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    Summary
    EudraCT Number:2007-003936-50
    Sponsor's Protocol Code Number:28063
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-10
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2007-003936-50
    A.3Full title of the trial
    A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.
    A.3.2Name or abbreviated title of the trial where available
    Atacicept frequent MRI study in RMS
    A.4.1Sponsor's protocol code number28063
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Serono S.A. - Geneva
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameatacicept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNatacicept
    D.3.9.3Other descriptive nameTACI-Fc5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNatacicept
    D.3.9.3Other descriptive nameTACI-Fc5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNatacicept
    D.3.9.3Other descriptive nameTACI-Fc5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSolution for injection
    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
    Relapsing multiple sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.
    E.2.2Secondary objectives of the trial
    - Evaluate safety and tolerability of three doses of atacicept in subjects with RMS, including incidence and severity of infections.
    - Evaluate three doses of atacicept in order to determine a minimally effective dose (MED) in subjects with RMS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Relapsing Multiple Sclerosis (per McDonald criteria, 2005);
    2. Fulfil at least one of the following: two or more documented relapses during the previous 2 years, one or more documented relapses in the year before enrolment, or one or more Gd- enhancing lesions detected on MRI at screening.
    3. Male or female between 18-60 years old, inclusive at the time the informed consent is obtained.
    4. Have an EDSS from 0 5.5, inclusive;
    5. Women of childbearing potential must not be breast feeding and have a negative serum/urine pregnancy test at initial screening and at Study Day 1 (SD1) before dosing. For the purposes of this trial, a woman of childbearing potential is defined as: “All female subjects after puberty unless they are post-menopausal for at least two years, or are surgically sterile”.
    6. Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for approximately four (4) weeks prior to SD1, during and for twelve (12) weeks after the last dose of trial medication. This requirement does not apply to surgically sterile subjects or to subjects who are postmenopausal for at least 2 years. Adequate contraception is defined as two barrier methods, or one barrier method with spermicide, or intrauterine device or use of the oral female contraceptive;
    7. Subject is willing and able to comply with study procedures for the duration of the study;
    8. Voluntarily provide written informed consent (obtained before any trial related procedure), including, for USA, subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, and with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care.
    E.4Principal exclusion criteria
    1. Have primary progressive MS.
    2. Have secondary progressive MS without superimposed relapses.
    3. Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator, constitute a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
    4. Prior treatment with B cell modulating therapies, such as rituximab or belimumab.
    5. Exposure to immunomodulatory therapy, such as interferon beta or glatiramer acetate, within 3 months prior to SD1.
    6. Discontinuation of prior immunodulatory therapy due to perceived lack of efficacy.
    7. Prior exposure to immunosuppressive or cytotoxic agents including but not restricted to cladribine, mitoxantrone, alemtuzumab cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, or natalizumab.
    8. Prior myelosuppressive / cytotoxic therapy, such as lymphoid irradiation, or bone marrow transplantation.
    9. Prior use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIg) or plasmapheresis within 6 months prior to SD1.
    10. Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to SD1.
    11. Require chronic or monthly pulse corticosteroids during the study
    12. Participation in any interventional clinical trial within 2 months prior to SD1, or within 5 half-lives of the investigated compound, whichever is longer.
    13. Allergy or hypersensitivity to atacicept or to any of the components of the formulated atacicept.
    14. Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).
    15. Moderate to severe renal impairment (creatinine clearance <50ml/min according to Cockcroft-Gault equation).
    16. Allergy or hypersensitivity to gadolinium.
    17. History or presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive heart failure.
    18. History of cancer, except adequately treated basal cell carcinoma of the skin, cervical dysplasia or carcinoma in situ of the skin or the cervix.
    19. Aspartate aminotransferase (AST) alanine aminotransferase (ALT) or alkaline phosphatase (AP) level >2.5 x ULN. Total bilirubin >1.5 x ULN at screening.
    20. Clinically significant abnormality in any haematological test (e.g. haemoglobin <100 g/L (6,21 mmol/L), WBC <3*109/L, lymphocytes <0.8*109/L, platelets <140*109/L) at screening.
    21. Clinically significant abnormality on chest X-ray performed within 3 months prior to SD1 or on ECG performed at screening.
    22. Immunisation with live vaccines within one month prior to SD1 or need for such treatment during the study.
    23. Known active clinically significant acute or chronic infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of SD1
    24. Positive HIV, hepatitis C or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
    25. Presence of active or latent tuberculosis within the past year prior to screening. Subjects should be evaluated and screened for active or latent tuberculosis according to national and/or local recommendations
    26. Serum IgG below 6 g/L at screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean number of T1 gadolinium (Gd)-enhancing lesions per subject per scan from week 12 to 36, inclusive.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The date of the final clinical database lock
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.3Elderly (>=65 years) No
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 255
    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)
    This study will be followed by an open label extension study which is currently being planned, unless the DMC recommends otherwise.
    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 Decision2008-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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