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    Clinical Trial Results:
    A PHASE 2 MULTI-CENTER, RANDOMIZED, DOUBLE-MASKED, PLACEBO CONTROLLED, MULTI-DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RN6G (PF 04382923) IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION

    Summary
    EudraCT number
    2012-000823-42
    Trial protocol
    DE   GB   IT  
    Global end of trial date
    10 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    12 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1181003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01577381
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    US IND Number : 102691
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc, +1 8007181021, ClinicalTrials.govCallCenter@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, +1 8007181021, ClinicalTrials.govCallCenter@pfizer.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
    15 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the efficacy of RN6G (PF-04382923) in subjects with geographic atrophy in the study eye.
    Protection of trial subjects
    This study used an External Data Monitoring Committee (E-DMC). The E-DMC (consisted of physicians, ophthalmologists, safety specialists and statisticians) was responsible for ongoing safety monitoring of subjects in the study and may review efficacy in the context of risk-benefit assessment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Jun 2012
    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
    United States: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    0
    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)
    2
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted in the United States of America (USA). Eligible subjects were men and women (of non-childbearing potential) between the ages of 60 and 90 years with a diagnosis of a well-demarcated area of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

    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
    PF-04382923 2.5 mg/kg
    Arm description
    PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-04382923
    Investigational medicinal product code
    Other name
    RN6G
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV infusion over at least 30 minutes every 28 days for 11 doses.

    Arm title
    PF-04382923 7.5 mg/kg
    Arm description
    PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-04382923
    Investigational medicinal product code
    Other name
    RN6G
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV infusion over at least 30 minutes every 28 days for 11 doses.

    Arm title
    PF-04382923 15.0 mg/kg
    Arm description
    PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-04382923
    Investigational medicinal product code
    Other name
    RN6G
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV infusion over at least 30 minutes every 28 days for 11 doses.

    Arm title
    Placebo
    Arm description
    Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV infusion over at least 30 minutes every 28 days for 11 doses.

    Number of subjects in period 1
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Started
    2
    3
    3
    2
    Completed
    0
    0
    0
    0
    Not completed
    2
    3
    3
    2
         Consent withdrawn by subject
    2
    1
    2
    2
         Ongoing at Date of Cut-Off
    -
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-04382923 2.5 mg/kg
    Reporting group description
    PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    PF-04382923 7.5 mg/kg
    Reporting group description
    PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    PF-04382923 15.0 mg/kg
    Reporting group description
    PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.

    Reporting group values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo Total
    Number of subjects
    2 3 3 2 10
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    0 1 1 0 2
        From 65-84 years
    2 2 2 2 8
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    82.5 ± 0.7 71 ± 6.2 74 ± 12.2 73 ± 11.3 -
    Gender categorical
    Units: Subjects
        Female
    1 3 3 0 7
        Male
    1 0 0 2 3

    End points

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    End points reporting groups
    Reporting group title
    PF-04382923 2.5 mg/kg
    Reporting group description
    PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    PF-04382923 7.5 mg/kg
    Reporting group description
    PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    PF-04382923 15.0 mg/kg
    Reporting group description
    PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.

    Primary: Mean Reduction (in Study Eye) in Rate of Geographic Atrophy (GA) at Day 309

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    End point title
    Mean Reduction (in Study Eye) in Rate of Geographic Atrophy (GA) at Day 309 [1]
    End point description
    GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).
    End point type
    Primary
    End point timeframe
    Baseline and Day 309
    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: Analysis of GA reduction was not performed due to early study termination.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: square millimeter per month (mm^2/month)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [2] - Analysis of GA reduction was not performed due to early study termination.
    [3] - Analysis of GA reduction was not performed due to early study termination.
    [4] - Analysis of GA reduction was not performed due to early study termination.
    [5] - Analysis of GA reduction was not performed due to early study termination.
    No statistical analyses for this end point

    Primary: Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)

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    End point title
    Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study) [6]
    End point description
    GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).
    End point type
    Primary
    End point timeframe
    Baseline and Day 449
    Notes
    [6] - 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: Analysis of GA reduction was not performed due to early study termination.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    Units: mm^ 2 / mo n t h
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [7] - Analysis of GA reduction was not performed due to early study termination.
    [8] - Analysis of GA reduction was not performed due to early study termination.
    [9] - Analysis of GA reduction was not performed due to early study termination.
    [10] - Analysis of GA reduction was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study

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    End point title
    Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study
    End point description
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    Units: correct letters read
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [11] - Analysis of BCVA was not performed due to early study termination.
    [12] - Analysis of BCVA was not performed due to early study termination.
    [13] - Analysis of BCVA was not performed due to early study termination.
    [14] - Analysis of BCVA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
    End point description
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [15] - Analysis of BCVA was not performed due to early study termination.
    [16] - Analysis of BCVA was not performed due to early study termination.
    [17] - Analysis of BCVA was not performed due to early study termination.
    [18] - Analysis of BCVA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study
    End point description
    BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [19] - Analysis of BCVA was not performed due to early study termination.
    [20] - Analysis of BCVA was not performed due to early study termination.
    [21] - Analysis of BCVA was not performed due to early study termination.
    [22] - Analysis of BCVA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study

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    End point title
    Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study
    End point description
    LL-BCVA is the measure of visual acuity under low light conditions.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    Units: correct letters read
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [23] - Analysis of LL-BCVA was not performed due to early study termination.
    [24] - Analysis of LL-BCVA was not performed due to early study termination.
    [25] - Analysis of LL-BCVA was not performed due to early study termination.
    [26] - Analysis of LL-BCVA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study
    End point description
    LL-BCVA is the measure of visual acuity under low light conditions.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [27] - Analysis of LL-BCVA was not performed due to early study termination.
    [28] - Analysis of LL-BCVA was not performed due to early study termination.
    [29] - Analysis of LL-BCVA was not performed due to early study termination.
    [30] - Analysis of LL-BCVA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study
    End point description
    LL-BCVA is the measure of visual acuity under low light conditions.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [31] - Analysis of LL-BCVA was not performed due to early study termination.
    [32] - Analysis of LL-BCVA was not performed due to early study termination.
    [33] - Analysis of LL-BCVA was not performed due to early study termination.
    [34] - Analysis of LL-BCVA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study

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    End point title
    Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
    End point description
    Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    Units: Logmar units
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [35] - Analysis of contrast sensitivity was not performed due to early study termination.
    [36] - Analysis of contrast sensitivity was not performed due to early study termination.
    [37] - Analysis of contrast sensitivity was not performed due to early study termination.
    [38] - Analysis of contrast sensitivity was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study
    End point description
    Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [39] - Analysis of contrast sensitivity was not performed due to early study termination.
    [40] - Analysis of contrast sensitivity was not performed due to early study termination.
    [41] - Analysis of contrast sensitivity was not performed due to early study termination.
    [42] - Analysis of contrast sensitivity was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study

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    End point title
    Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
    End point description
    Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    Units: correct words read per minute
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [43] - Analysis of reading speed was not performed due to early study termination.
    [44] - Analysis of reading speed was not performed due to early study termination.
    [45] - Analysis of reading speed was not performed due to early study termination.
    [46] - Analysis of reading speed was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study

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    End point title
    Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study
    End point description
    Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [47]
    0 [48]
    0 [49]
    0 [50]
    Units: correct words read per minute
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [47] - Analysis of reading speed was not performed due to early study termination.
    [48] - Analysis of reading speed was not performed due to early study termination.
    [49] - Analysis of reading speed was not performed due to early study termination.
    [50] - Analysis of reading speed was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study
    End point description
    Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [51]
    0 [52]
    0 [53]
    0 [54]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [51] - Analysis of reading speed was not performed due to early study termination.
    [52] - Analysis of reading speed was not performed due to early study termination.
    [53] - Analysis of reading speed was not performed due to early study termination.
    [54] - Analysis of reading speed was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study

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    End point title
    Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
    End point description
    Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logarithmic Reading Acuity Determination).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [55]
    0 [56]
    0 [57]
    0 [58]
    Units: LogRAD
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [55] - Analysis of reading acuity was not performed due to early study termination.
    [56] - Analysis of reading acuity was not performed due to early study termination.
    [57] - Analysis of reading acuity was not performed due to early study termination.
    [58] - Analysis of reading acuity was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study

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    End point title
    Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study
    End point description
    Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [59]
    0 [60]
    0 [61]
    0 [62]
    Units: logRAD
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [59] - Analysis of reading acuity was not performed due to early study termination.
    [60] - Analysis of reading acuity was not performed due to early study termination.
    [61] - Analysis of reading acuity was not performed due to early study termination.
    [62] - Analysis of reading acuity was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study

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    End point title
    Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study
    End point description
    Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [63]
    0 [64]
    0 [65]
    0 [66]
    Units: percent change
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [63] - Analysis of reading acuity was not performed due to early study termination.
    [64] - Analysis of reading acuity was not performed due to early study termination.
    [65] - Analysis of reading acuity was not performed due to early study termination.
    [66] - Analysis of reading acuity was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study

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    End point title
    Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study
    End point description
    The critical print size is the smallest print size at which participants can read with their maximum reading speed.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [67]
    0 [68]
    0 [69]
    0 [70]
    Units: print size
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [67] - Analysis of critical print size reading was not performed due to early study termination.
    [68] - Analysis of critical print size reading was not performed due to early study termination.
    [69] - Analysis of critical print size reading was not performed due to early study termination.
    [70] - Analysis of critical print size reading was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study

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    End point title
    Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study
    End point description
    The critical print size is the smallest print size at which participants can read with their maximum reading speed.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 9, Month 12, Month 15, and End of Study
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [71]
    0 [72]
    0 [73]
    0 [74]
    Units: print size
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [71] - Analysis of critical print size reading was not performed due to early study termination.
    [72] - Analysis of critical print size reading was not performed due to early study termination.
    [73] - Analysis of critical print size reading was not performed due to early study termination.
    [74] - Analysis of critical print size reading was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Laboratory Abnormalities

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    End point title
    Number of Participants with Treatment-Emergent Laboratory Abnormalities
    End point description
    Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); coagulation assessments.
    End point type
    Secondary
    End point timeframe
    Day 85 and Day 169
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    Units: participants
    Notes
    [75] - Analysis of laboratory abnormalities was not performed due to early study termination.
    [76] - Analysis of laboratory abnormalities was not performed due to early study termination.
    [77] - Analysis of laboratory abnormalities was not performed due to early study termination.
    [78] - Analysis of laboratory abnormalities was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Change From Baseline in Vital Signs

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    End point title
    Number of Participants with Abnormal Change From Baseline in Vital Signs
    End point description
    Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.
    End point type
    Secondary
    End point timeframe
    Screening, Days 28, 57, 85, 113, 141, and 169
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [79]
    0 [80]
    0 [81]
    0 [82]
    Units: participants
    Notes
    [79] - Analysis of vital signs was not performed due to early study termination.
    [80] - Analysis of vital signs was not performed due to early study termination.
    [81] - Analysis of vital signs was not performed due to early study termination.
    [82] - Analysis of vital signs was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Participants with Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings

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    End point title
    Number of Participants with Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
    End point description
    Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.
    End point type
    Secondary
    End point timeframe
    Days 28, 57, 85, 113 and 169
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [83]
    0 [84]
    0 [85]
    0 [86]
    Units: participants
    Notes
    [83] - Analysis of ECG parameters was not performed due to early study termination.
    [84] - Analysis of ECG parameters was not performed due to early study termination.
    [85] - Analysis of ECG parameters was not performed due to early study termination.
    [86] - Analysis of ECG parameters was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Participants with Positive Anti-Drug Antibody (ADA)

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    End point title
    Number of Participants with Positive Anti-Drug Antibody (ADA)
    End point description
    The number of participants with positive ADA was to be summarized for each treatment arm.
    End point type
    Secondary
    End point timeframe
    Day 57 and Day 169
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [87]
    0 [88]
    0 [89]
    0 [90]
    Units: participants
    Notes
    [87] - Analysis of ADA was not performed due to early study termination.
    [88] - Analysis of ADA was not performed due to early study termination.
    [89] - Analysis of ADA was not performed due to early study termination.
    [90] - Analysis of ADA was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) According to Seriousness

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    End point title
    Number of Participants with Treatment-Emergent Adverse Events (TEAEs) According to Seriousness
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Secondary
    End point timeframe
    Days 28, 57, 85, 113, 141 and 169
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    2
    3
    3
    2
    Units: participants
        AE
    2
    0
    1
    1
        SAE
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Related TEAEs

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    End point title
    Number of Participants with Treatment-Related TEAEs
    End point description
    An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.
    End point type
    Secondary
    End point timeframe
    Days 28, 57, 85, 113, 141 and 169
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    2
    3
    3
    2
    Units: participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    Maximum Observed Plasma Concentration (Cmax) [91]
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1, 28, 57, 85, 169, 253, 281, 309, 337, and 449
    Notes
    [91] - 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: PK parameters were not planned for the placebo group.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
    Number of subjects analysed
    0 [92]
    0 [93]
    0 [94]
    Units: nanogram per milliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    Notes
    [92] - Analysis of Cmax was not performed due to early study termination.
    [93] - Analysis of Cmax was not performed due to early study termination.
    [94] - Analysis of Cmax was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Minimum Observed Plasma Trough Concentration (Cmin)

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    End point title
    Minimum Observed Plasma Trough Concentration (Cmin) [95]
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1, 28, 57, 85, 169, 253, 281, 309, 337, and 449
    Notes
    [95] - 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: PK parameters were not planned for the placebo group.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
    Number of subjects analysed
    0 [96]
    0 [97]
    0 [98]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ±
    ±
    ±
    Notes
    [96] - Analysis of Cmin was not performed due to early study termination.
    [97] - Analysis of Cmin was not performed due to early study termination.
    [98] - Analysis of Cmin was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)

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    End point title
    Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt) [99]
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1, 28, 57, 85, 169, 253, 281, 309, 337, and 449
    Notes
    [99] - 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: PK parameters were not planned for the placebo group.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
    Number of subjects analysed
    0 [100]
    0 [101]
    0 [102]
    Units: nanogram*hour per milliliter (ng*hr/mL)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [100] - Analysis of AUCt was not performed due to early study termination.
    [101] - Analysis of AUCt was not performed due to early study termination.
    [102] - Analysis of AUCt was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Clearance at Steady State (CLss)

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    End point title
    Clearance at Steady State (CLss) [103]
    End point description
    Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css).
    End point type
    Secondary
    End point timeframe
    Days 1, 28, 57, 85, 169, 253, 281, 309, 337, and 449
    Notes
    [103] - 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: PK parameters were not planned for the placebo group.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
    Number of subjects analysed
    0 [104]
    0 [105]
    0 [106]
    Units: liters per hour (L/hr)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [104] - Analysis of CLss was not performed due to early study termination.
    [105] - Analysis of CLss was not performed due to early study termination.
    [106] - Analysis of CLss was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Accumulation Ratio (Rac) for AUCt

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    End point title
    Accumulation Ratio (Rac) for AUCt [107]
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1, 28, 57, 85, 169, 253, 281, 309, 337, and 449
    Notes
    [107] - 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: PK parameters were not planned for the placebo group.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
    Number of subjects analysed
    0 [108]
    0 [109]
    0 [110]
    Units: ratio
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [108] - Analysis of Rac for AUCt was not performed due to early study termination.
    [109] - Analysis of Rac for AUCt was not performed due to early study termination.
    [110] - Analysis of Rac for AUCt was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Plasma Population PK Parameters

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    End point title
    Plasma Population PK Parameters [111]
    End point description
    Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.
    End point type
    Secondary
    End point timeframe
    Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449
    Notes
    [111] - 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: PK parameters were not planned for the placebo group.
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg
    Number of subjects analysed
    0 [112]
    0 [113]
    0 [114]
    Units: population PK analysis
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [112] - Analysis of population PK parameters was not performed due to early study termination.
    [113] - Analysis of population PK parameters was not performed due to early study termination.
    [114] - Analysis of population PK parameters was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)

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    End point title
    Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)
    End point description
    Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 449
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [115]
    0 [116]
    0 [117]
    0 [118]
    Units: picogram per milliliter (pg/mL)
        least squares mean (standard error)
    ±
    ±
    ±
    ±
    Notes
    [115] - Analysis of A-Beta 1-x was not performed due to early study termination.
    [116] - Analysis of A-Beta 1-x was not performed due to early study termination.
    [117] - Analysis of A-Beta 1-x was not performed due to early study termination.
    [118] - Analysis of A-Beta 1-x was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)

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    End point title
    Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)
    End point description
    Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 449
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [119]
    0 [120]
    0 [121]
    0 [122]
    Units: pg/mL
        least squares mean (standard error)
    ±
    ±
    ±
    ±
    Notes
    [119] - Analysis of A-Beta 1-40 was not performed due to early study termination.
    [120] - Analysis of A-Beta 1-40 was not performed due to early study termination.
    [121] - Analysis of A-Beta 1-40 was not performed due to early study termination.
    [122] - Analysis of A-Beta 1-40 was not performed due to early study termination.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)

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    End point title
    Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)
    End point description
    Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 449
    End point values
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Number of subjects analysed
    0 [123]
    0 [124]
    0 [125]
    0 [126]
    Units: pg/mL
        least squares mean (standard error)
    ±
    ±
    ±
    ±
    Notes
    [123] - Analysis of A-Beta 1-42 was not performed due to early study termination.
    [124] - Analysis of A-Beta 1-42 was not performed due to early study termination.
    [125] - Analysis of A-Beta 1-42 was not performed due to early study termination.
    [126] - Analysis of A-Beta 1-42 was not performed due to early study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Days 28, 57, 85, 113, 141, and 169 (or early termination)
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    PF-04382923 2.5 mg/kg
    Reporting group description
    PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    PF-04382923 7.5 mg/kg
    Reporting group description
    PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    PF-04382923 15.0 mg/kg
    Reporting group description
    PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.

    Serious adverse events
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    PF-04382923 2.5 mg/kg PF-04382923 7.5 mg/kg PF-04382923 15.0 mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Nephropathy
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Tendonitis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0

    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.
    The study was terminated early due to an organizational decision, which was not based on safety or efficacy concerns. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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