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    Summary
    EudraCT Number:2015-002555-10
    Sponsor's Protocol Code Number:ORCA2015
    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:2015-09-29
    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 number2015-002555-10
    A.3Full title of the trial
    Effect of the CRTH2 antagonist OC459 on the response to rhinovirus challenge in asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to see whether the drug OC459 reduces the asthma symptoms induced by infection with the common cold
    A.3.2Name or abbreviated title of the trial where available
    Effect of OC459 on the response to rhinovirus challenge in asthma
    A.4.1Sponsor's protocol code numberORCA2015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02660489
    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 SponsorImperial College
    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
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAtopix Therapeutics Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College
    B.5.2Functional name of contact pointDr Hugo Farne
    B.5.3 Address:
    B.5.3.1Street AddressSt Mary's Medical School Campus Building, Imperial College, Norfolk Place,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW2 1PG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number07886033770
    B.5.6E-mailh.farne@imperial.ac.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 nameOC459
    D.3.2Product code OC000459
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNOC000459
    D.3.9.2Current sponsor codeOC000459
    D.3.9.3Other descriptive nameODC9101, OC459
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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 No
    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 placeboFilm-coated tablet
    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
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000015470
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049868
    E.1.2Term Asthma exacerbation prophylaxis
    E.1.2System Organ Class 100000022885
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003638
    E.1.2Term Atopic asthma
    E.1.2System Organ Class 100000015470
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10015575
    E.1.2Term Exacerbation of asthma
    E.1.2System Organ Class 100000015470
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall aim of this study is to assess the effectiveness of the study drug (OC459) in preventing or attenuating the worsening of asthma symptoms (an asthma exacerbation) that occurs when asthma sufferers catch a cold (defined as an infection with the virus rhinovirus). The study drug will be compared with a placebo to find out the extent of any improvement in the condition of the participants. A placebo is a medically noneffective copy of the drug being tested; it looks and tastes the same as the treatment drug (it can be seen as a dummy drug).

    In healthy subjects, rhinovirus infection causes symptoms of a cold e.g. sneezing, runny nose. In patients with asthma, rhinovirus infection causes a worsening of their asthma symptoms (e.g. breathlessness, wheeze) because of the way the immune system reacts to the virus. The study drug OC459 blocks activation of receptor cells found in the immune system and by blocking that activation may prevent an exacerbation of symptoms.

    Changes in as
    E.2.2Secondary objectives of the trial
    Our secondary objectives are to:
    1) Determine the influence of the study drug OC459 on other clinical and laboratory parameters during rhinovirus infection:
    • Health status, as assessed by validated questionnaires
    • Lung function, measured both using a home spirometer which we will provide and on subject visits
    • Exhaled nitric oxide (FeNO) levels in the breath, which are a marker of inflamed airways
    • Airway hyperresponsiveness, measured in a histamine challenge test, a routine test that quantifies the degree of airway narrowing in patients with asthma
    • Viral load, i.e. the number of copies of rhinovirus in nasal and bronchoscopic samples
    2) Determine the mechanism of action of the study drug OC459, by assessing its impact on inflammatory cell numbers and inflammatory mediators in samples from the nose and lower airways (sputum and bronchoscopic samples)
    3) Determine whether the study drug OC459 restores previously observed deficiencies in antiviral immunity in patients with asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-55 years
    • Male or female
    • Clinical diagnosis of asthma for at least 6 months prior to screening
    • An Asthma Control Questionnaire (ACQ) Score >0.75
    • Positive histamine challenge test (PC20 <8 µg/ml, or <12 µg/ml and bronchodilator response ≥ 12%)
    • Worsening asthma symptoms with infection since last change in asthma therapy
    • Positive skin prick test to common aeroallergens (e.g. animal epithelia, dust mite)
    • Treatment comprising inhaled corticosteroids (ICS) or combination inhaler (Long-Acting Beta Agonist with ICS), with a daily ICS dose of at least 100mcg fluticasone or equivalent.
    • Participant is willing for their GP to be informed of their participation.
    • English speaker
    E.4Principal exclusion criteria
    • Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, pulmonary, neurological, genitourinary, autoimmune, endocrine, metabolic, neoplasia etc.), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it
    • Smoking history over past 12 months.
    • Seasonal allergic rhinitis symptoms at screening or during the 3 week run-in (prior to rhinovirus inoculation).
    • Asthma exacerbation or viral illness within the previous 6 weeks or during the 3 week run-in (prior to rhinovirus inoculation).
    • Current or concomitant use of oral steroids, anti-leukotrienes or monoclonal antibodies.
    • Pregnant or breast-feeding women. Patients should not be enrolled if they plan to become pregnant during the time of study participation (see note regarding contraception below).
    • Contact with infants <6 months or immunocompromised persons, elderly and infirm at home or at work.
    • Subjects who have known evidence of lack of adherence to medications and/or ability to follow physician’s recommendations.
    E.5 End points
    E.5.1Primary end point(s)
    Total Lower Respiratory Tract Symptoms Score after rhinovirus infection (sum of daily scores for 2 weeks after rhinovirus inoculation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be assessed on day 14 post-rhinovirus inoculation.
    E.5.2Secondary end point(s)
    Difference between OC459 and placebo groups in the following (all measured as peak and change from baseline):
    • Increase in ACQ score (health status)
    • Reduction in Forced Expiratory Volume in 1 second (FEV1) or Peak Expiratory Flow (PEF) on spirometry
    • Increase in FeNO
    • Decrease in PC20
    • Virus load in nasal lavage – total (area under the curve) for days 2-5+7+10, as well as peak and difference from baseline
    • Increase in sputum eosinophilia
    • Leukocyte numbers (e.g. ILC2, Th2) in FACS-sorted BAL, serum and nasal scrapes, and in immunohistochemistry-stained biopsies
    • Cytokine levels (e.g. IL-4, IL-5, IL-13) in nasosorption, nasal lavage, bronchosorption, BAL
    • mRNA expression of same cytokines in cells in BAL and bronchial biopsies
    • In ex vivo studies, protein and mRNA levels of antiviral cytokines (e.g. IFN-α, IFN-λ) produced by cells from blood, BAL, and bronchial brushings in response to rhinovirus infection
    • Difference in number of adverse events in OC459 and placebo groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be assessed prior to (days -8 and -7), during, and at the end of rhinovirus infection (days 0 to 14). Some endpoints (e.g. leukocyte numbers) will additionally be assessed at the first baseline visit, prior to the first dose of the study drug, to assess the effect of the drug.

    In addition health status and lung function will be assessed by participants at home, and once more by investigators, 6 weeks after rhinovirus inoculation (day 42).
    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 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 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 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.8.6 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 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
    Last visit of the last subject (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days1
    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: 44
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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)
    Subjects will continue with their normal treatment under routine follow up after the trial.
    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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-18
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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