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    Clinical Trial Results:
    A Phase 2, Double Blind, Placebo Controlled Study of RSLV-132 in Subjects with Primary Sjogren’s Syndrome

    Summary
    EudraCT number
    		 2016-001586-87
    Trial protocol
    		 GB  
    Global end of trial date
    28 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2020
    First version publication date
    17 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RSLV-132-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03247686
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Resolve Therapeutics LLC
    Sponsor organisation address
    721 1st Avenue North , St. Petersburg, FL 33701, United States,
    Public contact
    Chief Executive Officer, Resolve Therapeutics, LLC, 001 208727 7010, jp@resolvebio.com
    Scientific contact
    Chief Executive Officer, Resolve Therapeutics, LLC, 2087277010 208727 7010, jp@resolvebio.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
    02 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary endpoint of the study is to assess changes in blood cell gene expression or serum protein levels indicative of reduced inflammation in the active versus control groups.
    Protection of trial subjects
    Standard procedures for emergency care were followed for any individual adverse events if clinically needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 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
    United Kingdom: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    20
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Potential participant were screened to assess their eligibility within 60 days prior to study entry. Eligible participants were randomized in a 3:1 ratio to either RSLV-132 or placebo. A total of 22 participants were randomised to RSLV-2 and 8 to placebo. Two participants randomized to RSLV-2 were withdrawn prior to the start of study treatment.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Placebo was administered as an IV infusion with an initial infusion rate of 167 mL/hour and over approximately 90 minutes.

    Arm title
    		 RSLV-132
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSLV-132
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    RSLV-132 was administered as IV infusions with an initial infusion rate of 167 mL/hour and over approximately 90 minutes.

    Number of subjects in period 1
    		Placebo RSLV-132
    Started
    8
    20
    Completed
    7
    18
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    RSLV-132
    Reporting group description
    		 -

    Reporting group values
    		 Placebo RSLV-132 Total
    Number of subjects
    		 8 20 28
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.6 ± 8.8 56.5 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    		 8 20 28
        Male
    		 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 8 19 27
        Unknown or Not Reported
    		 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 1 2
        Native Hawaiian or other Pacific Islander
    		 0 0 0
        White
    		 7 19 26
        More than One Race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
        Black or African American
    		 0 0 0
    EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) Total Score
    Units: total score
        arithmetic mean (standard deviation)
    		 5.1 ± 4.1 5.0 ± 4.6 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    RSLV-132
    Reporting group description
    		 -

    Primary: Blood Cell Gene Expression

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    End point title
    		 Blood Cell Gene Expression
    End point description
    End point type
    Primary
    End point timeframe
    Day 99
    End point values
    		 Placebo RSLV-132
    Number of subjects analysed
    7
    20
    Units: log2 fold change from baseline
    arithmetic mean (standard error)
        Module M1.2
    -0.0291486 ± 0.1151235
    0.1330903 ± 0.09136563
        Module M3.4
    -0.0301788 ± 0.1362689
    0.08489987 ± 0.08673372
        Module M5.12
    -0.0572555 ± 0.09889587
    0.02757946 ± 0.1279434
    Statistical analysis title
    		 Module M1.2 Placebo versus RSLV-132 All
    Comparison groups
    Placebo v RSLV-132
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00005
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Module M3.4 Placebo versus RSLV-132 All
    Comparison groups
    Placebo v RSLV-132
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Module 5.12 Placebo versus RSLV-132 All
    Comparison groups
    Placebo v RSLV-132
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00044
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: EULAR ESSDAI Total Score

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    End point title
    		 EULAR ESSDAI Total Score
    End point description
    End point type
    Secondary
    End point timeframe
    Day 99
    End point values
    		 Placebo RSLV-132
    Number of subjects analysed
    8
    20
    Units: Change from Baseline in Total Score
        arithmetic mean (standard deviation)
    -2.5 ± 4.3
    0.0 ± 3.8
    Statistical analysis title
    		 Mean difference in Change from Baseline (95% CI)
    Comparison groups
    Placebo v RSLV-132
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.18
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.34
         upper limit
    		 1.34
    Notes
    [1] - Two sample t-test with Satterthwaite approximation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening until Day 211
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    RSLV-132
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo RSLV-132
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Parotitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo RSLV-132
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    20 / 20 (100.00%)
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 20 (30.00%)
         occurrences all number
    1
    7
    Oedema peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Mood altered
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Sleep disorder
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Joint injury
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Thermal burn
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 20 (15.00%)
         occurrences all number
    1
    4
    Presyncope
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Sensorimotor disorder
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Rash papular
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    5 / 20 (25.00%)
         occurrences all number
    0
    5
    Joint swelling
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Limb discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Osteoarthritis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Palindromic rheumatism
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Sjogren's syndrome
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Tendonitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 20 (15.00%)
         occurrences all number
    1
    4
    Gastroenteritis viral
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 8 (37.50%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Parotitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    Viral infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 20 (20.00%)
         occurrences all number
    1
    6
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 8 (25.00%)
    5 / 20 (25.00%)
         occurrences all number
    3
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    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.
    None reported
    For support, Contact us.
    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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