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    Clinical Trial Results:
    An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients with Knee Joint Osteoarthritis

    Summary
    EudraCT number
    		 2016-001096-73
    Trial protocol
    		 BG  
    Global end of trial date
    28 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Dec 2018
    First version publication date
    12 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MIV-711-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03037489
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medivir AB
    Sponsor organisation address
    Box 1086, Huddinge, Sweden, 141 22
    Public contact
    MIV-711 Clinical Study Information, Medivir AB, clinicaloperations@medivir.com
    Scientific contact
    MIV-711 Clinical Study Information, Medivir AB, clinicaloperations@medivir.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
    16 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the safety and tolerability of 200 mg MIV-711 q.d. over 52 (26+26) weeks in patients with symptomatic and radiographic knee osteoarthritis (these patients were treated with 200 mg MIV-711 in the preceeding MIV-711-201 study, Group A). A secondary objective was to assess the safety and tolerability of 200 mg MIV-711 q.d. over 26 weeks in patients with symptomatic and radiographic knee OA (these patients received placebo in the preceeding MIV-711-201 study, Group B).
    Protection of trial subjects
    Patients were observed in the clinics during the study visits. During the whole treatment period the following safety assessments were performed at each visit: collection of adverse events and concomitant medications, vital signs, physical examination, ECG, standard safety laboratory parameters. In addition, phone calls were made in between the dosing visits to assess safety and tolerability. The last visit (at week 30) was a safety follow-up where all the above safety assessments were evaluated except physical examination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2016
    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
    Germany: 14
    Country: Number of subjects enrolled
    Georgia: 3
    Country: Number of subjects enrolled
    Moldova, Republic of: 24
    Country: Number of subjects enrolled
    Bulgaria: 9
    Worldwide total number of subjects
    50
    EEA total number of subjects
    23
    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)
    32
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in Bulgaria, Georgia, Germany and Moldova in patients previously enrolled in MIV-711-201 including completion of Visit 8 either by: • Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint OR by • Receiving placebo and had a clinically significant worsening on the primary endpoint

    Pre-assignment
    Screening details
    		 All patients in Study MIV 711 201 (Eudract No. 2015-003230-26) at the participating sites included in Study MIV-711-202 were given the opportunity to participate provided that they met the eligibility criteria. They were permitted to remain on their current analgesic regimen.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Study Group A was recruited from patients treated with 200 mg MIV-711 QD in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing for 26 additional weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIV-711
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The included excipients were microcrystalline cellulose, Starcap 1500, magnesium stearate and anhydrous colloidal silica.

    Arm title
    		 Group B
    Arm description
    		 Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 QD for the next 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIV-711
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The included excipients were microcrystalline cellulose, Starcap 1500, magnesium stearate and anhydrous colloidal silica.

    Number of subjects in period 1
    		Group A Group B
    Started
    46
    4
    Completed
    46
    4
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Study Group A was recruited from patients treated with 200 mg MIV-711 QD in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing for 26 additional weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIV-711
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The included excipients were microcrystalline cellulose, Starcap 1500, magnesium stearate and anhydrous colloidal silica.

    Arm title
    		 Group B
    Arm description
    		 Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 QD for the next 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MIV-711
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    The included excipients were microcrystalline cellulose, Starcap 1500, magnesium stearate and anhydrous colloidal silica.

    Number of subjects in period 2
    		Group A Group B
    Started
    46
    4
    Completed
    39
    4
    Not completed
    7
    0
         Consent withdrawn by subject
    3
    -
         Adverse event, non-fatal
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Study Group A was recruited from patients treated with 200 mg MIV-711 QD in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing for 26 additional weeks.

    Reporting group title
    Group B
    Reporting group description
    		 Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 QD for the next 26 weeks.

    Reporting group values
    		 Group A Group B Total
    Number of subjects
    		 46 4 50
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 30 2 32
        From 65-84 years
    		 16 2 18
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.5 ( 7.52 ) 65.5 ( 5.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 3 34
        Male
    		 15 1 16

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Study Group A was recruited from patients treated with 200 mg MIV-711 QD in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing for 26 additional weeks.

    Reporting group title
    Group B
    Reporting group description
    		 Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 QD for the next 26 weeks.
    Reporting group title
    Group A
    Reporting group description
    		 Study Group A was recruited from patients treated with 200 mg MIV-711 QD in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing for 26 additional weeks.

    Reporting group title
    Group B
    Reporting group description
    		 Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 QD for the next 26 weeks.

    Primary: Patients with any treatment emergent adverse events (TEAEs)

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    End point title
    		 Patients with any treatment emergent adverse events (TEAEs) [1]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 until safety follow-up
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: Number of patients with any TEAE
    21
    2
    No statistical analyses for this end point

    Primary: Patients with any Serious Adverse Events (SAEs)

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    End point title
    		 Patients with any Serious Adverse Events (SAEs) [2]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 to the safety follow-up visit
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: Number of patients with any SAEs
    2
    0
    No statistical analyses for this end point

    Primary: Patients with related TEAEs

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    End point title
    		 Patients with related TEAEs [3]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 to the safety follow-up visit
    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: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: Number of patients with any related TEAE
    1
    0
    No statistical analyses for this end point

    Primary: Patients with mild TEAEs

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    End point title
    		 Patients with mild TEAEs [4]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 to the safety follow-up visit.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: Number of patients with mild TEAEs
    6
    1
    No statistical analyses for this end point

    Primary: Patients with moderate TEAEs

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    End point title
    		 Patients with moderate TEAEs [5]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 to the safety follow-up visit
    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: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: Number of patients with moderate TEAEs
    14
    1
    No statistical analyses for this end point

    Primary: Patients with severe TEAEs

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    End point title
    		 Patients with severe TEAEs [6]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 to the safety follow-up visit
    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: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: Number of patients with severe TEAEs
    1
    0
    No statistical analyses for this end point

    Primary: Patients with TEAEs leading to early discontinuation

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    End point title
    		 Patients with TEAEs leading to early discontinuation [7]
    End point description
    End point type
    Primary
    End point timeframe
    From visit 2 to the safety follow-up visit
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was done for the study. Only descriptive results are available.
    End point values
    		 Group A Group B
    Number of subjects analysed
    46
    4
    Units: No of pats with TEAEs leading to discon
    4
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from visit 2 in MIV-711-202 to the safety follow-up visit.
    Adverse event reporting additional description
    This study reports treatment-emergent AEs (TEAEs). A TEAE was difined as an AE that begins or that worsens in severity after at least one dose of IMP has been administered.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A received MIV-711 200 mg once daily in the preceeding study MIV-711-201.

    Reporting group title
    Group B
    Reporting group description
    		 Group B received placebo in the preceeding study MIV-711-201.

    Serious adverse events
    		 Group A Group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenitis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Group A Group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 46 (28.26%)
    2 / 4 (50.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Chronic gastritis
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Duodenal ulcer
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 4 (25.00%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 4 (0.00%)
         occurrences all number
    2
    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
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    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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