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    Summary
    EudraCT Number:2010-020841-29
    Sponsor's Protocol Code Number:ADAPT
    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:2011-04-06
    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 number2010-020841-29
    A.3Full title of the trial
    The role of anti-IgE (omalizumab) in the management of severe
    recalcitrant paediatric atopic eczema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to see if anti-IgE (an antibody) will improve severe eczema that has not been cured by other types of medicine
    A.3.2Name or abbreviated title of the trial where available
    Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT)
    A.4.1Sponsor's protocol code numberADAPT
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN15090567
    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 SponsorKing`s College London
    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 supportGuy's and St Thomas' charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy`s & St Thomas` NHS Foundation Trust
    B.5.2Functional name of contact pointSusan Chan
    B.5.3 Address:
    B.5.3.1Street AddressSt Thomas' Hospital
    B.5.3.2Town/ cityWestminster Bride Raod, London
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071889730
    B.5.5Fax number+4402071889782
    B.5.6E-mailsusan.chan@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy`s & St Thomas` NHS Foundation Trust
    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 supportGuy's and St Thomas' Charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy`s & St Thomas` NHS Foundation Trust
    B.5.2Functional name of contact pointDr Susan Chan
    B.5.3 Address:
    B.5.3.1Street AddressSt Thomas' Hospital
    B.5.3.2Town/ cityWestminster Bridge Road, London
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071889730
    B.5.5Fax number+4402071889782
    B.5.6E-mailsusan.chan@kcl.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 Yes
    D.2.1.1.1Trade name Xolair
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOmalizumab (Xolair)
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmalizumab
    D.3.9.1CAS number 242138-07-4
    D.3.9.3Other descriptive nameXolair
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe eczema in children
    E.1.1.1Medical condition in easily understood language
    Severe eczema in children
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.2Term Atopic eczema
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10014189
    E.1.2Term Eczema allergic atopic
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our hypothesis is that anti-IgE is associated with an improvement in eczema severity, compared to placebo.
    E.2.2Secondary objectives of the trial
    Primary outcome measure
    1.Eczema severity:assessed by validated eczema score,objective SCORAD after 24 weeks treatment.
    Secondary outcome
    1.Treatment failure: patients who after 12 weeks treatment have persistent severe eczema despite 2 courses of rescue therapy
    2.Alternative systemic therapy: patients in whom
    a)alternative systemic therapy has started as a result of treatment
    failure(defined above)
    OR
    b)alternative systemic therapy is started after 12 weeks and by 30 weeks.
    3.Eczema quality of life by questionnaire
    4.Eczema severity: objective & subjective SCORAD & EASI assessments, measurements of TEWL & medical photography
    5.Effect on co-existing allergic disease by questionnaire(PADQLQ)
    6.Adverse events
    7.Number of eczema exacerbations
    8.Infective episodes of eczema
    9 a)Change in free total IgE and allergen specific IgE
    b)the change in reactivity to food and aeroallergens
    10. Change in use of potent topical steriods &calcineurin inhibitors
    11.Mechanism action of anti-IgE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The inclusion criteria for run-in are:
    1. Children between the ages of 4-19 years at the time of enrolment
    2. Severe eczema with
    i.an objective SCORAD (a validated eczema severity score) of over 40
    ii.in a patient unresponsive to optimal topical therapy (potent topical
    steroids and topical calcineurin inhibitors) or systemic therapy.
    iii.in whom there is no impression of lack of compliance
    iv.with a (C)DLQI score of ≥10
    v.and in whom active skin infection has been ruled out and/or adequately
    treated
    3. Raised SpIgE (>0.35 IU/ml)or SPT (>3mm)to at least 1 food allergen
    or 1 aeroallergen
    AND/OR
    4. Clinical impression that allergic exposures cause worsening eczema.
    5. Total IgE level >300 kU/l.
    6. Clinically proven IgE-mediated allergic disease including at least 1 of
    the following:
    i) immediate hypersensitivity to a food as proven by raised specific
    IgE (SpIgE) or skin prick test (SPT) greater than the 95% positive
    predictive value or ≥8mm, or a positive double blind placebo controlled
    food challenge,
    ii) allergic rhinoconjunctivitis as defined by sensitisation to a
    respiratory allergen and clinical history of rhinoconjunctivitis symptoms
    when exposed to the relevant allergen
    iii) allergic asthma: a history of cough, wheeze, or shortness of breath
    that
    (1) was responsive to therapy with bronchodilators on two or
    more occasions in the previous 24 months,
    (2) required one visit to a physician in the previous 24 months,
    and
    (3) occurred during the night, during early morning, or upon
    exercising in the intervals between exacerbations at any time in the
    previous 12 months and
    (4) where allergic exacerbations can be clinically related to an
    allergen exposure WITH a corresponding positive SPT or SpIgE to
    allergen.
    7. Written informed consent to participate.
    E.4Principal exclusion criteria
    1. Children and/or families who are unable to comply with the regime of
    2-4 weekly injections and clinic visits
    2. Evidence of underlying immune compromise, autioimmune disease,
    immune complex mediated conditions.
    3. Malignancy or a history of malignancy.
    4. Known cardiovascular or ischaemic cerebrovascular abnormality.
    5 Other serious or uncontrolled systemic disease.
    6. Pregnancy or lactation.
    7. Known history of hypersensitivity or anaphylaxis to anti-IgE injections
    or its constituents.
    8. Insufficient understanding of the trial assessments.
    9. Participation in a CTIMP in the previous 60 days or (if known) 4 halflives
    of the relevant medication, whichever is the greater. In this case,
    entry may be delayed until the appropriate time.
    10. Investigator feels that there is a good clinical reason why the child
    would be unsuitable to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    SCORAD (objective eczema severity score) at the end of 24 weeks of treatment with anti-IgE or placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    1. Treatment failure: patients who, after the 1st 12 weeks of treatment, have persistent severe eczema despite 2 courses of rescue therapy (0.5 to 1mg/kg/day of oral prednisolone for a week at a maximum dose of 40mg/day, followed by a week at 50% of this dose)
    2. Alternative systemic therapy: in patients whom:
    a) alternative systemic therapy has been started as a result of treatment failure as defined above, or
    b) where alternative systemic therapy is started after 12 weeks and by 30 weeks.
    3. Eczema quality of life: by questionnaire: POEM, (C)DLQI
    4. Eczema severity by objective and subjective SCORAD and EASI (Eczema Area
    and Severity Index) assessments, measurements of transepidermal water loss (TEWL) and
    medical photography.
    5. Effect on co-existing allergic disease by questionnaire (PADQLQ)
    6. Adverse events: by history and investigations
    7. Number of eczema exacerbations
    8. Infective episodes of eczema
    9 a) Change in free total IgE and allergen specific IgE
    b) the change in reactivity to food and aeroallergens: by skin prick tests.
    10. Change in use of potent topical steroids and calcineurin inhibitors: the weight, extent
    and frequency of use will be recorded at each visit.
    11. Mechanism of action of anti-IgE (this study will enable us to store the samples required
    to study the immunohistochemical changes and the immunomodulatory effects on allergenspecific
    T cells and FAP. There will also be an option to store blood for genetic studies.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. All visits
    2. All visits
    3. 0, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks
    4. SCORAD and EASI assessments will be used to examine eczema severity before and during treatment, and at 36 and 48 week post treatment reviews. Optional Measurements of transepidermal water loss (TEWL) will be performed at baseline, and at 24, 36 and 48 week (post treatment) reviews. Medical photography will also be used to record the condition of eczema at baseline and after 24 weeks of treatment.
    5. 0, 16, 28, 36, 48 weeks
    6. Throughout trial
    7. At each visit
    8. At each visit
    9. 0, 24 weeks
    10. At each visit
    11. 0, 24 weeks
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.5The 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 Yes
    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 patient
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 62
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 62
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 62
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects under age incapable of giving consent personally
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state62
    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)
    local NHS treatment will be sought.
    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 Decision2011-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-31
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