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    Summary
    EudraCT Number:2017-003051-35
    Sponsor's Protocol Code Number:DER-201701
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2017-003051-35
    A.3Full title of the trial
    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)
    Wirksamkeit von BELImumab bei therapieresistenten Hautmanifestationen bei Patienten mit Lupus erythematodes (LE): Eine Phase IIII, multizentrische, ran-domisierte, doppel-blinde, Placebo-kontrollierte, 24-wöchige Untersuchung (BELI-SKIN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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)
    Wirksamkeit von BELImumab bei therapieresistenten Hautmanifestationen bei Patienten mit Lupus erythematodes (LE): Eine Phase III, multizentrische, ran-domisierte, doppel-blinde, Placebo-kontrollierte, 24-wöchige Untersuchung (BELI-SKIN)
    A.3.2Name or abbreviated title of the trial where available
    BELI-SKIN
    A.4.1Sponsor's protocol code numberDER-201701
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRheinische Friedrich-Wilhelms-Universität Bonn
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline plc. (GSK)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStudienzentrale Studienzentrum Bonn (SZB)
    B.5.2Functional name of contact pointVerena Proß
    B.5.3 Address:
    B.5.3.1Street AddressVenusberg-Campus 1
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53127
    B.5.3.4CountryGermany
    B.5.4Telephone number0049228287 13917
    B.5.5Fax number0049228287 16039
    B.5.6E-mailverena.pross@ukbonn.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Belimumab
    D.2.1.1.2Name of the Marketing Authorisation holder GlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBelimumab
    D.3.2Product code AS (GSK1550188)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with lupus erythematosus (LE) with active, therapy-resistant skin manifestations receiving Standard of Care (SOC) therapy
    Patienten mit Lupus erythematodes (LE) mit aktiven, therapieresistenten Hautmanifestationen unter Standardtherapie
    E.1.1.1Medical condition in easily understood language
    Patients with lupus erythematosus (LE) with active, therapy-resistant skin manifestations receiving Standard of Care (SOC) therapy
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10025135
    E.1.2Term Lupus erythematosus (incl subtypes)
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025134
    E.1.2Term Lupus erythematosus
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of belimumab for therapy-resistant LE-specific skin manifestations of LE patients under Standard of Care (SOC) therapy
    Evaluation der Wirksamkeit von Belimumab bei therapieresistenten LE-spezifischen Hautmanifestationen
    E.2.2Secondary objectives of the trial
    To assess whether the administration of belimumab in active, therapy-resistant skin manifestations of LE-patients under Standard of Care (SOC) therapy is associated with reduced concurrent medication.
    To assess whether the administration of belimumab in active, therapy-resistant skin manifestations of LE-patients under Standard of Care (SOC) therapy is associated with a reduction of inflammatory parameters in skin lesions and serum.
    Überprüfung, ob die Gabe von Belimumab in aktiven, therapieresistenten Hautmanifestationen von LE-Patienten unter Standardtherapie mit einer Redu-zierung der Begleitmedikation assoziiert ist
    Überprüfung, ob die Gabe von Belimumab in aktiven, therapieresistenten Hautmanifestationen von LE-Patienten unter Standardtherapie mit einer Abnahme entzündlicher Parameter in Hautläsionen und im Serum verbunden ist.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age
    2. Patients with a clinically and histologically confirmed diagnosis of LE-specific skin lesions
    3. Patients with active skin manifestations at time of enrolment
    4. Patients who meet at least two of the American College of Rheumatology (ACR) criteria for LE (≥ 2 criteria) (Patients with cutaneous forms of LE
    without systemic involvement who meet all inclusion criteria may be in-cluded)
    5. Patients with positive ANA (titre ≥ 1:80, at least once within the last 3 years (no longer applicable after amendment 3)
    6. Total RCLASI skin activity score of ≥ 6
    7. Patients receiving stable standard therapy for at least 30 days prior to day 0; corticosteroids may have been added as new medication or dose ad-justed up to 30 days prior to day 0; new LE therapy, other than cortico-steroids, were not added within 60 days prior to day 0; permitted medica-tions for stable standard therapy alone or in combination included:
    o Systemic prednisone or its equivalent up to 40 mg/day and/or class I, II, or III; topical corticosteroids up to 2 times a day (lesional applica-tion only)
    o antimalarials including hydroxychloroquine, chloroquine or quinacrine
    o non-steroidal anti-inflammatory agents (NSAID)
    o immunosuppressive or immunomodulatory agents including metho-trexate, azathioprine, dapsone, leflunomide, mycophenolate (includ-ing mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g., tacrolimus, cyclo-sporine), sirolimus, 6-mercaptopurine or thalidomide and/or topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) up to 2 times a day (lesional application only)
    o Please note: Topical corticosteroids (class I, II, or III up to 2 times a day with lesional application only) or topical calcineurin inhibitors (such as tacrolimus or pimecrolimus, up to 2 times a day with lesional appli-cation only) as the only Standard of Care medication is exclusively permitted in localized CLE disease (in accordance with the EADV s2k guideline4). For severe and widespread skin manifestations, a purely topical therapy is not sufficient as SOC.
    8. Subjects with the ability to follow study instructions and likely to attend and complete all required visits
    9. Written informed consent of the subject
    E.4Principal exclusion criteria
     Subj not able to give consent  Subj without legal capacity who is unable to understand the nature,scope, significance a consequences of this clinical trial  Known history of hypersens to the IMP or to drugs with a similar chem structure  Simultaneous particip in another interventional CT or particip in any CT involving admin of an IMP/biological agent within 60 d prior to CT beginning  Subj with a physical or psychiatric condition which at investig's discretion may put the subj at risk, may confound the trial results, or may interfere with the subj's particip in this CT  Known or persistent abuse of medication, drugs or alcohol within 365 d prior to d 0  Current or planned pregnancy or nursing women  Females of childbearing potential, who are not using and not willing to use medically reliable methods of contracep for the entire study duration unless they are surgically sterilized/ hysterectomized or there are any other criteria considered sufficiently reliable by the investig in individual cases  Pat with a
    history of malignant neoplasm within the last 5 y with the exception of basal cell or squamous cell carcinoma of skin treated with local resection only or carcinoma in situ of uterine cervix treated locally and with no evidence of metastatic disease for 3 y  Pat with evidence of serious
    suicide risk incl any history of suicidal behavior in the last 6 mo and/or any suicidal ideation ≥ 4 on the CSSRS ideation scale in the last 2 mo or
    who in the investig's judgment pose a significant suicide risk  Pat who have required high-dose prednisone (>100 mg/day) or its equivalent
    within 90 d prior to d 0  Severe lupus kidney disease (proturia >6 g/24 h or equivalent using spot urine protein to creatinine ratio, or serum
    creatinine >2.5 mg/dL), active nephritis or have required hemodialysis or high-dose prednisone (>100 mg/day) within 90 d prior to d 0 
    Active central nervous system lupus, incl seizures, psychosis, organic brain syndrome,cerebrovascular accident, cerebritis or CNS vasculitis,
    that required therapeutic intervention within 60 days prior to day 0  History of a major organ transpl or hematopoietic stem cell/marrow
    transplant  Previous treat with intravenous IG up to 3 mo fore enrolment  Previous treat with belimumab or any investigational
    biologic agent within 1 year before enrolment or an investigational non biologic agent within 60 days or 5 pharmacokinetic half-lives (whichever
    is longer) prior to enrol  Treatm with immunomodulating drugs for other reasons than LE within 60 d prior to d 0  Active skin disease
    other than LE-specific or LE-non-specific manifesta  Pat previously hypersensitive to B-lymphocyte-targeted drug (incl rituximab) or
    Belimumab  Currently on any suppressive therapy for a chronic infection (eg tuberculosis,pneumocystis, cytomegalovirus,..)  Hospitaliz for treatm of infection within 60 d prior to Day 0.  Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, antifungals or anti-parasitic agents) within 60 days prior to Day 0  Pat with a historically pos HIV test or test pos at screening for HIV  Serologic evidence of current or past HepB infection based on positive testing for HBsAg or HBcAb.  Positive test for HepC antibody  Pat with a history of a prim immunodeficiency  Pat with a significant IgG deficiency (IgG level < 400 mg/dL)  Pat with an IgA deficiency (IgA level < 10 mg/dL)  Have a history of an anaphyl reaction to parenteral admin of contrast agents, human or murine proteins or monoclonal antibodies
    • Pat with ALT/GPT and/or AST/GOT≥3xULN
    •Pat with bilirubin≥1,5xULN
     Have any other clinically sign abnorm lab value in the opinion of the investig  Anti-B-cell therapy: Wash out of 5 therap half-lives after Bcell
    therapy, or until pharmacodynamic effect would be minimal, is mandatory before day 0  365days prior to belimumab: Any biologic
    investigat agent (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131)  30 Days Prior to belimumab (or 5 half-lives, whichever is
    greater): Any non-biologic investig agent. Investiga agent applies to any drug not approved for sale in the country in which it is being used  Live vaccines within 30 days prior to baseline or concurrently with belimumab
     Until 90 days prior to belimumab administration: intravenous and oral cy-clophosphamide intake
    New exclusion criteria according to amendments:
     Patients with neutrophils <1.5X109/L (amendment 4)
    E.5 End points
    E.5.1Primary end point(s)
    • Differences in relative change of the mean RCLASI activity score after 24 weeks (V8) between placebo- and treatment-arm
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks (V8)
    E.5.2Secondary end point(s)
     Change to baseline in the RCLASI activity score after 7, 28, 56, 84, 112, 140 and 168 days of treatment in both arms
     Change to baseline in the RCLASI skin activity score after 7, 28, 56, 84,112,140 and 168 days of treatment in both arms
     Change to baseline in the RCLASI alopecia activity score after 7, 28, 56, 84, 112, 140 and 168 days of treatment in both arms
     Change to baseline in the RCLASI mucous membrane lesions activity score after 7, 28, 56, 84, 112, 140 and 168 days of treatment in both arms
     Change to baseline in the SELENA-SLEDAI score after 56 and 168 days of treatment in both arms
     Change in consumption of concurrent medication after 7, 28, 56, 84, 112, 140 and 168 days of treatment in both arms
     Change in CSSRS scores after 7, 28, 56, 84,112,140 and 168 days of treatment in both arms
     Change to baseline in Dermatology Life Quality Index (DLQI) score and Beck Depression Inventory II (BDI-II) score after 56 and 168 days of treatment in both arms
     Change of lesional histological inflammation score (V0 vs V8)
     Change of lesional MxA expression (IFN-score; V0 vs V8)
     Change in gene expression profile (serum; V0 vs. V8)
     Occurrence of any adverse event (including changes in laboratory test parameters)
     Change to baseline in the RCLASI total activity score, skin activity, alope-cia activity, and mucous membrane lesions activity score at VOL-1, VOL-2, VOL-3, and Safety FU in both arms
     Change to baseline in the SELENA-SLEDAI score, DLQI score, CSSRS scores, and BDI-II score at VOL-1, VOL-2, and VOL-3 in both arms
     Change in consumption of concurrent medication at VOL-1, VOL-2, and VOL-3 in both arms
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint(s) of evaluation of secondardy end point see E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    optional: 24 weeks in the open-label extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No specific post-study arrangements are made and no specific post-study care will be performed after this study. All subjects will return to their standard medical care after the study, as needed. This also applies to subjects who withdraw their consent during the course of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-17
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