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    Clinical Trial Results:
    A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2015-003341-25
    Trial protocol
    		 HU   DE   FR   GB   IT  
    Global end of trial date
    24 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2019
    First version publication date
    09 Feb 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IPP-201101/005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02504645
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ImmuPharma France SA
    Sponsor organisation address
    5, rue du Rhône, 68100, France,
    Public contact
    Robert Zimmer, ImmuPharma SA, 00 33 (0)6 18 22 16 50, robert.zimmer@immupharma.com
    Scientific contact
    Robert Zimmer, ImmuPharma SA, 00 33 (0)6 18 22 16 50, robert.zimmer@immupharma.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
    11 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of a 200-mcg dose every 4 weeks for 48 weeks of IPP-201101 compared with placebo in patients with active systemic lupus erythematosus (SLE) as assessed by the SLE responder index (SRI) at week 52.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2015
    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
    Poland: 32
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 24
    Country: Number of subjects enrolled
    United States: 73
    Country: Number of subjects enrolled
    Mauritius: 49
    Worldwide total number of subjects
    204
    EEA total number of subjects
    82
    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)
    204
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants should fulfilled study eligibility criteria to be randomized.

    Pre-assignment
    Screening details
    		 303 participants were enrolled and 204 were randomized. 2 were randomized but not treated. The 99 who were not randomised did not meet study entry criteria.

    Period 1
    Period 1 title
    Overall trial (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
    		 Standard of care + 200 mcg SC IPP-201101
    Arm description
    		 200 mcg SC IPP-201101 every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPP-201101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mcg administered subcutaneoulsy every 4 weeks.

    Arm title
    		 Standard of care + Placebo SC
    Arm description
    		 Placebo was administered subcutaneously every 4 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered subcutaneously every 4 weeks

    Number of subjects in period 1
    		Standard of care + 200 mcg SC IPP-201101 Standard of care + Placebo SC
    Started
    101
    103
    Completed
    77
    76
    Not completed
    24
    27
         Consent withdrawn by subject
    6
    6
         Adverse event, non-fatal
    6
    3
         Other
    5
    4
         Pregnancy
    1
    2
         Lost to follow-up
    2
    4
         Protocol deviation
    2
    4
         Lack of efficacy
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of care + 200 mcg SC IPP-201101
    Reporting group description
    		 200 mcg SC IPP-201101 every 4 weeks

    Reporting group title
    Standard of care + Placebo SC
    Reporting group description
    		 Placebo was administered subcutaneously every 4 weeks

    Reporting group values
    		 Standard of care + 200 mcg SC IPP-201101 Standard of care + Placebo SC Total
    Number of subjects
    		 101 103 204
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 101 103 204
    Age continuous
    Units: years
        median (standard deviation)
    		 42.55 ± 11.86 43.69 ± 11.49 -
    Gender categorical
    Units: Subjects
        Female
    		 96 94 190
        Male
    		 5 9 14
    Race
    Units: Subjects
        White
    		 59 66 125
        Black or African American
    		 14 10 24
        Native Hawaiian or Other Pacific Islander
    		 0 2 2
        Asian
    		 4 1 5
        Other
    		 24 24 48
        American Indian or Alaska Native
    		 0 0 0
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 88 84 172
        Hispanic or Latino
    		 13 19 32

    End points

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    End points reporting groups
    Reporting group title
    Standard of care + 200 mcg SC IPP-201101
    Reporting group description
    		 200 mcg SC IPP-201101 every 4 weeks

    Reporting group title
    Standard of care + Placebo SC
    Reporting group description
    		 Placebo was administered subcutaneously every 4 weeks

    Primary: Proportion of patients responders using the SRI at week 52

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    End point title
    		 Proportion of patients responders using the SRI at week 52
    End point description
    A SRI response was defined as a reduction from baseline in the SLEDAI-2K score of at least 4 points, no worsening in PhGA (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new BILAG A body system score, and no more than 1 new BILAG B body system score from baseline.
    End point type
    Primary
    End point timeframe
    At week 52
    End point values
    		 Standard of care + 200 mcg SC IPP-201101 Standard of care + Placebo SC
    Number of subjects analysed
    101
    101
    Units: patients
        responders
    53
    45
    Statistical analysis title
    		 Primary Analysis of SRI Response at Week 52
    Comparison groups
    Standard of care + Placebo SC v Standard of care + 200 mcg SC IPP-201101
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2631
    Method
    		 Chi-squared
    Confidence interval

    Post-hoc: Proportion of reponders of EU patients having anti-dsDNA at randomization

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    End point title
    		 Proportion of reponders of EU patients having anti-dsDNA at randomization
    End point description
    End point type
    Post-hoc
    End point timeframe
    At week 52
    End point values
    		 Standard of care + 200 mcg SC IPP-201101 Standard of care + Placebo SC
    Number of subjects analysed
    52
    55
    Units: patient
        Responders
    32
    26
    Statistical analysis title
    		 Post Hoc analysis
    Comparison groups
    Standard of care + Placebo SC v Standard of care + 200 mcg SC IPP-201101
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0218
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) and serious adverse events (SAEs) are reported from informed consent signature and up to 30 days post last dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Standard of care + IPP-201101 SC 200 mcg
    Reporting group description
    		 -

    Reporting group title
    Standard of care + Placebo SC
    Reporting group description
    		 -

    Serious adverse events
    		 Standard of care + IPP-201101 SC 200 mcg Standard of care + Placebo SC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 101 (12.87%)
    16 / 101 (15.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Mesothelioma malignant
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 101 (2.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Face Edema
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic fluid collection
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Hemorrhage
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (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
    Pleural effusion
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural Hematoma
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoesthesia
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Butterfly rash
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous lupus erythematosus
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hematuria
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 101 (0.99%)
         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
    		 Standard of care + IPP-201101 SC 200 mcg Standard of care + Placebo SC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 101 (93.07%)
    96 / 101 (95.05%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 101 (2.97%)
    7 / 101 (6.93%)
         occurrences all number
    4
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 101 (11.88%)
    17 / 101 (16.83%)
         occurrences all number
    18
    31
    Migraine
         subjects affected / exposed
    5 / 101 (4.95%)
    1 / 101 (0.99%)
         occurrences all number
    5
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    8 / 101 (7.92%)
    7 / 101 (6.93%)
         occurrences all number
    9
    11
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    5 / 101 (4.95%)
    0 / 101 (0.00%)
         occurrences all number
    21
    0
    Mucosal ulceration
         subjects affected / exposed
    4 / 101 (3.96%)
    8 / 101 (7.92%)
         occurrences all number
    9
    8
    Pyrexia
         subjects affected / exposed
    5 / 101 (4.95%)
    5 / 101 (4.95%)
         occurrences all number
    8
    6
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    6 / 101 (5.94%)
    7 / 101 (6.93%)
         occurrences all number
    8
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 101 (5.94%)
    2 / 101 (1.98%)
         occurrences all number
    8
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 101 (5.94%)
         occurrences all number
    3
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    12 / 101 (11.88%)
    13 / 101 (12.87%)
         occurrences all number
    17
    15
    Rash
         subjects affected / exposed
    12 / 101 (11.88%)
    8 / 101 (7.92%)
         occurrences all number
    14
    13
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 101 (5.94%)
         occurrences all number
    3
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 101 (11.88%)
    13 / 101 (12.87%)
         occurrences all number
    13
    19
    Arthritis
         subjects affected / exposed
    15 / 101 (14.85%)
    14 / 101 (13.86%)
         occurrences all number
    25
    27
    Back pain
         subjects affected / exposed
    9 / 101 (8.91%)
    9 / 101 (8.91%)
         occurrences all number
    9
    10
    Myalgia
         subjects affected / exposed
    6 / 101 (5.94%)
    1 / 101 (0.99%)
         occurrences all number
    7
    1
    Systemic lupus erythematosus
         subjects affected / exposed
    2 / 101 (1.98%)
    10 / 101 (9.90%)
         occurrences all number
    2
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    7 / 101 (6.93%)
    8 / 101 (7.92%)
         occurrences all number
    7
    8
    Nasopharyngitis
         subjects affected / exposed
    8 / 101 (7.92%)
    7 / 101 (6.93%)
         occurrences all number
    14
    8
    Pharyngitis
         subjects affected / exposed
    2 / 101 (1.98%)
    5 / 101 (4.95%)
         occurrences all number
    2
    5
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 101 (19.80%)
    28 / 101 (27.72%)
         occurrences all number
    25
    32
    Urinary tract infection
         subjects affected / exposed
    23 / 101 (22.77%)
    10 / 101 (9.90%)
         occurrences all number
    32
    19

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jun 2016
    Exclusion criteria “(e)” updated to clarify wash out period in case of use of B-cell depleting agent

    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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