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    Summary
    EudraCT Number:2017-003627-30
    Sponsor's Protocol Code Number:20170367744
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-01
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-003627-30
    A.3Full title of the trial
    Protection from food induced anaphylaxis by reducing serum level of specific IgE
    Beskyttelse mod fødevareinduceret anafylaksi ved reduktion af
    specifikt serum IgE overfor fødevaren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protection from food induced anaphylaxis by reducing serum level of specific IgE
    Beskyttelse mod fødevareinduceret anafylaksi ved reduktion af
    specifikt serum IgE overfor fødevaren.
    A.3.2Name or abbreviated title of the trial where available
    Protana
    Protana
    A.4.1Sponsor's protocol code number20170367744
    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 SponsorOdense Research Center for Anaphylaxis (ORCA)
    B.1.3.4CountryDenmark
    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 supportORCA
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Research Center of Anaphylaxis (ORCA)
    B.5.2Functional name of contact pointCarsten Bindslev-Jensen
    B.5.3 Address:
    B.5.3.1Street AddressKløvervænget 15
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post codeDK-5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004565413624
    B.5.6E-mailcarsten.bindslev-jensen@rsyd.dk
    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
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Food Allergy with Anaphylaxis
    Fødevareallergi med anafylaksi
    E.1.1.1Medical condition in easily understood language
    Food Allergy with severe symptoms
    Fødevareallergi med alvorlige symptomer
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014315
    E.1.2Term Egg allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016709
    E.1.2Term Fish allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040539
    E.1.2Term Shellfish allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001745
    E.1.2Term Allergy to cow's milk
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10034202
    E.1.2Term Peanut allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027024
    E.1.2Term Meat allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011240
    E.1.2Term Cow's milk allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054957
    E.1.2Term Allergy to grains
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054959
    E.1.2Term Allergy to nuts
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064075
    E.1.2Term Seafood allergy
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076438
    E.1.2Term Milk protein allergy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim will be to investigate if the combination of initial IgE-specific immunoadsorption and subsequent therapy with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies in patients with food anaphylaxis.
    At undersøge om en kombination af fjernelse af specifikt IgE ved immunabsorption og efterfølgende behandling med lægemidlet Omalizumab (Xolair) vil øge den kliniske tærskelværdi for en ikke-tålt fødevare hos patienter med fødevareudløst anafylaksi.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 10 male or female subjects, age 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included.
    •10 mænd eller kvinder i alderen fra 18 år til 70 år
    •Diagnostiseret allergi overfor en fødevare, fx mælk, æg, peanut, hasselnød, sesam, hvede, torsk, reje, hvor specifik IgE bestemmes ved valideret analysemetode. Patienter med/uden forhøjet niveau af total IgE (> 1000 kIU/l), vil kunne inkluderes, hvis minimumniveauet af specifik IgE for det ikke-tålte allergen er større eller lig med 10 kIU/l. Der er ingen kontrolgruppe.
    E.4Principal exclusion criteria
    •Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient’s safety or study outcomes.
    •Infection on the day of study
    •Pregnancy or nursing
    •Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests
    •Ongoing treatment with β-blockers that cannot be paused one day prior to the tests
    •Ongoing treatment with oral glucocorticoids (>10 mg daily)
    •Alcohol abuse, abuse of opioids or other drugs
    •Occurrence of unexpected side effects
    •Patients who are not supposed to be able to meet the requirements in the protocol
    •Patients who are physically or mentally unable to consent
    •Iskæmisk hjertesygdom eller anden alvorlig sygdom (fx ukontrolleret astma)
    •Infektion på forsøgsdagene
    •Gravide eller ammende. Kvinder i den fødedygtige alder skal anvende sikker prævention
    •Misbrug af alkohol, lægemidler, narkotika inden for det sidste år
    •Blodprøver, der ligger uden for normalværdien på screeningstidspunktet
    •Må ikke samtidig indtage:
    oBehandling med antihistamin, som ikke kan pauseres i 3 dage før testning
    være i behandling med ß-blokerende lægemidler, som ikke kan pauseres 1 dag før testning i systemisk steroidbehandling (>10 mg daglig)
    •Ved forekomst af uventede bivirkninger
    •Patienter, der ikke er i stand til at overholde krav i protokollen (fx glemmer at møde til aftalt tid)
    •Patienter, der ikke er fysisk eller psykisk i stand til samarbejde
    E.5 End points
    E.5.1Primary end point(s)
    Primary parameters: Clinical thresholds before, during and after therapy (Tr0, TrP, TrX and TrW) will be determined for each patient as described. Serum levels of total and specific IgE together with skin prick test and basophil histamine release test will be determined at the time points described.
    Since clinical threshold values may fluctuate spontaneously over time, only a change exceeding 1 challenge step will be considered clinically significant. Since the theoretical maximal efficacy of the combined therapy is a forty fold increase in threshold (a factor of 10 by plasmapheresis and a factor of at least 4 by Omalizumab 300 mg) the expected change from Tr0 to TrX will be at least a factor of 10, corresponding to at least two dose steps. No difference between Tr0 (before therapy) and TrW (four weeks after cessation of therapy is expected, although an effect on lymphocytic B-cells after repeated immunoadsorption has been suggested.
    Det forventes at se en øgning på ca. 40 gange af tærskelværdien for, hvor meget patienten kan spise af den ikke-tålte fødevare, før allergiske symptomer viser sig, fra udgangspunkt (Tr0) til tærskelværdien efter begge behandlinger (faktor 10 efter immunadsorption og faktor 4 efter Omalizumab). Derimod forventes ingen forskel i tærskelværdierne fra Tr0 til 4 uger efter afsluttede behandlinger (TrW), hvor IgE mængden er gendannet.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    ikke relevant
    E.5.2Secondary end point(s)
    The reduction in total IgE as well as the reduction of the levels of specific IgE to the major components of the allergen will be correlated to the corresponding thresholds. An inverse correlation is expected. Reduction in SPT size and a shift to the right of basophil histamine release is also expected.
    Tilsvarende med hensyn til de øvrige test, blodprøvemålinger for total og specifik IgE og histaminfrigørelse og hudpriktest.
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    ikke relevant
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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
    LVLS
    sidste besøg, sidste patient
    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 months
    E.8.9.1In the Member State concerned days
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 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 state10
    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)
    Continued treatment with Omalizumab (Xolair) after the trial has finished will not be offered inside the trial.
    Efter forsøget afslutning tilbydes ikke fortsat behandling med Omalizumab. Der gives ikke anden medicin under forsøget, bortset fra en adrenalin autoinjector til fødevareallergiske patienter.
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-27
    P. End of Trial
    P.End of Trial StatusOngoing
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