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    Summary
    EudraCT Number:2017-003544-20
    Sponsor's Protocol Code Number:207972
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003544-20
    A.3Full title of the trial
    A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Repeat dose study of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD)
    A.3.2Name or abbreviated title of the trial where available
    PH2a,12-week, 3 RD of 10 mg/kg IV every 4 weeks, efficacy and safety study in asthma pts with AFAD
    A.4.1Sponsor's protocol code number207972
    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 SponsorGlaxoSmithKline Research & Development 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 supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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.3.2Product code GSK3772847
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone
    D.3.9.1CAS number None
    D.3.9.2Current sponsor codeGSK3772847
    D.3.9.3Other descriptive nameAnti-IL33R
    D.3.9.4EV Substance CodeSUB188496
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    asthma with allergic fungal airway disease (AFAD).
    E.1.1.1Medical condition in easily understood language
    asthma with allergic fungal airway disease (AFAD).
    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 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 evaluate the efficacy of 3 doses of GSK3772847 (administered every 4 weeks)
    compared with placebo in moderate to severe asthma participants with allergic fungal airway disease (AFAD) who are currently on Standard of Care (SoC)
    E.2.2Secondary objectives of the trial
    To evaluate the serum pharmacokinetics (PK) of 3 doses of GSK3772847 (administered every 4 weeks) in moderate to severe asthma participants with AFAD
    To evaluate the pharmacodynamics (PD) of GSK3772847 in moderate to severe asthma participants with AFAD
    To evaluate the levels and specificity of any anti-drug antibodies formed following dosing with GSK3772847
    To evaluate the health status of moderate to severe asthma participants with AFAD currently on SoC, and who are treated with GSK3772847 compared with placebo-treated participants
    To evaluate the effect on lung function of moderate to severe asthma participants with AFAD currently on SoC, treated with GSK3772847
    compared with placebo
    To evaluate the safety and tolerability of GSK3772847 compared with placebo in
    moderate to severe asthma participants with AFAD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. Participant must be at least 18 years of age inclusive, at the time of signing the
    informed consent.
    Type of Participant and Disease Characteristics
    2. Documented history of physician diagnosed moderate or severe asthma for ≥12 months based on [GINA, 2017] Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (≥500 µg/day fluticasone propionate or equivalent as defined in the [GINA, 2017] guidelines.
    Additional therapy: with low dose orl corticosteroid (<= 10 mg/dayprednisolone or equivalent), with a leukotriene receptor antagonist (LTRA), with
    anticholinergics, with anti-fungal medication is permissible.
    3. Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive
    4. FeNO ≥ 25ppb at Screening (Visit 1)
    5. ACQ-5 score ≥1.5 at Screening (Visit 1)
    6. Blood eosinophils ≥ 300 cells/microliter at Screening (Visit 1). Participants with eosinophils of 250-299 cells/microliters (inclusive) at screening but with documented evidence of >= 300 cells/microliters within 5 months of screening will be eligible for the study.
    7. Evidence of allergic fungal airway disease:
    Fungal sensitisation to at least one of the following fungi: Aspergillus fumigatus,
    Penicillium chrysogenum (notatum) at screening measured by serum-specific IgE
    test. Documented fungal sensitisation either by serum-specific IgE or skin prick test is also acceptable.
    A history of exacerbations (at least 1 severe exacerbation (defined as requiring a
    minimum of 3 days of high-dose oral corticosteroids [>10 mg/day prednisolone or equivalent] for asthma symptoms) in the
    previous 12 months.
    Weight
    8. Body weight within 50-150 kg (inclusive).
    Sex
    9. Male and female
    a. Female participants:
    A female participant is eligible to participate if she is not pregnant (as defined in the protocol), not breastfeeding, and at least one of the following conditions applies:
    i. Not a woman of childbearing potential (WOCBP) as defined in the protocol
    OR
    ii. A WOCBP who agrees to follow the contraceptive guidance in the protocol
    during the treatment period and for at least 16 weeks after the last dose of
    study treatment.
    Informed Consent
    10. Capable of giving signed informed consent as described in the protocol which
    includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. Historical diagnosis of cystic fibrosis
    2. Concurrent respiratory diseases: Presence of a known pre-existing, clinically
    important respiratory conditions (e.g. pneumonia, pneumothorax, atelectasis
    segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD
    3. Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer
    4. Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalised for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug
    5. Evidence of poorly controlled chronic medical conditions other than asthma, e.g., patients with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and haematological or any other system abnormalities that are uncontrolled with standard treatment.
    6. Cardiovascular disease: Clinically significant organic heart disease (e.g. CAD,
    NYHA Class III/IV heart failure).
    7. Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the patient has been considered cured by treatment..
    8. Eosinophilic diseases: Other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1).
    Prior/Concomitant Therapy
    9. Use of the medications listed in Table 2 of the protocol in exclusion criteria section, is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study. Potential participants should not be washed out of their medication solely for the purpose on enrolling in the trial.
    Diagnostic assessments
    10. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
    11. A known immunodeficiency such as human immunodeficiency virus infection.
    12. Hypersensitivity: significant allergies to humanised monoclonal antibodies or
    biologic or to any components of the formulation used in this study.
    13. Clinically significant multiple or severe drug allergies, intolerance to topical
    corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin a dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
    14. Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1).
    Site investigators will be provided with ECG over-read conducted by a centralised
    independent cardiologist, to assist in evaluation of participant eligibility. For this
    study, an abnormal and clinically significant ECG that would preclude a participant from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the findings in Table 3 of the protocol in exclusion criteria section).
    Other Exclusions
    15. Smoking history: current smokers or former smokers with a smoking history ≥10 pack years (pack years = number of cigarettes smoked per day / 20 * number of years smoked).
    16. History of alcohol or illegal substance abuse within 2 years prior to Screening
    (Visit1).
    17. Participants at risk of non-compliance, or unable to comply with the study
    procedures. Participants who are unable to follow study instructions such as visit
    schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician’s
    recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
    E.5 End points
    E.5.1Primary end point(s)
    •Change from baseline (Week 0) in blood eosinophils over time
    •Change from baseline (Week 0) in fractional exhaled nitric oxide (FeNO) over time
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 2, 4, 8 and 12.
    E.5.2Secondary end point(s)
    •Serum concentrations of GSK3772847
    •Serum levels of free and total soluble ST2
    •Incidence and titres of serum anti-GSK3772847 antibodies post dosing
    •Change from baseline (Week 0) in Asthma Control Questionnaire -5 (ACQ-5) absolute score
    •Change from baseline (Week 0) in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores
    •Proportion of responders to ACQ-5. A responder to ACQ-5 will be defined as a subject who has a decrease from baseline in ACQ-5 score of 0.5 or more.
    •Proportion of responders to AQLQ. A responder to AQLQ will be defined as a subject who has an increase from baseline in AQLQ score of 0.5 or more.
    •Change from baseline (Week 0) in spirometry parameters
    •Safety and tolerability [Treatment emergent adverse events (AE); Clinical Laboratory safety data; Vital signs (blood pressure, heart rate, body temperature); 12–Lead Electrocardiogram (ECG) monitoring; 24-hour Holter monitoring]
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Serum concentrations of GSK3772847 at weeks 0 to 24. •Serum levels of free and total soluble ST2 at weeks 0-24. •Incidence and titres of serum anti-GSK3772847 antibodies post dosing at weeks 0-24. •Change from baseline (Week 0) in Asthma Control Questionnaire -5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12 •Change from baseline (Week 0) in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12 •Proportion of responders to ACQ-5. A responder to ACQ-5 will be defined as a subject who has a decrease from baseline in ACQ-5 score of 0.5 or more at Weeks 2, 4, 8 and 12 •Proportion of responders to AQLQ. A responder to AQLQ will be defined as a subject who has an increase from baseline in AQLQ score of 0.5 or more at Weeks 2, 4, 8 and 12.Refer 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    sponsor open to selected study team members for interim analysis
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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)
    Participants will not receive any additional treatment from GSK after completion of the
    study or withdrawal of IP because other treatment options are available.
    The Investigator is responsible for ensuring that consideration has been given to the poststudy
    care of the participant’s medical condition.
    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 Decision2018-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-06
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