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    Summary
    EudraCT Number:2010-023396-25
    Sponsor's Protocol Code Number:SM101-201-sle-10
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-23
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-023396-25
    A.3Full title of the trial
    Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)
    A.3.2Name or abbreviated title of the trial where available
    SMILE
    A.4.1Sponsor's protocol code numberSM101-201-sle-10
    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 SponsorSuppreMol GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSuppremol GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSuppremol GmbH
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street AddressAm Klopferspitz 19
    B.5.3.2Town/ cityMartinsried/Munich
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number0049089309050680
    B.5.5Fax number00490893090506868
    B.5.6E-mailinfo@suppremol.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/462
    D.3 Description of the IMP
    D.3.1Product namesoluble Fc-gamma receptor IIb
    D.3.2Product code SM101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN.
    D.3.9.1CAS number .
    D.3.9.2Current sponsor codeSM101
    D.3.9.3Other descriptive namesoluble Fc receptor
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Auto-immune disease
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy and pharmacokinetics (PK) of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria 1.Patient has provided written informed consent prior to any study-related procedure 2.Male or female adult patients aged 18 years or older 3.Patients with a body weight between ≥ 40 kg and ≤ 100 kg 4.At least 4 criteria of the American College of Rheumatology (ACR) revised criteria (APPENDIX 1) documented in the medical history 5.A SELENA-SLEDAI score of at least 6 within 8 weeks prior to the first IP dosing. A subpopulation will fulfil in addition the following criteria for lupus nephritis: a) A history of class III, IV, or a combination of these with class V glomerulonephritis, within 60 months prior to first IP dosing confirmed by a renal biopsy according to the International Society of Nephrology (ISN) and the Renal Pathology Society (RPS) [APPENDIX 2]. The patient had never a pure class V or VI glomerulonephritis during the disease course AND b) Proteinuria between > 0.2 to ≤ 3.5 g/day at SCR 6.Patients with a present serological active status defined as abnormal laboratory values from the last 2 local serum samples for the following parameters: a) serum antibodies against double-stranded DNA (anti-dsDNA) above upper limit of normal (ULN) OR/AND b) complement component 3 (C3) below lower limit of normal (LLN) Abnormality will be confirmed by a central laboratory during screening. 7.Patients with immunosuppressant SLE treatment (if any) other than listed under 8. have completed their SLE therapy prior to first IP dosing as follows: a) B-cell depleting agents (e.g. rituximab, epratuzumab, etc.) for ≥ 48 weeks b) B-cell modifying agents (e.g. belimumab, atacicept, etc.) for ≥ 24 weeks c) Intravenous immunoglobulins (IVIGs) for ≥ 12 weeks d) All other immunosuppressive SLE treatment (e.g. metho-trexate, cyclophosphamide, cyclosporine, tacrolimus, etc.) for ≥ 8 weeks 8.Patients with a stable maintenance immunosuppressant SLE treatment (if any) within 4 weeks prior to first IP dosing consisting of: ≤ 20 mg/day prednisone (or equivalent) alone or in combination with either a) ≤ 2 mg/kg/day azathioprine (AZA) OR b) ≤ 2 g/day mycophenolate mofetil (MMF) [or equivalent] 9.The maintenance immunosuppressant SLE treatment is intended to remain stable during the clinical trial but at least within 4 weeks after the first IP dosing 10.Patients with a stable adjuvant maintenance SLE treatment (if any) such as antimalarias, angotensin-converting enzyme (ACE) inhibitors, non-steroid anti-inflammatory drugs (NSAIDs), cyclooxygenase inhibitors, anticoagulation- and antiplatelet agents, hormone replacement therapy, etc. within 4 weeks prior to first IP dosing. The adjuvant maintenance SLE treatment is intended to remain stable during the clinical trial but at least within 4 weeks after first IP dosing 11.Women of childbearing potential must have a negative serum pregnancy test within 3 weeks preceding the first dose of IP and a negative urine pregnancy test on study day 1 12.Both women of childbearing potential and men must use a medically acceptable method of contraception (APPENDIX 7) prior to inclusion, throughout the study, and within 12 weeks after IP discontinuation 13.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with a life expectancy of at least 9 months (APPENDIX 8)
    E.4Principal exclusion criteria
    Exclusion 1.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period 2.Patients with active SLE neurological disorder documented according to the ACR SLE criteria as listed in APPENDIX 1 within 12 weeks prior to first IP dosing 3.Patients with non-lupus related renal diseases or microthrombotic disease associated with antiphospolipid syndrome 4.Patients with known active retroviral infection such as as human immunodeficiency virus (HIV), hepatitis B or C 5.Patients with other acute infections (except minor infections such as common cold) within 4 weeks prior to first IP dosing 6.Patients with a glomerular filtration rate (GFR) of < 45 mL/min/1.73 m2 7.Patients with inadequate liver function expressed as at least one of the following: a) Aspartate aminotransferase (AST) > 3 times ULN OR b) Alanine aminotransferase (ALT) > 3 times ULN OR c) Serum bilirubin > 3 times ULN 8.Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with all study procedures 9.Known hypersensitivity to any recombinant E. coli-derived product or IP excipients (Polysorbat 20, Mannitol, Sucrose) 10.Patients participating in a concurrent clinical trial or treated with another IP within 4 weeks or five terminal half-lives (whichever is longer) prior to first IP dosing 11.History of alcohol or drug abuse within the previous 5 years 12.Any condition which in the judgment of the Investigator would place the patient at undue risk or interfere with the results of the study 13.Patients with an active malignancy 14.Patients with active, serious, life-threatening diseases
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events (AEs) during the study period according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over a 24 week period
    E.5.2Secondary end point(s)
    Efficacy Kidney parameters •Change in proportion of patients with proteinuria (urine protein > 0.2, > 0.5, > 1.0 and > 2.0 g/day) from screening (SCR) to end of week 4, 12 and 24 •Percent change of urine protein from SCR to end of week 4, 12 and 24 •Percent change of glomerular filtration rate (GFR) from SCR to end of week 4, 12 and 24 •Change in proportion of patients with active urine sediment defined as ≥ 5 white blood cell (WBC) count/high power field (HPF) or ≥ 5 red blood cell (RBC) count/HPF or ≥ 1 cellular cast from SCR to end of week 4, 12 and 24 •Percent change of urinary neutrophil gelatinase-associated lipocalin (uNGAL) from SCR to end of week 4, 12 and 24 •Proportion of patients with a complete or partial renal SLE response according to the Renal Response Index (RRI) from SCR to end of week 4, 12 and 24 •Incidence of end-stage renal disease (ESRD) requiring dialysis or renal transplantation from SCR to end of week 24 Serology parameters •Percent change of anti-double-stranded DNA-antibodies (anti-dsDNA), anti-complement-component C1q-antibodies (anti-C1q), C3 and C4 concentration from SCR to end of week 4, 12 and 24 •Proportion of patients with a serological SLE response, defined as: a) ≥ 25% increase of C3 level and b) ≥ 25% decrease in anti-dsDNA concentration from SCR at end of week 4, 12 and 24 Numerical scoring parameters •Renal activity score according to RRI from SCR to end of week 4, 12 and 24 •Absolute change of the Safety of Estrogen in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from SCR to end of week 4, 12 and 24 (refer to APPENDIX 3 for the SLEDAI form) •Absolute change of British Isles Lupus Assessment Group (BILAG) score from SCR to end of week 4, 12 and 24 •Absolute change of the Physician Global Assessment (PGA) score from SCR to end of week 4, 12 and 24 •Proportion of patients with a clinical SLE response (defined as reduction of at least 4, 5, 6 or 7 points in the SELENA-SLEDAI score from SCR) at end of week 4, 12 and 24 •Proportion of patients with flared defined as ≥ 1 new BILAG A score or ≥ 2 new BILAG B score from SCR to end of week 24 •Time to flare defined as ≥ 1 new BILAG A score or ≥ 2 new BILAG B scores from SCR to end of week 24 •Proportion of patients with no worsening (< 0.3 point increase from SCR) in the PGA score to end of week 24 Treatment parameters •Proportion of patients requiring rescue medication, defined as increase in concomitant immunosuppression or new immunosuppressant therapy including corticosteroids from day 1 to end of week 24 •Total number of rescue medication intake from day 1 to end of week 24 •Cumulative dose of overall immunosuppressive SLE treatment including corticosteroids from day 1 to end of week 24 •Proportion of patients with dose reduction of overall immunosuppressive SLE treatment including corticosteroids from day 1 to end of week 24 Other •Number of unscheduled hospital days from day 1 to end of week 24 •IP PK parameters at end of week 1 and 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint(s) of evaluation of this end point From baseline to end of week 4, 12 and 24 except; Incidence of end-stage renal disease (ESRD) requiring dialysis or renal transplantation from baseline to end of week 24 Proportion of patients with flares defined as 1 new BILAG A score or 2 new BILAG B scores from baseline to end of week 24 Time to flare defined as 1 new BILAG A score or 2 new BILAG B scores from baseline to end of week 24 Proportion of patients with no worsening (< 0.3 point increase from baseline) in the PGA score to end of week 24 Treatment parameters from baseline to end of week 24 Number of unscheduled hospital days from baseline to end of week 24 Investigational product PK parameters at end of week 1 and 4
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 50
    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)
    Normal standard of routine clinical care
    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 Decision2012-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-16
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