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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Two Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 to Treat Adults with At Least Moderately Active Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2021-001406-30
    Trial protocol
    		 PL  
    Global end of trial date
    29 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2025
    First version publication date
    03 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    J1V-MC-BT01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05123586
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, United States, 46825
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    29 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of 450 mg LY3361237 every 2 weeks versus placebo with respect to arthritis and/or rash remission in participants with Systemic Lupus Erythematosus (SLE) The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Mar 2022
    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: 13
    Country: Number of subjects enrolled
    Argentina: 15
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    Mexico: 15
    Worldwide total number of subjects
    85
    EEA total number of subjects
    13
    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)
    84
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 450 Milligrams (mg) - LY3361237
    Arm description
    		 Participants received 450 mg of LY3361237 administered subcutaneously (SC) every 2 weeks (Q2W) along with their usual Standard of Care (SOC) medication for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3361237
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered subcutaneously

    Number of subjects in period 1
    		450 Milligrams (mg) - LY3361237 Placebo
    Started
    42
    43
    Received At Least One Dose of Study Drug
    42
    43
    Completed
    41
    39
    Not completed
    1
    4
         Physician decision
    1
    1
         Consent withdrawn by subject
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    450 Milligrams (mg) - LY3361237
    Reporting group description
    		 Participants received 450 mg of LY3361237 administered subcutaneously (SC) every 2 weeks (Q2W) along with their usual Standard of Care (SOC) medication for 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.

    Reporting group values
    		 450 Milligrams (mg) - LY3361237 Placebo Total
    Number of subjects
    		 42 43 85
    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)
    		 41 43 84
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 38 42 80
        Male
    		 4 1 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 25 27 52
        Not Hispanic or Latino
    		 17 15 32
        Unknown or Not Reported
    		 0 1 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 7 7 14
        Asian
    		 3 3 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 3 4
        White
    		 30 30 60
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Argentina
    		 7 8 15
        United States
    		 18 19 37
        Taiwan
    		 3 2 5
        Poland
    		 6 7 13
        Mexico
    		 8 7 15

    End points

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    End points reporting groups
    Reporting group title
    450 Milligrams (mg) - LY3361237
    Reporting group description
    		 Participants received 450 mg of LY3361237 administered subcutaneously (SC) every 2 weeks (Q2W) along with their usual Standard of Care (SOC) medication for 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.

    Primary: Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash

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    End point title
    		 Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash [1]
    End point description
    Remission of arthritis and/or rash is defined by the following: if only arthritis is present at baseline, then the primary endpoint is met if arthritis is absent at Week 24; if only rash is present at baseline, then the primary endpoint is met if rash is absent at Week 24; if both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24. Analysis Population Description (APD): All participants who received at least 1 dose of study drug and had evaluable data for this outcome.
    End point type
    Primary
    End point timeframe
    Week 24
    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 inferential statistics was planned for this end point.
    End point values
    		 450 Milligrams (mg) - LY3361237 Placebo
    Number of subjects analysed
    42
    43
    Units: Percentage of participants
        number (not applicable)
    11.9
    20.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response

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    End point title
    		 Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response
    End point description
    Percentage of participants who achieved SLEDAI-4 response was assessed. A SLEDAI-4 response is defined as a ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity). APD: All participants who received at least 1 dose of the study drug and had evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 450 Milligrams (mg) - LY3361237 Placebo
    Number of subjects analysed
    42
    43
    Units: percentage of participants
        number (not applicable)
    9.5
    16.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)

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    End point title
    		 Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)
    End point description
    Percentage of participants who achieved SRI-4 response was assessed. SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of 0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. APD: All participants who received at least 1 dose of study drug and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 450 Milligrams (mg) - LY3361237 Placebo
    Number of subjects analysed
    42
    43
    Units: Percentage of participants
        number (not applicable)
    9.5
    16.3
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24

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    End point title
    		 Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24 [2]
    End point description
    PK: Steady-state trough serum concentration of LY3361237 at Week 24 was assessed. APD: All participants who received at least one dose of LY3361237 and had evaluable PK data for this outcome.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [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: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.
    End point values
    		 450 Milligrams (mg) - LY3361237
    Number of subjects analysed
    21
    Units: micrograms per milliliter (μg/mL)
        arithmetic mean (standard deviation)
    144 ( 73.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up To 25 Weeks
    Adverse event reporting additional description
    All participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    450 mg - LY3361237
    Reporting group description
    		 Participants received 450 mg of LY3361237 administered SC Q2W along with their usual SOC medication for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered SC Q2W along with their usual SOC medication for 24 weeks.

    Serious adverse events
    		 450 mg - LY3361237 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    blood glucose abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    joint dislocation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    diplopia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    volvulus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    systemic lupus erythematosus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (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: 0%
    Non-serious adverse events
    		 450 mg - LY3361237 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 42 (66.67%)
    27 / 43 (62.79%)
    Vascular disorders
    flushing
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    hysterectomy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [1]
    0 / 38 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    wisdom teeth removal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    chest discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    2
    fatigue
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    injection site reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    21
    0
    injection site pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    6 / 42 (14.29%)
    3 / 43 (6.98%)
         occurrences all number
    97
    32
    injection site oedema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    injection site bruising
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    6
    0
    injection site erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 43 (2.33%)
         occurrences all number
    14
    1
    injection site haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    seasonal allergy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    atrophic vulvovaginitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [2]
    1 / 38 (2.63%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    catarrh
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    cough
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    dysphonia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    epistaxis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    rhinitis allergic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    sinus congestion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    wheezing
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    depression
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    insomnia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Investigations
    amylase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    blood pressure increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    cardiolipin antibody positive
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    brachial plexus injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    fall
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    foot fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    head injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    joint injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    thermal burn
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Congenital, familial and genetic disorders
    polydactyly
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    dizziness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    facial paralysis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    headache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 43 (2.33%)
         occurrences all number
    9
    2
    migraine
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    paraesthesia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    tension headache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    tremor
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    antiphospholipid syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    lymphadenitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    ear pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Eye disorders
    conjunctival haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    ocular hyperaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    abdominal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    diarrhoea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    dry mouth
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    dyspepsia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    2
    food poisoning
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    gastritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    vomiting
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    dermatitis atopic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    ecchymosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    erythema nodosum
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    palmar erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    skin lesion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    skin hypopigmentation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    dysuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    haematuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    costochondritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    fibromyalgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    myalgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    joint swelling
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    tenosynovitis stenosans
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    sjogren's syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    acute sinusitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    bacterial disease carrier
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    bacterial vaginosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [3]
    0 / 38 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    covid-19
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 42 (9.52%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    candida infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    cystitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    infected dermal cyst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    influenza
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    oral herpes
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    mycoplasma infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    otitis media acute
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    pharyngitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    periodontitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    paronychia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    pharyngitis bacterial
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    postoperative wound infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    pharyngotonsillitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    sinusitis bacterial
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    sinusitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [4]
    0 / 38 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    vulvovaginitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [5]
    1 / 38 (2.63%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 42 (9.52%)
    6 / 43 (13.95%)
         occurrences all number
    5
    6
    upper respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 42 (7.14%)
    4 / 43 (9.30%)
         occurrences all number
    3
    5
    tooth abscess
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    hyperlipidaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    hyperuricaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly

    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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