Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-002470-46
    Sponsor's Protocol Code Number:CIM003JG
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-002470-46
    A.3Full title of the trial
    A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II repeated dose, randomized and blinded trial of CIM331 in patients with eczema in whom products applied to the skin do not provide sufficient relief or produce side effects
    A.4.1Sponsor's protocol code numberCIM003JG
    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 SponsorChugai Pharmaceutical Co. Ltd
    B.1.3.4CountryJapan
    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 supportChugai Pharmaceutical Co. Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChugai Pharma Marketing Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressMulliner House, Flanders Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW4 1NN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089875680
    B.5.5Fax number442089875661
    B.5.6E-mailregulatory@chugai-pharm.co.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 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 nameCIM331
    D.3.2Product code CIM331
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNhumanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A
    D.3.9.2Current sponsor codeCIM331
    D.3.9.3Other descriptive namehumanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 placeboLyophilisate 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
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Eczema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To evaluate the dose response profile of CIM331 in the treatment of pruritus as defined by the percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus VAS (Part A).
    E.2.2Secondary objectives of the trial
    1) To further evaluate the efficacy of CIM331 compared with placebo as measured by the EASI, SCORAD, sIGA, BSA of AD involvement, pruritus VAS, pruritus VRS, sleep disturbance VAS, time to rescue therapy, and proportion of patients receiving rescue therapy.
    2) To evaluate the long-term efficacy profile of CIM331 (Part B).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria – Part A
    Patients must meet the following criteria for study entry:
    1. ≥18 and ≤65 years of age at the time of consent.
    2. Patients must be able to give written informed consent and comply with the requirements of the study protocol.
    3. Patients must satisfy the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka.
    4. Patients must meet either a or b and c, d at the screening visit (Day -28 to Day -8):
    a.Patients must have a history of inadequate response (defined as sIGA score ≥3) to a stable regimen ≥4* consecutive weeks of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI).
    Note: TCS must be “potent” or “very potent” according to the classification provided.
    *Note: A TCS which is restricted for use <4 weeks in duration (e.g. clobetasol propionate) should be applied to the maximum allowed consecutive treatment period which may be <4 consecutive weeks.
    b. Patients must have a history of intolerance to, or inability to receive, standard topical therapy (e.g. contraindication). Intolerance is defined as discontinuation due to allergy to TCS and/or TCI.
    Note: criteria c and d should only be assessed in patients who meet criteria a or b:
    c. EASI ≥10.
    d. Pruritus VAS ≥50 mm.
    5. Patients must meet the following criteria at randomization:
    a. Pruritus VAS ≥50 mm (last 3 consecutive days of the run-in period).
    b. EASI ≥10.
    c. sIGA score ≥3.
    6. Both male and female patients of childbearing potential must agree for the duration of the study and for a period of 120 days after administration of the last dose of study drug to the consistent and correct use of an acceptable method of birth control (i.e. methods of birth control which result in a low failure rate [<1% per year] when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or surgically sterilized partner).

    Inclusion Criteria (Part B only)
    1. Patients who have completed the treatment period for Part A.
    2. Patients who are willing to participate in Part B and are able to give written informed consent and comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    Exclusion Criteria (Part A and Part B)
    Patients who meet any of the following criteria will be excluded from study entry:
    1. Known significant cardiac disease (New York Heart Association Class III or IV).
    2. Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding, including aspartate aminotransferase or alanine aminotransferase >2 x upper limit of normal (ULN), or serum creatinine ≥2 mg/dL (177 µmol/L), or total white blood cells (WBC) <3000 cells/µL, or any other medical condition that, in the opinion of the Investigator, would contraindicate the use of an investigational drug.
    3. Clinically significant electrocardiogram (ECG) abnormalities.
    4. History of drug dependence or alcohol abuse.
    5. Serological evidence of hepatitis B virus (hepatitis B surface antigen positive or hepatitis B core antibody positive) or hepatitis C virus (HCV) (anti-HCV antibody positive) infection (active or past infection). Testing prior to the study is mandatory.
    6. Known human immunodeficiency virus (HIV) infection.
    7. History of hypersensitivity, including anaphylaxis to an immunoglobulin product (plasma derived or recombinant, e.g. monoclonal antibody).
    8. History of skin malignancy. Patients with a history of any other malignancy, who have been in remission for ≥5 years prior to randomization, or patients with a history of curatively treated in situ carcinoma of the cervix at any time prior to randomization, are eligible.
    9. Active dermatological disease other than AD, which is being treated separately.
    10. Eye disease requiring systemic treatment.
    11. Ongoing treatment with specific or non-specific hyposensitization therapy for AD.
    12. Treatment with systemic steroids, immunosuppressant agents or ultraviolet radiation therapy within 4 weeks prior to randomization.
    13. Treatment with potent or very potent TCS within 2 weeks prior to randomization.
    14. Treatment with mild or moderately potent TCS within 1 week prior to randomization.
    15. Patients who have been receiving treatment for asthma within 1 year prior to randomization or who had previously been diagnosed with asthma and experienced asthmatic symptoms (including, but not limited to, wheezing, shortness of breath, cough after exercise) within 1 year prior to randomization.
    16. Treated with TCI or vitamin D (including activated vitamin D) within 2 weeks prior to randomization.
    17. Treated with an antihistamine (topical or systemic) within 1 week prior to randomization.
    18. Treatment with a hypnotic within 1 week prior to randomization.
    19. Treatment with any other therapy for AD and pruritus, including emollients (e.g. Atopiclair®, MimyX™) approved or cleared by FDA as devices, within 4 days prior to randomization.
    20. History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
    21. Treatment with any investigational agent including placebo within 16 weeks prior to randomization.
    22. <All countries except Germany>Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) skin test and/or positive interferon-gamma release assay. Such patients may participate in the study if further diagnostic work-up according to local guidelines (including chest X-ray if appropriate) reveals no evidence of latent or active TB. The interferon-gamma release assay should be repeated in case of an indeterminate result.
    <Germany only>Evidence of TB infection as defined by a positive PPD skin test and/or positive interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result.
    23. Received a live vaccine within 4 weeks prior to randomization or plan to receive a live vaccine during the study.
    24. Received a non-live vaccine (toxoid or killed infectious agent) within 1 week prior to randomization or plan to receive a non-live vaccine during the study.
    25. Pregnant or lactating women.
    26. Previous treatment with CIM331.

    Exclusion Criteria (Part B only)
    1. Patients who experienced a serious adverse event thought to be related to treatment with CIM331 in Part A.
    E.5 End points
    E.5.1Primary end point(s)
    Percent improvement from baseline in pruritus VAS at Week 12 (Part A).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Secondary efficacy outcome measures (Part A and Part B):
     Improvement from baseline in pruritus VAS, EASI, SCORAD, sIGA, Body Surface Area (BSA) of AD involvement, pruritus VRS and sleep disturbance VAS at Week 12 and selected time points.
     EASI: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points.
     SCORAD: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points.
     sIGA: Proportion of patients with a 2 or more point improvement from baseline at Week 12 and selected time points.
     Pruritus VAS: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points.
     Pruritus VRS: proportion of patients with a 2 or more point improvement from baseline at Week 12 and selected time points.
     Time to response of pruritus VAS improvement from baseline 25%, 50%, 75%.
     Time to response of EASI improvement from baseline 25%, 50%, 75%.
     Time to response of SCORAD improvement from baseline 25%, 50%, 75%.
     Time to response of 2 point improvement from baseline of sIGA.
     Time to rescue therapy.
     Proportion of patients receiving rescue therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and selected time points.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial5
    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 concerned4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Japan
    Poland
    United Kingdom
    United States
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 250
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 250
    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 Decision2013-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-06
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA