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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA)

    Summary
    EudraCT number
    		 2015-003140-39
    Trial protocol
    		 BG   PL  
    Global end of trial date
    25 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2019
    First version publication date
    04 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AE051-G-13-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Akros Pharma Inc.
    Sponsor organisation address
    302 Carnegie Center, Suite 300, Princeton, United States, NJ 08540
    Public contact
    Kala Patel, Akros Pharma Inc., patel@akrospharma.com
    Scientific contact
    Kala Patel, Akros Pharma Inc., patel@akrospharma.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
    18 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate the clinical efficacy of JTE-051 in subjects with active rheumatoid arthritis receiving background non-biologic disease-modifying anti-rheumatic drug therapy - To evaluate the safety and tolerability of JTE-051 administered for 12 weeks to subjects with active rheumatoid arthritis receiving background non-biologic disease-modifying anti-rheumatic drug therapy - To evaluate the pharmacokinetics of JTE-051 in plasma of subjects with active rheumatoid arthritis
    Protection of trial subjects
    This study was conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s) (e.g., 21 CFR Part 50, 56, 312 in the US), Sponsor’s and/or Contract Research Organization (CRO) policies and procedures and all clinical trial regulations. The ICF and other written information provided to subjects were to be revised whenever important new information that may have been relevant to the subject’s consent became available. The revised ICF and other written information were to be approved by the IRB/IEC in advance of use. The subjects were to be informed in a timely manner when new information became available that may have been relevant to their willingness to continue participation in the study. The communication of this information was to be documented. The Investigator, or a person designated by the Investigator, fully informed the subject of all pertinent aspects of the study, including the written information and approval by the IRB/IEC.
    Background therapy
    		 Background treatment with up to two non-biologic DMARDs including methotrexate and one of the following medications (optional): sulfasalazine ≤3 g/day, hydroxychloroquine ≤400 mg/day or chloroquine: ≤250 mg/day, at the time of the Screening Visit. Subjects were to receive up to two non-biologic DMARDs, including methotrexate, at a stable dose and route of administration for at least 12 weeks prior to Visit 2 (Randomization visit) and continue receiving background treatment of up to two non-biologic DMARDs at a stable dose during the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Sep 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
    Poland: 5
    Country: Number of subjects enrolled
    Bulgaria: 25
    Country: Number of subjects enrolled
    Argentina: 20
    Country: Number of subjects enrolled
    Mexico: 67
    Country: Number of subjects enrolled
    Peru: 46
    Country: Number of subjects enrolled
    Romania: 8
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    Ukraine: 69
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    259
    EEA total number of subjects
    38
    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)
    225
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.

    Pre-assignment
    Screening details
    		 Following signature of the informed consent for the study, screening procedures (up to a 28-day Screening Period) to confirm eligibility were performed across multiple days, as needed, during the Screening Period. A total of 528 subjects were screened, 268 subjects were screen failures and 259 subjects were included in the randomized population.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This study was double-blind (i.e., the treatment assigned to each subject was not disclosed to the Sponsor members or designees involved in the study, study staff at the site or to the subject). The JTE-051 50 mg tablets, as well as the placebo tablets were supplied as unbranded tablets which are identical in appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JTE-051 50 mg
    Arm description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTE-051 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects receive JTE-051 50 mg QD.

    Arm title
    		 JTE-051 100 mg
    Arm description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTE-051 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects receive JTE-051 100 mg QD.

    Arm title
    		 JTE-051 150 mg
    Arm description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 Placebo) taken in the morning from the blister card.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTE-051 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects receive JTE-051 150 mg QD.

    Arm title
    		 JTE-051 200 mg
    Arm description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 50 mg) taken in the morning from the blister card.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JTE-051 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects receive JTE-051 200 mg QD.

    Arm title
    		 Placebo
    Arm description
    		 Each dose consisted of 4 tablets (JTE-051 Placebo, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo ) taken in the morning from the blister card.
    Arm type
    		 Placebo

    Investigational medicinal product name
    JTE-051 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The subjects receive Placebo QD.

    Number of subjects in period 1 [1]
    		JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg Placebo
    Started
    51
    51
    52
    51
    52
    Completed
    45
    43
    47
    38
    48
    Not completed
    6
    8
    5
    13
    4
         Consent withdrawn by subject
    2
    3
    1
    2
    2
         Inclusion/exclusion criteria not met
    1
    1
    1
    1
    -
         Adverse event, non-fatal
    3
    3
    3
    9
    2
         Death
    -
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 259 patients were enrolled in the study, 257 patients were included in the Intent-to-treat population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JTE-051 50 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 100 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 150 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 200 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 50 mg) taken in the morning from the blister card.

    Reporting group title
    Placebo
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 Placebo, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo ) taken in the morning from the blister card.

    Reporting group values
    		 JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg Placebo Total
    Number of subjects
    		 51 51 52 51 52 257
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 42 48 46 43 44 223
        From 65-84 years
    		 9 3 6 8 8 34
    Age continuous
    Units: years
        median (full range (min-max))
    		 52 (23 to 74) 53 (30 to 69) 48 (26 to 72) 51 (26 to 72) 53 (24 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 41 40 44 43 43 211
        Male
    		 10 11 8 8 9 46
    Subject analysis sets

    Subject analysis set title
    Randomized subjects (RAND)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    RAND includes all randomized subjects.

    Subject analysis set title
    Safety population (SAFE)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.

    Subject analysis set title
    PK Population (PK)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK population includes all randomized subjects who received at least one dose of study drug and have at least one usable JTE-051 plasma concentration measurement.

    Subject analysis set title
    Intent-to-Treat Population (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat population (ITT) includes all randomized subjects who received at least one dose of study drug and have at least one post-baseline efficacy assessments during the double-blind Treatment Period.

    Subject analysis set title
    Per Protocol (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) is a subset of the ITT population in which subjects did not have any major protocol deviations and met overall 80% to 120% compliance.

    Subject analysis set title
    JTE-051 analysis set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    JTE-051 analysis set includes all subjects which have been treated with JTE-051.

    Subject analysis sets values
    		 Randomized subjects (RAND) Safety population (SAFE) PK Population (PK) Intent-to-Treat Population (ITT) Per Protocol (PP) JTE-051 analysis set
    Number of subjects
    259
    258
    183
    257
    206
    206
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    225
    223
        From 65-84 years
    34
    34
    Age continuous
    Units: years
        median (full range (min-max))
    52 (23 to 75)
    52 (23 to 75)
    52 (23 to 75)
    51.5 (23 to 73)
    Gender categorical
    Units: Subjects
        Female
    212
    211
    211
    168
        Male
    47
    47
    46
    38

    End points

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    End points reporting groups
    Reporting group title
    JTE-051 50 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 100 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 150 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 200 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 50 mg) taken in the morning from the blister card.

    Reporting group title
    Placebo
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 Placebo, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo ) taken in the morning from the blister card.

    Subject analysis set title
    Randomized subjects (RAND)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    RAND includes all randomized subjects.

    Subject analysis set title
    Safety population (SAFE)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.

    Subject analysis set title
    PK Population (PK)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK population includes all randomized subjects who received at least one dose of study drug and have at least one usable JTE-051 plasma concentration measurement.

    Subject analysis set title
    Intent-to-Treat Population (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat population (ITT) includes all randomized subjects who received at least one dose of study drug and have at least one post-baseline efficacy assessments during the double-blind Treatment Period.

    Subject analysis set title
    Per Protocol (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol (PP) is a subset of the ITT population in which subjects did not have any major protocol deviations and met overall 80% to 120% compliance.

    Subject analysis set title
    JTE-051 analysis set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    JTE-051 analysis set includes all subjects which have been treated with JTE-051.

    Primary: ACR20 Response Rate at EOT

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    End point title
    		 ACR20 Response Rate at EOT [1] [2]
    End point description
    ACR20 = Percentage of subjects achieving at least 20% improvement from baseline in tender and swollen joint counts and at least 20% improvement in the three of the five remaining American College of Rheumatology core set measures.
    End point type
    Primary
    End point timeframe
    The primary efficacy endpoint was the ACR20 response rate at End of Treatment.
    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: Statistical Analysis was performed using the Fisher's exact test at the two-sided 5% significance level. Result: No statistically significant differences in ACR20 response rate were noted between the placebo group and any of JTE-051 dose group.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ACR20 Response Rate at EOT has been compared for each treatment arm with Placebo.
    End point values
    		 JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg
    Number of subjects analysed
    51
    51
    52
    51
    Units: Percent
    number (confidence interval 95%)
        Treatment-Placebo (%)
    -3.9 (-23.2 to 15.4)
    3.9 (-15.2 to 23.0)
    -2.9 (-22.2 to 16.5)
    2.0 (-17.2 to 21.1)
    No statistical analyses for this end point

    Primary: JTE-051 Trough Plasma Concentrations

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    End point title
    		 JTE-051 Trough Plasma Concentrations [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    For Pharmacokinetic Analysis, descriptive statistics of the trough plasma concentration of JTE-051 were presented by treatment at Week 12.
    Notes
    [3] - 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: For PK data, descriptive statistics of the trough plasma concentration of JTE-051 were presented.
    [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: Trough plasma concentration of JTE-051 was measured for subjects who received the active treatment with JTE-051 only. Placebo group is not described here.
    End point values
    		 JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg
    Number of subjects analysed
    40
    42
    40
    35
    Units: ng/mL
    arithmetic mean (standard deviation)
        Concentrations (ng/mL)
    119 ( 96.9 )
    178 ( 156 )
    312 ( 252 )
    354 ( 281 )
    No statistical analyses for this end point

    Primary: Safety and tolerability of JTE-051

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    End point title
    		 Safety and tolerability of JTE-051 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Evaluation of safety and tolerability of JTE-051 has been administered for 12 weeks to subjects with active rheumatoid arthritis receiving background non-biologic DMARD therapy.
    Notes
    [5] - 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: Descriptive statistics were presented.
    End point values
    		 JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg Placebo Safety population (SAFE) JTE-051 analysis set
    Number of subjects analysed
    51
    51
    52
    51
    52
    257
    206
    Units: Patients
        Number of subjects with TEAEs
    26
    21
    32
    34
    22
    135
    113
        Number of subjects with serious TEAEs
    2
    2
    2
    1
    0
    7
    7
        Number of deaths
    0
    1
    0
    0
    0
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) included events since the first dose of JTE-051/placebo on Day 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    JTE-051 50 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 100 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 Placebo and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 150 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 Placebo) taken in the morning from the blister card.

    Reporting group title
    JTE-051 200 mg
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 50 mg, JTE-051 50 mg, JTE-051 50 mg and JTE-051 50 mg) taken in the morning from the blister card.

    Reporting group title
    Placebo
    Reporting group description
    		 Each dose consisted of 4 tablets (JTE-051 Placebo, JTE-051 Placebo, JTE-051 Placebo and JTE-051 Placebo ) taken in the morning from the blister card.

    Serious adverse events
    		 JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 52 (5.77%)
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 JTE-051 50 mg JTE-051 100 mg JTE-051 150 mg JTE-051 200 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 51 (50.98%)
    21 / 52 (40.38%)
    32 / 52 (61.54%)
    34 / 51 (66.67%)
    22 / 52 (42.31%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 52 (1.92%)
    2 / 52 (3.85%)
    9 / 51 (17.65%)
    0 / 52 (0.00%)
         occurrences all number
    2
    1
    2
    9
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 52 (1.92%)
    3 / 52 (5.77%)
    2 / 51 (3.92%)
    1 / 52 (1.92%)
         occurrences all number
    1
    1
    3
    2
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 52 (1.92%)
    6 / 52 (11.54%)
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    3
    1
    6
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 52 (1.92%)
    4 / 52 (7.69%)
    0 / 51 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    2
    1
    4
    0
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 52 (5.77%)
    5 / 52 (9.62%)
    8 / 51 (15.69%)
    2 / 52 (3.85%)
         occurrences all number
    3
    3
    5
    8
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Mar 2016
    The key changes in Protocol Amendment 1, Version 2 (dated: 24 March 2016) include the following: - The eligibility cut-off for hs-CRP was modified from >1.2 x ULN to ≥1.2 x ULN - Paragraph describing the use of non-hs-CRP as a supportive efficacy parameter was added. - Paragraph describing the currently known joint-related risks associated with NGF inhibitors and the available related information based on the JTE-051 clinical data to date was added. - Exclusion criterion #6: the unit for eGFR was modified from mL/min to mL/min/1.73 m2. - Exclusion criterion #14: note added to state that subjects with confirmed Zika infection within 4 weeks prior to the Screening Visit (Visit 1) are prohibited from participating in the study, whether or not the subjects had received antiviral therapy. - Exclusion criterion #25: this criterion was modified to add known history or suspected (according to the Investigator’s judgement) presence of RPOA, spontaneous osteonecrosis of the knee, subchondral insufficiency fractures, Kellgren grade 4 osteoarthritis or pathologic fractures to the list of exclusionary conditions. - Exclusion criterion #26: this was added as a new criterion - Exclusion criterion #34: Sickle cell disease was added as an example of hematological conditions that would exclude the subject from participating in the study. - The following conditions that would mandate removal of subjects from the study were added: total joint replacement procedure, osteonecrosis and RPOA. Additionally, a paragraph was added to state that subjects that develop signs and symptoms consistent with motor polyneuropathy, according to the neurologist’s assessment were suspended study drug dosing, pending future assessments. Decision whether the subject may restart study drug was made by the Investigator based on recommendations made by the neurologist. - Isoniazid was added to the list of medications prohibited within 3 months (12 weeks) prior to Day 1 (Visit 2) through Visit 7.

    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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