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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-004427-37
    Sponsor's Protocol Code Number:5421234
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-004427-37
    A.3Full title of the trial
    Treatment with Omalizumab in food allergic children
    Behandling af børn med førevareallergi med Omalizumab (Xolair)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Omalizumab in food allergic children
    Behandling af børn med førevareallergi med Omalizumab (Xolair)
    A.3.2Name or abbreviated title of the trial where available
    TOFAC
    TOFAC
    A.4.1Sponsor's protocol code number5421234
    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 Centre 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 supportOdense Research Centre for Anaphylaxis (ORCA)
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Research Centre for Anaphylaxis (ORCA)
    B.5.2Functional name of contact pointAllergy Center
    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 number0045 65413621
    B.5.6E-maillouise.parke@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 Limited
    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.3.9.3Other descriptive nameXolair
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75 to 600
    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 placeboInjection
    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
    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 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 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 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 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
    1.To evaluate the efficacy of Omalizumab on food allergy thresholds in children.
    1. At undersøge hvor meget 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
    2.To evaluate if skin prick test (SPT), specific IgE (s-IgE), total-IgE (t-IgE), Histamine release (HR) test, Basophil Activation Test (BAT) and specific IgG4 to culprit foods can be used as predictors for the effect of Omalizumab.
    3.To evaluate the efficacy of Omalizumab on comorbidity severity and Quality of Life (QoL).
    2. At undersøge om ændringer i patientens allergiblodprøveværdier og hudpriktest kan anvendes til at forudsige effekten af Omalizumab
    3. At undersøge effekten af behandling med Omalizumab på patientens øvrige allergisk sygdommeog på livskvalitet (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    100 children between 6 and 18 years with a clinical diagnosis of food allergy to ≥1 food allergen, including a positive skin prick test (SPT) (mean wheal diameter > 3mm), specific IgE (s-IgE) > 0.35 kIU/l to the allergen in question, and a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC) (Table 2). If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of specific IgE and when available challenge results within the last year) will be used.
    •100 patienter mellem 6 og 18 år
    •have allergi overfor mindst en fødevare fx æg, mælk, sesam, torsk, rejer, peanut, hasselnød og/eller hvede, diagnosticeret ved en hudpriktest (nældefeberknop med diameter > 3mm), en positiv fødevareprovokation med en tærskelværdi, der er under eller lig med 300 mg protein (443 mg kumulativ) og en blodprøvemåling på specifik IgE > 0.35 kIU/l. Hvis patienten har fødevareallergi overfor flere end en fødevare testes på den fødevare, hvor patienten har lavest tærskelværdi
    •må ikke indtage fødevaren, der ikke tåles under forsøget
    •bære en adrenalin-pen på sig hele tiden under forsøget og kunne anvende den
    E.4Principal exclusion criteria
    •Total IgE >1500 kU/L
    •Significant co-morbidity that might compromise the patient’s safety or study outcomes
    •Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken.
    •Ongoing treatment with antihistamine or drugs with antihistaminic effect
    •Ongoing treatment with β-blockers and ACE-inhibitors
    •Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
    •Alcohol abuse, abuse of opioids or other drugs in adolescents
    •Patients/parents who are not supposed to be able to meet the requirements in the protocol
    •Patients/parents who are physically or mentally unable to consent
    •Occurrence of unexpected side effects
    •Patients who have reduced liver function or kidney function

    •totalt IgE >1500 kU/L
    •anden sygdom, der kan påvirke patientens helbred og sikkerhed eller forsøgsresultaterne
    •gravid eller ammende. Kvinder i den fødedygtige alder og er seksuelt aktiv skal anvende sikker prævention (homonel kontraception (p-piller) eller intrauterine device (spiral)). Sikker prævention skal anvendes under hele forsøgsperioden og i ½ år efter sidste dosis forsøgsmedicin er taget
    •formodes ikke at være i stand til at leve op til protokollen (problemer med fremmøde til planlagte besøg)
    •vanlig brug af ß-blokkere eller ACE-hæmmere
    •vanlig brug af glycokortikoid tabletter
    •vanlig brug af antihistaminer eller andre lægemidler med antihistamininerg effekt fx visse typer psykofamaka
    •har et misbrug af alkohol eller medicin/narkotika
    •har nedsat lever- eller nyrefunktion
    •forekomst af uventede bivirkninger•af fysiske eller psykiske årsager ikke er i stand til at overholde kravene i denne deltagerinformation
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo.

    Patienter, der har modtaget behandling med lægemidlet Xolair, forventes at have højere tærskelværdi over indtagelse af den ikke-tålte fødevare
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    Ikke relevant
    E.5.2Secondary end point(s)
    Secondary endpoints
    Change in challenge threshold, SPT, specific IgE, IgG4, HR test, BAT, severity of comorbidity, and quality of life at 3 and 6 months and from 0 to 6 months of treatment within and between the groups.
    Our hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold.

    Within the groups:
    •3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in asthma dose – in primary responders
    •3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment with Omalizumab in max dose – in primary non-responders
    •3 months treatment with placebo versus 6 months with placebo – in primary placebo-responders
    •3 months treatment with placebo versus 3 months with max dose Omalizumab – placebo cross over to active

    Between the groups:
    •3 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab
    •6 months treatment with Omalizumab in asthma dose versus 3 months with max dose Omalizumab
    Fødevareallergiske patienter og deres pårørende forventes at skulle være mindre bekymrede for, at de fejlagtigt indtager fødevarer med spor af den fødevare, som vedkommende ikke kan tåle og dermed opnå en betydelig forøget livskvalitet.
    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 No
    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 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 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 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
    LVLS
    Sidste patient, sidste besøg
    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 months9
    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 Yes
    F.1.1Number of subjects for this age range: 100
    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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    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
    Parents of patients under the age of 15 years respond to the patient's behalf
    Forældre til patienter under 15 år svarer på patientens vegne
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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
    ingen
    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 Decision2019-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
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