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    Summary
    EudraCT Number:2020-001537-13
    Sponsor's Protocol Code Number:ALXN1210-NEPH-202
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-29
    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 number2020-001537-13
    A.3Full title of the trial
    A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
    A.3.2Name or abbreviated title of the trial where available
    Ravulizumab in LN or IgAN
    A.4.1Sponsor's protocol code numberALXN1210-NEPH-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04564339
    A.5.4Other Identifiers
    Name:INDNumber:148192
    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 SponsorAlexion Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportAlexion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103-105 rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number33789973326
    B.5.6E-mailclinicaltrials.eu@alexion.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRavulizumab
    D.3.2Product code ALXN1210
    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 INNRAVULIZUMAB
    D.3.9.1CAS number 1803171-55-2
    D.3.9.2Current sponsor codeALXN1210
    D.3.9.3Other descriptive nameBNJ441
    D.3.9.4EV Substance CodeSUB192773
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Lupus Nephritis (LN)
    Immunoglobulin A Nephropathy (IgAN)
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis (LN)
    Immunoglobulin A Nephropathy (IgAN)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ravulizumab compared with placebo to reduceproteinuria in adult participants with LN or IgAN
    E.2.2Secondary objectives of the trial
    Safety and tolerability of ravulizumab and additional efficacy measures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Common to both disease cohorts:
    - 18 - 75 years of age
    - Proteinuria ≥ 1 (g/d or g/g)
    - Vaccinated against meningococcal infection
    - Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae

    For LN cohort:
    - Diagnosis of active focal or diffuse proliferative LN Class III or IV
    - Clinical active LN, requiring/receiving immunosuppression induction treatment

    For IgAN cohort:
    - Diagnosis of primary IgAN
    - Compliance with stable and optimal dose of RAS inhibitor treatment for ≥ 3 months
    - For participants with a kidney biopsy used for eligibility > 1 year prior to Screening : Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥ 10 red blood cell (RBC)/hpf microscopy on urine sediment (as documented by the local laboratory). Presence of hematuria documented by the central laboratory may also be acceptable.Participants with established intolerance to RAS inhibitors may be included

    For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1.
    E.4Principal exclusion criteria
    Common to both disease cohorts:
    - Estimated GFR < 30 mL/min/1.73 m2
    - For patients with eGFR < 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior orduring the Screening Period:
    ≥ 50% interstitial fibrosis and tubular atrophy
    ≥ 50% glomerular sclerosis,
    ≥ 50% active crescent formation
    - Previously received a complement inhibitor (eg, eculizumab) at any time
    - Concomitant significant renal disease other than LN or IgAN
    - History of other solid organ or bone marrow transplant
    - Uncontrolled hypertension
    - Institutionalization by administrative or court order or known medical or psychological condition or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study
    - Known history of human immunodeficiency virus (HIV) infection
    - Hypersensitivity to any ingredient contained in the study drug

    For LN cohort:
    -Participants who have initiated any of the following treatments for the current active LN flare :
    a. Cyclophosphamide ≤ 6 months prior to Screening
    b. Calcineurin inhibitors ≤ 3 months prior to Screening
    c. A cumulative dose of IV methylprednisolone > 3 g
    d. Mycophenolate mofetil > 2 g/day (or equivalent) for ≥ 4 consecutive weeks prior to Screening
    e. Oral corticosteroids ≥ 0.5 mg/kg/day for ≥ 4 consecutive weeks prior to Screening

    For IgAN cohort:
    - Diagnosis of rapid progressive glomerulonephritis
    - Prednisone or prednisone equivalent > 20 mg/day for > 14 consecutive days or any other immunosuppression within 6 months for the treatment of IgAN ≤ 6 months prior to Screening
    - Body mass index ≥ 38 kg/m2

    For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change in proteinuria
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 26
    E.5.2Secondary end point(s)
    Common to both disease cohorts:
    - Percentage change in proteinuria
    - Change from baseline in eGFR

    For LN:
    - Percentage of participants meeting the criteria for Complete Renal Response
    - Percentage of participants meeting the criteria for Partial Renal Response
    - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g
    - Percentage of participants achieving corticosteroid taper to 7.5 mg/day
    - Percentage of participants with Renal Flare
    - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare
    - Percentage of participants with Suboptimal Response through Week 50

    For IgAN:
    - Percentage of participants meeting the criteria for Partial Remission
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout, Week 26 and/or Week 50
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Singapore
    Taiwan
    Australia
    Canada
    Korea, Republic of
    United Kingdom
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days3
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 120
    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)
    Ravulizumab will not be administered to participants after the end of the study. Upon completion of the last study visit, participants will return to the care of their treating physician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NephroSynergy CRO, LLC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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