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    Summary
    EudraCT Number:2004-000145-38
    Sponsor's Protocol Code Number:C0743T06
    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:2004-09-24
    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 number2004-000145-38
    A.3Full title of the trial
    A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis.
    A.4.1Sponsor's protocol code numberC0743T06
    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 SponsorCentocor 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 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 Information not present in EudraCT
    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 nameHuman monoclonal antibody (CNTO 1275) to interleukin-12p40
    D.3.2Product code CNTO 1275
    D.3.4Pharmaceutical form Powder for 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.3.9.2Current sponsor codeCNTO 1275
    D.3.9.3Other descriptive nameAnti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboPowder for solution 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
    Relapse-remitting Multiple Sclerosis (RRMS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10048393
    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 study is to assess the dose-response effect of multiple subcutaneous (SC) injections of CNTO 1275 in subjects with RRMS based on the cumulative number of new gadolinium (Gd)-enhancing T1-weighted lesions on cranial MRIs through week 23.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the clinical response and safety of multiple SC injections of CNTO 1275 and to describe the pharmacokinetics after repeated doses of CNTO 1275 in subjects with RRMS.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Be >/= 18 and </= 65 years of age at screening.
    2. Have a definite diagnosis of RRMS according to the 2001 Guidelines from the
    International Panel on the Diagnosis of MS (McDonald at al, 2001).
    3. Have a Kurtzke’s EDSS Scale score of 0 to 6.5 (described in Appendix B of the
    protocol).
    4. Have a history of at least 1 of the following:
    * A minimum of 2 relapses of MS within the previous 2 years but not within the
    1-month period prior to screening.
    * A relapse of MS within the previous 6 months but not within the 1-month period
    prior to screening.
    5. Women of childbearing potential and men must be using adequate birth control
    measures (eg, abstinence, oral contraceptives, intrauterine device [IUD], barrier
    method with spermicide, or surgical sterilization) during the study and must agree
    to continue such precautions for 1 year after receiving the last injection(s) of
    study agent. Women of childbearing potential must test negative for pregnancy at
    screening.
    6. Are considered eligible according to county–specific TB screening guidelines for
    latent TB defined in Section 4.3. of the protocol.
    7. Are capable of providing written informed consent, which must be obtained prior
    to any study-related procedures.
    8. Are able to adhere to the study visit schedule and understand and comply with
    other protocol requirements.
    E.4Principal exclusion criteria
    1. Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous) that could
    affect the interpretation of the functional disability scale scores.
    2. Have significant bulbar involvement of MS or other neurologic deficits or history
    that would, in the judgment of the investigator, place the subject at significant risk
    of infectious complications.
    3. Have a decubitus ulcer.
    4. Have an indwelling foley catheter.
    5. Have received any immunomodulating therapies (eg, interferon) within the
    3-month period prior to screening.
    6. Have received glatiramer acetate within the 3-month period prior to screening.
    7. Have ever received cladribine or any chemotherapeutic agents (eg, mitoxantrone).
    8. Have received systemic corticosteroids within the 1-month period prior to
    screening.
    9. Have received any previous treatment with CNTO 1275 or any other
    investigational agent for the treatment of MS that is known to target IL-12 or
    IL-23.
    10. Have received treatment in a clinical study within 3 months prior to screening or
    within 5 half-lives (if known) of an investigational agent, whichever is longer.
    The Sponsor may grant inclusion approval on an individual basis if it is
    determined unlikely that the investigational agent would have an effect on MRI
    lesions during the screening or treatment period.
    11. Are pregnant, nursing, or planning pregnancy (both men and women) within 1
    year after the last study agent injection(s).
    12. Have a history of a previous immediate hypersensitivity response including
    anaphylaxis or a severe allergic reaction to monoclonal antibodies.
    13. Have a chest x-ray at screening or within 2 months prior to screening that shows
    evidence of malignancy, infection, or any abnormalities suggestive of TB as
    described in Section 4.3.2. of the protocol.
    14. Have laboratory evidence of any of the following:
    * Hemoglobin < 8.0 gm/dL
    * WBC count < 3.0 x 1,000,000,000 cells/L
    * Neutrophil count < 1.5 x 1,000,000,000 cells/L
    * Platelet count < 100 x 1,000,000,000 cells/L
    * Serum transaminase levels > 1.5 times the upper limit of normal for the clinical
    laboratory
    * Serum creatinine levels > twice the upper limit of the normal reference
    rangefor the clinical laboratory, unless calculated creatinine clearance is
    > 30mL/min.
    15. Have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), a chronic
    or serious recurring infection, hospitalization for infection, or treatment with IV
    antibiotics for infection within 2 months prior to screening. Less serious
    infections (eg, acute upper respiratory tract infection or uncomplicated urinary
    tract infection) need not be considered exclusions at the discretion of the
    investigator.
    16. Have or have had opportunistic infections (eg, cytomegalovirus [CMV],
    Pneumocystis carinii, histoplasmosis or any mycobacterial infection other than
    TB) within 6 months prior to randomization.
    17. Have a known or suspected diagnosis of asthma.
    18. Have documented current or past infection with hepatitis B or C.
    19. Have documented human immunodeficiency virus (HIV) infection.
    20. Have presence of a transplanted organ (with the exception of a corneal
    transplant performed > 3 months prior to randomization).
    21. Have a known malignancy or history of malignancy within the previous 5 years
    (with the exception of basal cell carcinoma of the skin that has been treated with
    no evidence of recurrence).
    22. Have a history of lymphoproliferative disease including lymphoma, or signs and
    symptoms suggestive of possible lymphoproliferative disease.
    23. Have a history of alcohol or substance abuse within the preceding 6 months
    that, in the opinion of the investigator, may increase the risks associated with
    study participation, or study agent administration, or may interfere with
    interpretation of results.
    24. Are considered ineligible according to the country-specific TB screening guidelines
    for latent TB defined in Section 4.3. of the protocol.
    25. Have a contradiction to obtaining an MRI or are unable to tolerate MRI
    procedures.
    26. Have received a BCG vaccination within 1 year prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    The cumulative number of new Gd-enhancing T1-weighted lesions on cranial MRIs through week 23.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The study will be conducted with 2 subject cohorts
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months10
    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 months6
    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) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-09-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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 Decision2004-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-28
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