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    Summary
    EudraCT Number:2014-003846-29
    Sponsor's Protocol Code Number:01.1.1.H3
    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:2014-10-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-003846-29
    A.3Full title of the trial
    A Phase IIA randomized, double-blind, placebo controlled, cross-over study to evaluate the effects of multiple doses of inhaled RNS60 and Budesonide on the late phase asthmatic response to allergen challenge in patients with mild asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Assess the Effect of RNS60 and Budesonide in Asthmatic Patients
    A.4.1Sponsor's protocol code number01.1.1.H3
    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 SponsorRevalesio Corporation
    B.1.3.4CountryUnited States
    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 supportRevalesio Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRevalesio Corporation
    B.5.2Functional name of contact pointSupurna Ghosh
    B.5.3 Address:
    B.5.3.1Street Address1200 East D Street
    B.5.3.2Town/ cityTacoma
    B.5.3.3Post codeWA 98421
    B.5.3.4CountryUnited States
    B.5.4Telephone number12539222600
    B.5.5Fax number12539226247
    B.5.6E-mailsghosh@revalesio.com
    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 nameRNS60
    D.3.2Product code RNS60
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRNS60
    D.3.9.3Other descriptive nameSODIUM CHLORIDE for irrigation with dissolved USP Oxygen
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation 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
    Allergy-mediated inflammation of the airways of the lungs
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of treatment with RNS60 on the response to allergen challenge compared to placebo (0.9% saline) in subjects with mild asthma.
    To assess the safety and tolerability of multiple doses of RNS60 in subjects with mild asthma.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female subjects aged 18 to 65 years inclusive;
    • Subjects with a body weight ≥50 kg and a body mass index (BMI) between 18.0 - 32.0
    • Subjects should be steroid-naïve (within 3 months of screening for oral corticosteroids and within 28 days of screening for inhaled corticosteroids), with mild asthma, but be otherwise healthy;
    • Male subjects should agree to not donate sperm from first dose until 3 months post-last dose;
    • Male subjects (with female partners of child bearing potential) and female subjects of child bearing potential should use two methods of highly effective contraception;
    • Subjects should be non-smokers; ex-smokers must not have smoked for at least 12 months, and have smoked less than a packet of cigarettes a day for 10 years, or equivalent;
    • Subjects should be taking only reliever medication for their asthma Antihistamines will be permitted up to 7 days prior to the first screening visit;
    • Lung function (blowing tests) must be 70% of the predicted normal value for age, height and sex at screening and prior to first dose administration;
    • Must show significant irritability of the airways when inhaling a mist of methacholine
    • Documented allergy to at least one common allergen (house dust mite, grass pollen allergens or cat dander) as confirmed by a skin prick test. Historical data (up to 1 year) may be used;
    • Must show significant irritability of the airways when inhaling a mist of an allergen they’re allergic to on skin prick testing.

    E.4Principal exclusion criteria
    • Subjects with evidence or history of clinically significant illness (excluding mild asthma);
    • Significant worsening of asthma in the 4 weeks preceding the screening visit requiring treatment above and beyond the usual preventer;
    • A respiratory infection in the 4 weeks preceding the first screening visit or prior to Day 1, Period 1;
    • Use of any immunotherapy within 3 months prior to first screening;
    • Regular use of medications;
    • Use of preventer medication for the treatment of asthma in the 4 weeks before screening is not allowed, and throughout participation in the study;
    • Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
    • History of life-threatening asthma;
    • Nasal Symptoms of allergy requiring treatment, at screening or predicted to require treatment during the study;
    • History of severe allergy;
    • Clinically significant abnormalities found on physical examination or in laboratory test results;
    • Subjects who have received any investigational drug in any clinical trial within 3 months, or who are on extended follow-up;
    • Subjects who are vegans or have medical dietary restrictions;
    • Patients who take concomitant treatment with herbal medication/supplements or St John’s Wort;
    • Subjects with a supine systolic blood pressure (SBP) ≥160 mmHg or a supine diastolic blood pressure (DBP) ≥100 mmHg at screening or prior to Day 1 Period 1;
    • History of alcohol abuse or drug addiction or positive alcohol test;
    • Positive screen on hepatitis B, hepatitis C, or antibodies to the human immunodeficiency virus (HIV);
    • Clinically significant abnormal 12-lead ECG or one demonstrating QTcF >450 ms at screening;
    • Significantly abnormal liver enzymes (alanine aminotransferase [ALT] >1.5 x upper limit of normal [ULN] or total bilirubin >1.5x ULN);
    • Subjects who cannot communicate reliably with the Investigator; and
    • Subjects who are unlikely to co-operate with the requirements of the study.

    E.5 End points
    E.5.1Primary end point(s)
    Emax(3-8): The maximal percentage decrease
    from the pre-allergen challenge (post-diluentvalue) in FEV1 during 3 hours to 8 hours post- allergen challenge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 Days (please see protocol)
    E.5.2Secondary end point(s)
    • Emax(o-3): max % decrease from the pre-allergen challenge (post-diluent value) in FEV1 during the first 3 hours post- allergen challenge (0 to 3 hours).
    • Emax(3-8): The max % decrease from the pre-allergen challenge (post-diluent
    value) in FEV1 between 3 hours and 8 hours post- allergen challenge (3 to 8 hours).
    • AUEC(o-3): The area under the effect curve (AUEC) between 0 hours and 3 hours post-allergen challenge (using change from baseline FEV1
    values, with post-diluent challenge value in FEV 1
    as baseline). The parameter will be calculated using linear trapezoidal method.
    • AUEC(3•Bl: The area under the effect curve (AUEC) between 3 hours and 8 hours post- allergen challenge (using change from baseline FEV1 values, with post-diluent challenge value in FEV1 as baseline), using linear trapezoidal method.
    • Eavg(0-3) based upon AUEC(o-3)
    • Eavg(3-SJ based upon AUEC<3.8l
    • Emin,0.3l: The minimal percentage decrease from the pre-allergen challenge (post-diluent value) in FEV1 during the first 3 hours post-allergen challenge (0 to 3 hours).
    • Emin<3.8l: The minimal percentage decrease from the pre-allergen challenge (post-diluent value) in FEV1 between 3 hours and 8 hours post-allergen challenge (0 to 3 hours).
    • Absolute count and percentage differential in sputum eosinophils at approximately 8 hours after allergen challenge;
    • Absolute count and percentage differential in sputum neutrophils at approximately 8 hours after allergen challenge;
    • Change and percent change from baseline
    (screening) in eosinophils and neutrophils at
    8 hours post-allergen challenge.

    E.5.2.1Timepoint(s) of evaluation of this end point
    21 Days (please see protocol)
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    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.8.5The 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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days2
    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: 32
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.4.2.2In the whole clinical trial 32
    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 Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-10
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