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    Summary
    EudraCT Number:2007-003925-26
    Sponsor's Protocol Code Number:28156
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-07
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2007-003925-26
    A.3Full title of the trial
    A two-arm, randomised, double-blind, placebo-controlled, multicenter phase II study to evaluate safety and tolerability and to explore the neuroprotective effect of atacicept as assessed by Optical Coherence Tomography (OCT) in subjects with Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) over a 36 week treatment course
    A.3.2Name or abbreviated title of the trial where available
    Atacicept in Optic Neuritis, Phase II
    A.4.1Sponsor's protocol code number28156
    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.3.2Product code TACI-Fc5
    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 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
    Optic Neuritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10030942
    E.1.2Term Optic neuritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of atacicept to preserve Retinal Nerve Fiber Layer (RNFL) thickness in Optic Neuritis (ON) as assessed by Optical Coherence Tomography (OCT).
    E.2.2Secondary objectives of the trial
    - Evaluate safety and tolerability of atacicept in subjects with ON including the incidence and severity of infections and the conversion of subjects with ON to RMS as per McDonald criteria or to Clinically Definite MS (CDMS).
    - Explore the effect of atacicept on visual outcomes such as low contrast letter acuity and contrast sensitivity in subjects with ON.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days of SD1;
    2. Male or female between 18-60 years old, inclusive, at the time that informed consent is obtained;
    3. Written informed consent, given before any study-related procedure. Subjects must have read and understood the Informed Consent Form, must fully understand the requirements of the study and must be willing to comply with all study visits and assessments.
    4. Women of childbearing potential must not be breast feeding and have a negative serum pregnancy test at initial screening and a urine pregnancy test at Study Day 1 before dosing. For the purpose of this study, women of childbearing potential are defined as all female patients after puberty unless they are post-menopausal for at least 2 years or surgically sterile.
    5. Female subjects of childbearing potential must be willing to avoid pregnancy by using adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 12 weeks after the last dose of study medication. This requirement does not apply to surgically sterile subjects or to subjects who are post-menopausal for at least 2 years. Adequate contraception is defined as follows: two barrier methods, or one barrier method with a spermicide, or an intrauterine device or use of a combined female hormonal contraceptive.
    6. Be willing and able to comply with study procedures for the duration of the study;
    7. 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. History of ON prior to current ON attack;
    2. Bilateral optic neuritis;
    3. Diagnosis of MS;
    4. Diagnosis of Devic’s disease;
    5. Acute or history of co-morbid ocular condition of the affected or non-affected eye not related to optic neuritis (ascertained by detailed history and examination, including glaucoma, hypoplasia of the optic nerve, macular hole, vitreomacular traction, diabetes, or other diseases of the optic nerve) or other causes of inflammatory optic neuropathy including but not limited to sarcoidosis, systemic lupus and other vasculitides, paraneoplastic disease, syphilis, Lyme disease, infection, ischemic optic neuropathy, Leber´s hereditary optic neuropathy;
    6. Non-evaluable OCT at screening visit due to edema in the affected eye defined as follows:RNFL thickness more than 10 micrometer above normal in 2 or more sectors, or RNFL thickness greater than 200 micrometer in any of the 12 sectors;
    7. Refractive error greater than ± 6 diopters (including status prior to refractive surgery);
    8. Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments (such as, but not limited to, significant nervous system, renal, hepatic, endocrine or gastrointestinal disorders), which in the Investigator’s opinion constitutes a risk or a contraindication for the subject’s participation in the study or that could interfere with the study objectives, conduct or evaluation.
    9. Prior treatment with B cell modulating therapies, such as rituximab or belimumab;
    10. Prior exposure to immunomodulatory therapy, such as interferon beta or glatiramer acetate;
    11. Prior exposure to immunosuppressive or cytotoxic agents including but not restricted to cladribine, mitoxantrone, alemtuzumab, cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, or natalizumab;
    12. Prior myelosuppressive / cytotoxic therapy, such as lymphoid irradiation, or bone marrow transplantation;
    13. Prior use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIg) or plasmapheresis;
    14. Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 60 days prior to SD1 except the optional corticosteroid course to treat the initial ON event;
    15. Require chronic or monthly pulse corticosteroids during the study;
    16. Receive immunisations with live vaccines or Ig treatments within one month prior SD 1 or need for such treatment during the study;
    17. Participation in any interventional clinical trial within 2 months before SD 1 (or within 5 half-lives of the investigated compound before SD 1, whichever is longer), prior to SD1
    18. Have moderate to severe renal impairment (creatinine clearance < 50 ml/min; according to Cockcroft-Gault equation);
    19. Allergy or hypersensitivity to gadolinium;
    20. Known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
    21. Diagnosis or family history of Creutzfeldt-Jakob disease (CJD)
    22. History or presence of uncontrolled or New York Health Association (NYHA) class 3 or 4 congestive heart failure;
    23. History of cancer, except adequately treated basal cell carcinoma of the skin, cervical dysplasia or carcinoma in situ of the skin or the cervix;
    24. Aspartate aminotransferase (AST) alanine aminotransferase (ALT) or alkaline phosphatase (AP) level >2.5 x ULN. Total bilirubin >1.5 x ULN at screening;
    25. Clinically significant abnormality in any haematological test (e.g. haemoglobin < 100 g/L (6,21 mmol/L), WBC < 3*109/L, lymphocyte count <0.8*109/L, platelets <140*109/L) at screening;
    26. Clinically significant abnormality on chest X-ray performed within 3 months before SD1 or on ECG performed at screening;
    27. 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 assessments;
    28. Positive HIV, hepatitis C or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening);
    29. 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.
    30. Serum IgG below 6 g/L at screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change of RNFL thickness in the affected eye of ON patients from Baseline to week 36, assessed by OCT.
    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 No
    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 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 EEA20
    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 years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 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.1.3Elderly (>=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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 34
    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)
    None
    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 Decision2008-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-30
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