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    Summary
    EudraCT Number:2011-004475-36
    Sponsor's Protocol Code Number:DC-002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-10
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-004475-36
    A.3Full title of the trial
    A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis
    A.4.1Sponsor's protocol code numberDC-002
    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 SponsorDelta Crystallon B.V.
    B.1.3.4CountryNetherlands
    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 supportDelta Crystallon B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI
    B.5.2Functional name of contact pointRegulatory department
    B.5.3 Address:
    B.5.3.1Street Address65 Buntovnik Str., Lozenetz Region
    B.5.3.2Town/ citySofia
    B.5.3.3Post code1421
    B.5.3.4CountryBulgaria
    B.5.4Telephone number+35928162400
    B.5.5Fax number+35928162401
    B.5.6E-mailRASofia@psi-cro.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 nameDC-TAB
    D.3.2Product code DC-TAB
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor coderecombinant human CRYAB
    D.3.9.3Other descriptive namerecombinant human alpha B-crystallin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 placeboSolution for injection
    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
    Relapsing multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    Relapsing multiple sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 safety and tolerability of three single doses of DC-TAB administered intravenously with 2-months intervals in patients with multiple sclerosis.
    E.2.2Secondary objectives of the trial
    1. To evaluate the antigen-specific T-cell tolerance inducting effect of three single doses of DC-TAB administered intravenously with 2-months intervals in patients with multiple sclerosis.
    2. To evaluate the clinical effects of three single doses of DC-TAB with 2-months intervals administered intravenously in patients with multiple sclerosis.
    3. To evaluate the pharmacokinetics of DC-TAB in patients with multiple sclerosis.
    4. To evaluate the effects of three single doses of DC-TAB with 2-month intervals administered intravenously to patients with multiple sclerosis on serum levels of CRYAB/DC-TAB-reactive antibodies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria:
    • Clinically definite, relapsing multiple sclerosis, according to the McDonald criteria, and abnormal MRI scan consistent with MS
    • Neurologically stable
    • At least one clinical relapse over the previous year, or two relapses over the past two years, or one or more gadolinium-enhancing MRI lesion(s) at the time of screening.
    • An EDSS score smaller than or equal to 5.5
    • Age 18-55 years
    E.4Principal exclusion criteria
    1. Primary progressive multiple sclerosis
    2. Use of systemic corticosteroid treatment for more than 3 days within 30 days prior to screening
    3. Plasmapheresis, or intravenous gammaglobulins less than 2 months before screening
    4. Treatment with natalizumab less than one year before screening
    5. Previous immunosuppressive treatment (e.g. cyclophosphamide or mitoxantrone)
    6. Previous treatment with any leukocyte-targeting monoclonal antibody (e.g. rituximab, alemtuzumab, daclizumab)
    7. Previous treatment with oral immune-modulatory agents (cladribine, fingolimod, laquinimod, fumarate)
    8. Pregnant women, women planning to become pregnant and breastfeeding women
    9. A history of or currently active clinically significant cardiac (including clinically significant ECG abnormalities in the opinion of the PI), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
    10. ALT, AST and/or gamma-GT above 3 times the upper limit of normal
    11. Serum creatinine above 1.5 times the upper limit of normal or an eGFR < 60 ml/min/1.73 m2
    12. Hemoglobin < 7.0 mmol/l for females and < 8 mmol/l for males; leucocytes > 20*109/l or < 3.5*109/l; platelets < 125*109/l
    13. SBP > 160 mmHg and/or DBP > 100 mmHg
    14. Acute respiratory or other active infections
    15. Fever (body temperature > 38.0 °C on day 1
    16. Blood donation or significant blood loss within 90 days of first study medication dosing
    17. Plasma donation within 7 days of first study medication dosing
    18. Recipients of blood or blood products in the last 6 months
    19. Participation in another clinical study within 90 days of the start of this trial or planning participation in another clinical trial during this study or in the 4 weeks after last visit
    20. Taking anti-coagulation or anti-platelet medication with the exception of NSAID’s.
    21. History of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake more than 28 units of alcohol), or psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
    22. Vaccination with any vaccine within 4 weeks prior to dosing of the study medication
    23. History of serious adverse reactions or hypersensitivity to any medicinal product
    24. History of a malignancy other than skin cell basalioma 5 years prior to screening
    25. Any physical condition that would, in the opinion of the investigator, place the patient at an unacceptable health risk or risk of injury or render the patient unable to meet the requirements of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters
    • Number and frequency of adverse events including local irritability complaints
    • ECG parameters
    • Clinical chemistry and hematology parameters
    • Urinalysis
    • Vital signs and body temperature
    • MRI signs and symptoms
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 and 12 months
    E.5.2Secondary end point(s)
    Effect endpoints
    • T-cell responses (CD4+ and CD45RO+) to DC-TAB throughout the 48-week study
    • Cumulative number of new or enlarging gadolinium-enhancing MRI lesions between weeks 4 and 24 and between weeks 4 and 48 after treatment, relative to baseline
    • The number of clinical relapses between week 0 and week 24, and week 0 and week 48
    • Change in EDSS score between week 0 and week 24, and week 0 and week 48
    • Change in MSIS-29 score between week 0 and week 24, and week 0 and week 48
    • Level of CRYAB/DC-TAB-reactive serum antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 and 12 months
    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 No
    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
    The effects of the treatment on the development of MRI lesions, on T-cell tolerance, and on levels of CRYAB/DC-TAB-reactive serum antibodies will be explored.
    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 trial4
    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 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 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
    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 months9
    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 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.1.2.1Number of subjects for this age range: 32
    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 No
    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 state32
    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 Decision2012-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-18
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