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    The EU Clinical Trials Register currently displays   35479   clinical trials with a EudraCT protocol, of which   5824   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).
     
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    Summary
    EudraCT Number:2007-000190-28
    Sponsor's Protocol Code Number:IMD-10412002-1
    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:2011-02-23
    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 number2007-000190-28
    A.3Full title of the trial
    A Single Centre, Double-blind, Randomised Study To Investigate a Single Oral Dose of IMD-1041 in A Nasal Allergen Challenge (NAC) Model
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single Centre, Double-blind, Randomised Study To Investigate a Single Oral Dose of IMD-1041 in A Nasal Allergen Challenge (NAC) Model
    A.4.1Sponsor's protocol code numberIMD-10412002-1
    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 SponsorInstitute of Medicinal Molecular Design Inc
    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 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 nameIMD-1041
    D.3.2Product code IMD-1041
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeIMD-10412002-1
    D.3.9.3Other descriptive nameN-[3,5-Bis(trifluoromethyl)phenyl]-5-chloro-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    It is intended to investigate the potential therapeutic benefit of IKKβ inhibition in man by oral dosing of IMD-1041 in a Nasal Alllergen Challenge.
    E.1.1.1Medical condition in easily understood language
    It is intended to investigate the potential therapeutic benefit of IKKβ inhibition in man by oral dosing of IMD-1041 in a Nasal Alllergen Challenge.
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10053467
    E.1.2Term Antiinflammatory therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the potential therapeutic benefit of IKKβ inhibition in man by oral dosing of IMD-1041 in NAC model. To evaluate safety, efficacy and effects on key pathological parameters of IMD-1041 in patients with allergic rhinitis due to grass pollen (hayfever).
    E.2.2Secondary objectives of the trial
    To investigate the effects of IMD-1041 on NF-κB inhibition ex vivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy male, non-smoking subjects aged between 18 and 60 years inclusive, and in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening. A history of symptoms of seasonal grass pollen related allergic rhinitis in the previous two years. In the UK, this involves nasal symptoms between June and August Allergy defined by a positive skin prick test response to Timothy grass pollen, with a wheal of diameter ≥ 3mm larger than the negative control response. This may have been detected on skin testing at any time in the past 12 months. Lack of nasal symptoms suggestive of allergic rhinitis in the 3 days before each study visit. Normal appearing nasal mucosa with no active allergic rhinitis on screening Spirometry testing: forced expiratory volume in 1 second (FEV1) within normal limits (≥ 80 % predicted) Normal findings on clinical examination on screening. A subject with a clinical abnormality may be included only if the Principal investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures. Normal laboratory findings on screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the Principal Investigator considers that such findings will not introduce additional risk factors, or interfere with study procedures. Normal 12-Lead electrocardiogram (ECG) on screening. Read, comprehend and write English at a sufficient level to complete study related materials. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions in the consent form.
    E.4Principal exclusion criteria
    Smokers that use tobacco products in the past 3 months. Signs or symptoms of rhinitis at the time of study entry. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases. Presence of any respiratory diseases other than mild stable asthma not requiring treatment. Clinical features suspicious of tuberculosis – weight loss, pyrexia, haemoptysis cough with purulent sputum Infection of the upper airways or lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and throughout study visits A history of hypersensitivity/anaphylaxis to any of the challenge agents employed in this study FEV1≤ 70% predicted prior to each nasal challenge Subjects with a positive exhaled carbon monoxide test. Positive urine drug screen at pre-study medical History of abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for females and 28 units or an average daily intake of greater than 4 units for males. Participation in a clinical trial with a new molecule entity within 3 months of the start of the study. Volunteers who have a clinical history of hepatitis B or C, or HIV infection. Donation or loss of 450 ml or more blood within the previous 12 weeks Clinically significant abnormality in clinical laboratory tests at screening as determined by the Principal Investigator Volunteers who in the opinion of the Principal Investigator are at risk of noncompliance or not completing the study procedures and schedule Any infirmity, disability, or geographic location, which, in the opinion of the Principal Investigator, would limit compliance with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of safety, efficacy and potential therapeutic benefit of IKKB inhibition in man by oral dosing of IMD-1041.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other Information not present in EudraCT
    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 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.8.6 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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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 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.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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 Decision2007-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-08
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