 130 (0.77%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Tendonitis
         subjects affected / exposed
    2 / 128 (1.56%)
    0 / 130 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 130 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 128 (0.78%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 128 (1.56%)
    5 / 130 (3.85%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    5
    0
    1
    Oral herpes
         subjects affected / exposed
    2 / 128 (1.56%)
    1 / 130 (0.77%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    3 / 128 (2.34%)
    3 / 130 (2.31%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    3
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 130 (0.77%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 128 (0.78%)
    2 / 130 (1.54%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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