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    Summary
    EudraCT Number:2009-012675-10
    Sponsor's Protocol Code Number:D4050169
    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:2009-08-07
    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 number2009-012675-10
    A.3Full title of the trial
    An exploratory, randomised, double blind, placebo controlled, 14 day, two-way crossover, inhaled allergen challenge study to evaluate the effects of SMP-028 in subjects with mild to moderate asthma
    A.3.2Name or abbreviated title of the trial where available
    SMP-028 Inhaled Allergen Challenge study
    A.4.1Sponsor's protocol code numberD4050169
    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 SponsorDainippon Sumitomo Pharma Europe 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 nameSMP-028
    D.3.2Product code SMP-028
    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.3.8INN - Proposed INNSMP-028
    D.3.9.2Current sponsor codeSMP-028
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeSMP-028 is an oral anti-allergic drug candidate
    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 placeboTablet
    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
    Asthma and Allergic Rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the effect of treatment with repeat doses of SMP-028 on the late asthmatic response (LAR) to inhaled allergen challenge in mild to moderate asthmatic subjects.
    E.2.2Secondary objectives of the trial
    In mild to moderate asthmatic subjects:
    •To evaluate the effect of treatment with repeat doses of SMP-028 on the early asthmatic response (EAR) to inhaled allergen challenge
    •To evaluate the effect of treatment with repeat doses of SMP-028 on lung function as measured by FEV1 on Day 13.
    •To evaluate the effect of treatment with repeat doses of SMP-028 on exhaled NO on Days 13 and 14.
    •To evaluate the effect of treatment with repeat doses of SMP-028 on bronchial hyper-reactivity as measured by AMP challenge on Day 14.
    •To evaluate the effect of treatment with repeat doses of SMP-028 on induced sputum post- allergen challenge on Day 14.
    •To assess the safety and tolerability of treatment with repeat doses of SMP-028.
    •To evaluate the multiple dose PK of SMP-028 and its M3 and M5 metabolites.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male subjects and females of non-child bearing potential (e.g. post-menopausal (no menstrual bleeding for at least the preceding 12 months) or surgically sterilised), between 18 and 65 years of age inclusive.
    •Documented history of bronchial asthma, first diagnosed at least 6 months prior to the Screening visit and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
    •Pre-bronchodilator FEV1 >65% of predicted at Screening.
    •Demonstration of a positive wheal reaction (≥ 3 mm relative to negative control) to at least one of three allergens (house dust mite, grass pollen, cat hair and dander) on skin prick testing at Screening, or within 12 months of study start.
    •Screening allergen challenge demonstrating that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of ≥ 20% from the post-saline or diluent value, on at least 1 occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of ≥ 15% from the post-saline or diluent value, on at least 3 occasions, 2 of which must be consecutive, between 4 and 10 hours after the final concentration of allergen.
    •Sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of < 80mg/mL at Screening.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    •Past or present disease, which as judged by the Investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
    •Subject has known history of uncontrolled hypertension or is hypertensive at Screening. Hypertension at Screening is defined as persistent systolic blood pressure (BP) >150mmHg or diastolic BP > 90mmHg. Subjects with well controlled essential hypertension may be enrolled provided that their antihypertensive medication(s) are permitted.
    •Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study drug.
    •Symptomatic allergic rhinitis (those with a history of allergic rhinitis may participate if asymptomatic at Screening and if, in the opinion of the Investigator, it is unlikely that disease exacerbation will occur during the course of the study.
    •History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
    •Administration of oral, injectable or dermal steroids within 3 months and/or inhaled steroids within 1 month of the Screening Visit.
    •Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-agonists within 1 week prior to Screening and is unable to abstain from them throughout the study.
    •History of being unable to tolerate or complete AMP or allergen challenge tests.
    •If on more than two occasions, after 2 concurrent administrations of saline during the allergen challenge at Screening the subjects still have a fall in FEV1 of greater than 10%.
    E.5 End points
    E.5.1Primary end point(s)
    •Mean baseline-corrected area under the FEV1 reduction curve from 4 to 10 hours after allergen challenge (AUC4-10h) on Day 13 of each treatment period.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory study
    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 Yes
    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.8.3 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 concerned2
    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 No
    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
    The end of the study is defined as the last subject undergoing the last visit of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days21
    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) 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 state24
    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)
    SMP-028 is in an early stage of development and as such continued treatment with this drug following the end of the subject participation in the study cannot be offered. At the end of the study, subjects will receive standard medical care for their condition in accordance with current local practice.
    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 Decision2009-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-11
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