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    The EU Clinical Trials Register currently displays   31826   clinical trials with a EudraCT protocol, of which   5135   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-005606-30
    Sponsor's Protocol Code Number:CAM-THY
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-04-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005606-30
    A.3Full title of the trial
    Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).
    A.3.2Name or abbreviated title of the trial where available
    CAM-THY
    A.4.1Sponsor's protocol code numberCAM-THY
    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 SponsorCambridge University Hospitals NHS Foundation Trust and University of Cambridge
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical Research Council (MRC)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportMoulton Charitable Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCambridge University Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointMrs Carrie Bayliss
    B.5.3 Address:
    B.5.3.1Street AddressCambridge Clinical Trials Unit, Box 111, Addenbrookes Hospital
    B.5.3.2Town/ cityHills Road, Cambridge
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01223348158
    B.5.5Fax number01223596471
    B.5.6E-mailcarrie.bayliss@addenbrookes.nhs.uk
    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 Yes
    D.2.1.1.1Trade name Kepivance
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB (publ) SOBI
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameKepivance
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNPalifermin
    D.3.9.1CAS number 162394-19-6
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name MabCampath
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAlemtuzumab
    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 INNAlemtuzumab
    D.3.9.1CAS number 216503-57-0
    D.3.9.3Other descriptive nameanti-CD52 monoclonal antibody
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Yes
    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
    This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS) patients who may develop new diseases due to an over-active immune system as a result of treatment with alemtuzumab
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10058948
    E.1.2Term Nephritis autoimmune
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10049046
    E.1.2Term Autoimmune thyroiditis
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061664
    E.1.2Term Autoimmune disorder
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068004
    E.1.2Term Autoimmune hyperthyroidism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10050245
    E.1.2Term Autoimmune thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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
    The primary objective of this trial is to determine if Kepivance can prevent patients with multiple sclerosis from developing new autoimmune diseases after treatment with alemtuzumab.
    E.2.2Secondary objectives of the trial
    Our secondary objective is to determine if Kepivance can boost the function of the thymus in adult humans. The thymus is a gland that sits in the neck. Its function is to make new immune cells. If Kepivance can boost the function of the thymus gland this has important implications for a number of patient groups - for example patients who have reduced numbers of immune cells due to HIV infection, or because of treatment with chemotherapy drugs.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The dose escalation sub-study is included as part of the main study protocol and submission, therefore the title, date and version remain the same as the main study. The objective of the sub-study is to identify the maximum tolerated dose of Kepivance in patients with Multiple Sclerosis, receiving treatment with Alemtuzumab. The dose identified as part of this sub-study will be used in the main study to treat a further 37 patients (37 Kepivance patients plus the 3 patients treated at the maximum tolerated dose in the sub-study)
    E.3Principal inclusion criteria
    To be included in the trial the patient must have/be: • Male or non-pregnant, non-lactating female patients • Aged between 18 and 50 years inclusive • Diagnosis of MS using McDonald’s criteria, including diagnostic MRI • Onset of first MS symptoms within 10 years • EDSS score 0.0 to 5.0 (inclusive) at screening • At least 2 clinical episodes of MS in the 2 years prior to study entry, with at least 1 attack within 12 months, which may have occurred whilst on disease-modifying therapy, such as beta interferon therapy or glatiramer acetate. • Serum IL-21 ≥230pg/mL. Apart from the IL-21 inclusion criterion, the details of patient selection are identical to those adopted in the phase 3 trials of alemtuzumab (CARE MS1 and MS2). This ensures that the results of this trial can be generalised to these patient groups.
    E.4Principal exclusion criteria
    The presence of any of the following will preclude patient inclusion: •Any progressive form of multiple sclerosis •Previous thymectomy •Previous treatment with alemtuzumab, mitoxantrone, cyclophosphomide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) •History of malignancy •Personal history of clinically significant autoimmune disease, other than multiple sclerosis (including but not limited to: thyroid disease, immune cytopenias, inflammatory bowel disease, diabetes, lupus, severe asthma) •Intolerance of pulsed corticosteroids, especially a history of steroid psychosis •Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results. •Seropositivity for human immunodeficiency virus (HIV) •Past or present hepatitis B infection (positive hepatitis B serology) •Pregnant women or male and female patients who do not agree to use effective contraception during the study. Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal based contraception, surgical sterilisation, abstinence, or double barrier contraception i.e. condom and occlusive cap (diaphragm or cervical cap with spermicide). • Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is incidence of clinical autoimmunity within 30 months of starting treatment with alemtuzumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be assessed for development of autoimmunity at all routine study visits - Months 1,3 6,9,12,13, 15,18,21,24,27,30. In addition patients will have monthly full blood counts to screen for the development of immune thrombocytopenia. The primary endpoint will be assessed once all patients have completed 30 months on study.
    E.5.2Secondary end point(s)
    • Percentage of naive T cells • Safety outcomes - incidence and nature of adverse events • Percentage of central memory T cells, effector memory T cells and T effector memory RA cells - as determined by flow cytometry • Frequency of recent thymic emigrants (defined by co-expression of CD45RA and CD31 in CD4+ T cells, and by CD45RA and CD103 in CD8+ T cells) - as determined by flow cytometry • T cell receptor (TCR) clonality - as determined by CDR3 spectratyping • Thymic function - as determined by measuring TRECs • Thymic volume and density - as assessed by non-contrast helical CT scans of the thymus performed at baseline, then again at 6 months following treatment. The scans will be analysed by a blinded thoracic radiologist who will perform a quantitative computer based analysis in order calculate thymic volume and density.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety assessment and recording of all adverse events will be performed throughout the study, and reviewed at all study visits- Months 1,3 6,9,12,13, 15,18,21,24,27, and 30. CT scans of the chest, to measure thymic volume and density, will be performed at baseline and month 6. Immunological assays of thymic function will be performed at baseline and again at months 1,3 6,9,12,13, 15,18,21,24,27, and 30.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    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 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 No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 86
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 state86
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 86
    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)
    On completion of the study, all patients will be referred back to their local NHS neurologist for routine management/care of their multiple sclerosis. Continued provision of alemtuzumab for this indictation, after this trial has ended, will depend upon decisions taken by the EMEA and NICE in 2012/3. We have no plans for continued provision of Kepivance.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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