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    Clinical Trial Results:
    Efficacy of BELImumab for therapy-resistant SKIN manifestations in patients with lupus erythematosus (LE): A phase III, multicenter, randomized, double-blind, placebo-controlled, 24-week trial (BELI-SKIN)

    Summary
    EudraCT number
    		 2017-003051-35
    Trial protocol
    		 DE  
    Global end of trial date
    17 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2025
    First version publication date
    07 Aug 2025
    Other versions
    Summary report(s)
    		 Clinical Study Report_BELISKIN

    Trial information

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    Trial identification
    Sponsor protocol code
    DER-201701
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rheinische Friedrich-Wilhelms-Universität Bonn
    Sponsor organisation address
    Venusberg-Campus 1, Bonn, Germany, 53127
    Public contact
    Verena Proß, Studienzentrale des Studienzentrum Bonn (SZB), 0049 228287 16046, studienzentrale-szb@ukbonn.de
    Scientific contact
    Prof. Dr. med. Joerg Wenzel, Zentrum für Hauterkrankungen Klinik für Dermatologie & Allergologie Universitätsklinikum Bonn, 0049 22828715370, joerg.wenzel@ukbonn.de
    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 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of belimumab for therapy-resistant LE-specific skin manifestations of LE patients under Standard of Care therapy
    Protection of trial subjects
    The IMP has already been authorized for the treatment of systemic lupus erythematodes as a supplement to standard therapy. The investigator informed the patients about the trial in detail and both signed the informed consent form. A patient insurance was in place. Adverse events were documented regularly.
    Background therapy
    		 The patients will receive standard care according to the diagnosis lupus erythematodes and concomitant disease conditions based on EBM standards and good-clinical practice within the participating departments.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2019
    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
    Germany: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    60
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 FPI to LPI: 04.02.2019 to 31.10.2022 in 9 German trial sites

    Pre-assignment
    Screening details
    		 After obtaining the signed written informed consent from a potential LE patient, trial sites will perform screening examinations and will check inclusion/exclusion criteria. After successful screening the patient is randomized centrally using the eCRF interactive web-based response system (IWRS) where the randomization number is assigned.

    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
    Blinding implementation details
    This trial is double-blinded. After randomization neither the patients nor the investigator or sponsor will be aware of the treatment allocation. Patients assigned to one of the double-blinded treatments receive subcutaneous injection of belimumb or matching placebo. The syringes for subcutaneous injection will be identical in appearance. The IMP will be packed and delivered from manufacturer to the centres via central pharmacy. This will ensure double-blind conditions. The preparing sequence

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Belimumab
    Arm description
    		 weekly subcutaneous injection of 200mg belimumab
    Arm type
    		 single

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Benlysta®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Dose: 200 mg weekly for 24 weeks followed by an open-label extension: optional 24 weeks treatment with 200 mg belimumab weekly

    Arm title
    		 Placebo
    Arm description
    		 weekly subcutaneous injection of matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Benlysta®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Dose: 200 mg weekly for 24 weeks followed by an open-label extension: optional 24 weeks treatment with 200 mg belimumab weekly

    Number of subjects in period 1
    		Belimumab Placebo
    Started
    35
    35
    Completed
    30
    32
    Not completed
    5
    3
         Adverse event, serious fatal
    -
    2
         Consent withdrawn by subject
    2
    -
         not known
    2
    1
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Belimumab
    Reporting group description
    		 weekly subcutaneous injection of 200mg belimumab

    Reporting group title
    Placebo
    Reporting group description
    		 weekly subcutaneous injection of matching placebo

    Reporting group values
    		 Belimumab Placebo Total
    Number of subjects
    		 35 35 70
    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 30 60
        From 65-84 years
    		 5 5 10
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.6 ( 14.1 ) 49.9 ( 12.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 23 52
        Male
    		 6 12 18

    End points

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    End points reporting groups
    Reporting group title
    Belimumab
    Reporting group description
    		 weekly subcutaneous injection of 200mg belimumab

    Reporting group title
    Placebo
    Reporting group description
    		 weekly subcutaneous injection of matching placebo

    Primary: Differences in relative change of the mean RCLASI activity score after 168 days (V8) between placebo- and treatment-arm

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    End point title
    		 Differences in relative change of the mean RCLASI activity score after 168 days (V8) between placebo- and treatment-arm
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 168 days (V8)
    End point values
    		 Belimumab Placebo
    Number of subjects analysed
    35
    34
    Units: Activity Overall Score
        arithmetic mean (confidence interval 95%)
    -0.33 (-0.44 to -0.22)
    -0.21 (-0.43 to 0.004)
    Statistical analysis title
    		 Repeted measure model
    Comparison groups
    Belimumab v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.114
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.057
         upper limit
    		 0.285
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.087
    Notes
    [1] - non significant

    Secondary: Change to baseline in the SELENA-SLEDAI score after 56 and 168 days of treatment in both arms

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    End point title
    		 Change to baseline in the SELENA-SLEDAI score after 56 and 168 days of treatment in both arms
    End point description
    Results presented only relative changes for day 168. Absoulut and relative changes are calculated. Results for other time points please see attached summary
    End point type
    Secondary
    End point timeframe
    baseline to 168 days
    End point values
    		 Belimumab Placebo
    Number of subjects analysed
    34
    35
    Units: Score
        arithmetic mean (confidence interval 95%)
    0.04 (-0.32 to 0.40)
    0.11 (-0.27 to 0.50)
    No statistical analyses for this end point

    Secondary: Change to baseline in Dermatology Life Quality Index (DLQI) score after 56 and 168 days of treatment in both arms

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    End point title
    		 Change to baseline in Dermatology Life Quality Index (DLQI) score after 56 and 168 days of treatment in both arms
    End point description
    Results presented only relative changes for day 168. Absoulut and relative changes are calculated. Results for other time points please see attached summary
    End point type
    Secondary
    End point timeframe
    baseline to day 168
    End point values
    		 Belimumab Placebo
    Number of subjects analysed
    34
    35
    Units: Score
        arithmetic mean (confidence interval 95%)
    -0.15 (-0.44 to 0.15)
    0.01 (-0.40 to 0.41)
    No statistical analyses for this end point

    Secondary: Change to baseline in Beck Depression Inventory II (BDI-II) score after 56 and 168 days of treatment in both arms

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    End point title
    		 Change to baseline in Beck Depression Inventory II (BDI-II) score after 56 and 168 days of treatment in both arms
    End point description
    Results presented only relative changes for day 168. Absoulut and relative changes are calculated. Results for other time points please see attached summary
    End point type
    Secondary
    End point timeframe
    baseline to day 168
    End point values
    		 Belimumab Placebo
    Number of subjects analysed
    34
    35
    Units: Score
        arithmetic mean (confidence interval 95%)
    0.10 (-0.31 to 0.52)
    -0.09 (-0.42 to 0.24)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to day 168
    Adverse event reporting additional description
    Safety reproting started after first IMP administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Blinded period_Belimumab
    Reporting group description
    		 -

    Reporting group title
    Blinded period_Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Blinded period_Belimumab Blinded period_Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Eye disorders
    Ocular vein thrombosis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute renal failure
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Deterioration of SLE
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Blinded period_Belimumab Blinded period_Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 34 (88.24%)
    31 / 35 (88.57%)
    Investigations
    Increased blood pressure
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 34 (11.76%)
    5 / 35 (14.29%)
         occurrences all number
    4
    5
    Migraine
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 34 (0.00%)
    4 / 35 (11.43%)
         occurrences all number
    0
    4
    Peripheral swelling
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    menstrual problems
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Abdominal complaints
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 35 (5.71%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgie
         subjects affected / exposed
    2 / 34 (5.88%)
    5 / 35 (14.29%)
         occurrences all number
    2
    5
    Myalgia
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Pain in one extremity
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Coronavirus infection
         subjects affected / exposed
    7 / 34 (20.59%)
    4 / 35 (11.43%)
         occurrences all number
    7
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 35 (8.57%)
         occurrences all number
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 34 (11.76%)
    7 / 35 (20.00%)
         occurrences all number
    4
    7
    Pulpitis dentalis
         subjects affected / exposed
    0 / 34 (0.00%)
    5 / 35 (14.29%)
         occurrences all number
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2018
    Protocol Amendment (V3.0) due to ethics requests
    27 Feb 2019
    Protocol (V4.0) and ICF Amendment, Addition of 2 new trial sites, deregistration of one trial site, change of deputy in one trial site
    25 Jul 2019
    Protocol (V5.0) and Synopsis Amendment, Update Labeling and IB, new Deputy in one trial site
    24 Jul 2020
    Protocol (V6.0) and ICF amendment, Update IB
    05 Jan 2021
    Protocol (V7.0) and Synopse amendment, prolongation of recruitment period; update of import authorisation and QP-declaration due to Brexit
    10 Dec 2021
    Protocol (V8.0) and Synopse amendment, Additional trial site, Update IB
    05 Jan 2023
    Changed manufacturing process of the placebo
    05 Sep 2023
    Update IB and deregistration of two trial sites

    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
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