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    Summary
    EudraCT Number:2006-007057-42
    Sponsor's Protocol Code Number:A4M108119
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-007057-42
    A.3Full title of the trial
    An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast
    A.4.1Sponsor's protocol code numberA4M108119
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 namefirategrast (USAN approved name)
    D.3.2Product code SB-683699
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 402567-16-2
    D.3.9.2Current sponsor codeSB-683699
    D.3.9.3Other descriptive namefirategrast (USAN approved name)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsing forms of multiple sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive 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 aims of this study are 1) to determine, for a sample of subjects with relapsing forms of MS, the number and change from baseline in the number of leukocytes and the CD4:CD8 ratio in the CSF and blood up to the completion of 24-weeks of dosing with firategrast and 2) to assess the number and change from the end of treatment (and baseline) in the number of leukocytes and the CD4:CD8 ratio in the CSF and blood in the 12-week period following treatment with firategrast. These objectives will be assessed through the use of descriptive statistics only.
    E.2.2Secondary objectives of the trial
    • To determine the number and change in number of total leukocytes, total lymphocytes and lymphocyte subsets and the CD4:CD8 ratio in the CSF and blood during and after treatment with firategrast.
    Lymphocyte subsets:
    T-lymphocytes: CD4+, CD8+
    B-lymphocytes: CD19+
    • To examine blood for mobilization of CD34+ early hematopoietic progenitor cells from the bone marrow during and after treatment with firategrast.
    • To explore the relationship between changes in the number of leukocytes in the CSF and blood.
    • To explore the relationship between systemic exposure to firategrast and the metabolite, GW786375X, and changes in leukocyte counts in the CSF and blood.
    • To determine firategrast and GW786375X levels in CSF.
    • To explore potential relationships between genetic variants and response to firategrast, pharmacokinetic endpoints and bilirubin levels.
    • To investigate the safety and tolerability of up to six months' administration of firategrast.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    2. Male or female, age 18 to 65.
    3. A diagnosis of a relapsing form of MS [As per McDonald, 2001; Polman, 2005], with dissemination in time and space.
    4. Expanded Disability Status Scale (EDSS) score of between 0 and 6.5 inclusive.
    5. Occurrence of at least one clinical attack in the previous 24 months, but not within the 4 weeks prior to Screening or prior to the Baseline Visit.
    6. A minimum of two T2 lesions on brain MRI at Screening, as determined by the central MRI analysis reader.
    7. A female subject is eligible to enter the study if she is:
    a. Of non-childbearing potential OR
    b. Of childbearing potential, has a negative urine pregnancy test at Screening and Baseline, and agrees to consistent and correct use the method of contraception as per the protocol
    E.4Principal exclusion criteria
    1. Subjects receiving corticosteroids within 4 weeks of Screening for treatment of MS.
    2. Use of a beta-interferon product, glatiramer acetate or azathioprine within 3 months of Screening, or use of Mitoxantrone within 12 months of Screening.
    3. Previous exposure to alemtuzumab, natalizumab or firategrast administration, bone marrow transplantation or whole body irradiation.
    4. Subjects with a cardiac pacemaker or any other type of metal implant or with any other contraindication for MRI.
    5. Use of 4-aminopyridine, rosiglitazone, pioglitazone or any drug that is an inhibitor of or a substrate (with a low therapeutic index) for Organic Anion Transporter Protein (OATP).
    6. Subjects with clinically significant renal laboratory values: subjects with a calculated creatinine clearance <60ml/min (by Cockcroft and Gault) at Screening.
    7. Subjects with local urinalysis findings of 1) proteinuria, defined as greater than or equal to 1+ protein on urine dipstick or 2) renal tubular cell casts or 3) greater than or equal to 5 red blood cells / high power field will be excluded from the study if the result is still present on a repeat urinalysis during the Screening Phase.
    8. Presence of clinically significant hepatic laboratory values: ALT, AST, GGT > 2 times the upper limit of the reference range; total bilirubin > 1.5 the upper limit of the normal range.
    9. CD4 count < 500, CD4:CD8 < 1.0, JCV viremia in plasma or white cells, idiopathic CD4/CD8 lymphopenia or secondary lymphopenia at Screening.
    10. Any findings at Screening on the MRI of the brain other than MS, except for benign findings.
    11. Uncontrolled or any active bacterial, viral, or fungal infection.
    12. History of tuberculosis (TB) or positive chest X-ray for TB at Screening.
    13. Known congenital or acquired immunodeficiency.
    14. Current or history of cancer, excluding localized non-melanoma skin cancer.
    15. Any abnormality on 12-lead Electrocardiogram (ECG) at Screening.
    16. Positive hepatitis B surface antigen, hepatitis C antibody or HIV tests at Screening.
    21. Contraindications to lumbar puncture.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures are the number and change in number of total leukocytes, total lymphocytes and lymphocyte subsets (CD4+ and CD8+ T-lymphocytes, CD19+ B-lymphocytes, CD34+ early hematopoietic progenitor cells) and the CD4:CD8 ratio in the CSF and/or blood. The time points of interest for all of the above endpoints are Baseline, Treatment Week 4 (CD34+ early hematopoietic progenitor cells in blood only), Treatment Week 24 (End-of-Treatment) and Core Follow-up Weeks 28 and 36.
    Safety and tolerability will be monitored through regular assessment of vital signs, clinical laboratory data, adverse events (AEs), clinical examination (including relapse and Expanded Disability Status Scale (EDSS) score), Magnetic Resonance Imaging (MRI) analysis for MS progression (gadolinium-enhancing lesions) and for PML and presence of JC virus in plasma and buffy coat. This study and study A4M105038 (Phase 2 efficacy study) will be conducted under the auspices of an Independent Data Monitoring Committee (IDMC), and safety data from this study will be reviewed by the IDMC on an ongoing basis.
    Plasma and CSF levels of firategrast will be measured at selected visits.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    exploratory
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Following the treatment phase (24 weeks) subjects will enter the 12 week core-follow up phase, followed by a 40 week extended follow-up phase for safety reasons which will consist of a telephone call and final clinical visit.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 45
    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)
    As stated in the protocol subject completing the treatment phase will enter core and extended follow-up phases
    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 Decision2007-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
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