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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2015-000276-10
    Sponsor's Protocol Code Number:FAST2015
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-000276-10
    A.3Full title of the trial
    FAST – Food Allergy Specific ImmunoTherapy
    A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish
    W kierunku bezpiecznej i skutecznej immunoterapii przewlekłych, zagrażających życiu alergii pokarmowych. Immunoterapia Swoista Alergii Pokarmowej (FAST).
    Międzynarodowe badanie II fazy mające na celu ocenę skuteczności i bezpieczeństwa podskórnej immunoterapii zmodyfikowanym alergenem ryby – parwalbuminą podawaną w rosnących dawkach i leczeniu podtrzymującym u pacjentów uczulonych na ryby.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FAST- Allergy vaccination for patients with fish allergy for the treatment of fish allergy
    W kierunku bezpiecznej i skutecznej immunoterapii przewlekłych, zagrażających życiu alergii pokarmowych (FAST).
    A.3.2Name or abbreviated title of the trial where available
    FAST2015
    FAST2015
    A.4.1Sponsor's protocol code numberFAST2015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02382718
    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 SponsorAcademisch Medisch Centrum bij de Universiteit van Amsterdam (AMC) Prof. dr. M. M. Levi, Dean & Chair
    B.1.3.4CountryNetherlands
    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 supportEU 7.th Framework Programme
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergy Dpt, 2nd Pediatric Clinic, University of Athens
    B.5.2Functional name of contact pointClinical Coordinator FAST2015
    B.5.3 Address:
    B.5.3.1Street Address41, Fidippidou
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code115 27
    B.5.3.4CountryGreece
    B.5.4Telephone number+306945312488
    B.5.6E-mailstjorge@otenet.gr
    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 nameFAST fish mCyp c 1
    D.3.4Pharmaceutical form Suspension 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 INNMCYP C 1
    D.3.9.2Current sponsor codeORG28081
    D.3.9.3Other descriptive nameMCYP C 1
    D.3.9.4EV Substance CodeSUB178826
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.00015
    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 placeboSuspension 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
    Food allergy to fish
    Alergia pokarmowa na rybę
    E.1.1.1Medical condition in easily understood language
    Food allergy to fish
    Alergia pokarmowa na rybę
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a SCIT (subcutaneous immunotherapy)-treatment with a mutant recombinant fish-parvalbumin (mCyp c1, carp parvalbumin) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.
    Ocena skuteczności SCIT (podskórnej immunoterapii) zmutowaną rekombinowaną parwalbuminą ryby (mCyp c1, parwalbumina karpia) u osób z alergią na rybę.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of SCIT treatment with mCyp c 1 and determine any possible changes in the severity of the reaction during the pre- and post-treatment DBPCFC (double blind placebo controled food challenge) with fish, in the SPT (skin prick test) reactivity to fish, in specific IgE, IgA, IgG, IgG4 antibodies against fish and rCyp c 1 (recombinant carp parvalbumin) and in the biological activity of IgE, between the active and placebo study groups.
    Ocena bezpieczeństwa terapii SCIT z mCyp c1 i ocena możliwych zmian w ciężkości reakcji podczas podwójnie ślepej kontrolowanej placebo próby prowokacyjnej z rybą (DBPCFC) wykonanej przed leczeniem i po leczeniu, zmian reaktywności skóry w testach skórnych z rybą, w stężeniu swoistych przeciwciał IgE, IgA, IgG4 przeciwko rybie i rCyp c1 (rekombinowana parwalbumina karpia) oraz w aktywności biologicznej IgE między grupami badanych otrzymujących aktywną substancję i placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject having given a written informed consent before completing any study related procedure.
    Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
    For woman of child bearing potential:
    -a negative urine pregnancy test at screening visit,
    -the subject must receive/ use a medically effective contraceptive method during the study.
    Convincing case history of allergy (immediate allergic reaction ≤ 2 hours) to fish ingestion.
    Specific IgE to fish by both a positive (3mm mean wheal diameter over negative control) SPT to cod extract and an ImmunoCAP ≥ class 2 (0.70 kUA/L) for cod (f3) and rCyp c 1 at screening.
    Positive DBPCFC with cod at screening visits.
    Spirometry FEV1 ≥ 80% of predicted values at screening.
    Subject accepting to comply fully with the protocol.
    • wyrażenie pisemnej, świadomej zgody na udział w badaniu
    • płeć męska lub żeńska, wiek 18-65 lat,
    • dobry stan zdrowia określony na podstawie wywiadu lekarskiego oraz badania fizykalnego
    • u kobiet w wieku rozrodczym: negatywny test ciążowy na wizycie skrinigowej i skuteczna antykoncepcja podczas badania
    • przekonywujący wywiad reakcji natychmiastowej (do 2 godzin) po spożyciu ryby
    • obecność swoistych IgE na rybę: dodatni test skórny z wyciągiem z dorsza (3mm średnica bąbla powyżej negatywnej kontroli) oraz ImmunoCAP ≥ klasa 2 (0,70kUA/L) w teście z dorszem (f3) i rCyp c1 na wizycie skriningowej.
    • dodatnia podwójnie ślepa kontrolowana placebo próba prowokacyjna z dorszem na wizytach skriningowych
    • w spirometrii spoczynkowej FEV1 ≥80% wartości należnych na wizycie skriningowej
    • pełna akceptacja protokołu
    E.4Principal exclusion criteria
    Placebo-reaction in DBPCFC.
    Reaction in the last (7th) dose of the DBPCFC.
    Food anaphylaxis: anaphylactic shock (a score of 2 or 3 on cardiovascular/ neurologic symptoms according to PRACTALL (1): score 2 = drop in blood pressure and/or >20% from baseline, or significant change in mental status- score 3 = cardiovascular collapse, signs of impaired circulation/ unconscious) due to fish intake, both during the past and at screening DBPCFC.
    Ongoing immunotherapy (IT) with any kind of allergen.
    Ongoing or previous treatment with omalizumab.
    Any clinical condition that contraindicates IT (EAACI guidelines) (8): serious immunological diseases, major cardiovascular disease, cancer, chronic infections, lack of compliance and severe psychological disorders.
    Any significant clinical condition that the investigators judged might hamper the patient’s safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, mental disease, immunological and endocrine disease.
    Chronic urticaria.
    Severe atopic dermatitis or non-controlled atopic dermatitis.
    Ongoing treatment with betablockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor II antagonists (ARA II).
    Pregnancy or nursing.
    Uncontrolled asthma (asthma, if present, should be well controlled according to GINA guidelines using any kind of drugs except oral corticosteroids and omalizumab).
    An FEV1<80% of predicted value during screening spirometry.
    Subject who has participated in a clinical trial within 3 months prior to this one.
    Subject with a history of drug or alcohol abuse.
    Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
    Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines and/or leukotriene receptor antagonists five days prior each screening and treatment visit.
    • reakcja na placebo w podwójnie ślepej kontrolowanej placebo próbie prowokacyjnej
    • reakcja na ostatnią (siódmą) dawkę alergenu w podwójnie ślepej kontrolowanej placebo próbie prowokacyjnej
    • reakcja anafilaktyczna na pokarm: wstrząs anafilaktyczny (2 lub 3 stopień reakcji ze strony układu krążenia/układu nerwowego zgodnie z wytycznymi PRACTALL (1): po zjedzeniu ryby w przeszłości lub w czasie podwójnie ślepej, kontrolowanej placebo próby prowokacyjnej.
    • prowadzona obecnie swoista immunoterapia dowolnym alergenem
    • prowadzone obecnie lub w przeszłości leczenie omalizumabem
    • dowolna choroba, która stanowi przeciwwskazanie do immunoterapii (wg EAACI) (8): poważne choroby immunologiczne, poważna choroba układu krążenia, choroba nowotworowa, przewlekłe zakażenia, brak współpracy, poważne choroby psychiczne
    • dowolna istotna klinicznie choroba, która w ocenie badacza może pogorszyć bezpieczeństwo pacjenta i wpłynąć na przebieg i wynik badania. Do chorób tych zalicza się miedzy innymi: choroby układu krążenia, nowotwory, choroby wątroby, choroby nerek, choroby hematologiczne, neurologiczne, zaburzenia psychiczne, immunologiczne, endokrynologiczne.
    • przewlekła pokrzywka
    • ciężkie atopowe zapalenie skóry lub niekontrolowane atopowe zapalenie skóry
    • leczenie betablokerami, ACE inhibitorami, antagonistami receptora angiotensynowego
    • ciąża lub karmienie piersią
    • niekontrolowana astma
    • w spirometrii FEV1<80% wartości należnych na wizycie skriningowej
    • udział w badaniu klinicznym w czasie 3 miesięcy przed obecnym badaniem
    • uzależnienie od alkoholu lub narkotyków
    • badacze, współbadacze jak również ich dzieci i małżonkowie oraz osoby współpracujące w badaniu nie powinny być włączane
    • pacjenci z współistniejącymi w czasie badania objawami innych alergii mogą być włączeni, jeżeli nie przyjmują leków przeciwhistaminowych i/lub antyleukotrienowych pięć dni przed wizytą skriningową i każdą kolejną.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be efficacy as determined by the change from baseline in the threshold of fish protein that induces an allergic reaction. This threshold will be assessed by means of a standardized DBPCFC (double blind placebo controlled food challenge) with cod-fish after completion of six months of immunotherapy (SCIT). Success is defined as a statistically significant change in the threshold dose of protein that provokes a reaction in DBPCFC.
    Pierwszorzędowym punktem końcowym w badaniu będzie skuteczność, określona zmianą w stosunku do wartości wyjściowej, wartości progowej, czyli takiej ilości białka ryby, która wywołuje reakcję alergiczną. Wartość progowa wywołująca reakcję alergiczną będzie oszacowana podczas podwójnie ślepej kontrolowanej placebo próby prowokacyjnej z dorszem po ukończeniu sześciomiesięcznej immunoterapii.
    Sukces terapii jest określony jako istotna statystycznie zmiana wartości progowej, która wywołuje reakcje w DBPCFC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time point for each patient will be 2 weeks after the last maintenance dose of the SCIT. At that time point each patient will be subjected to a post-treatment DBPCFC.
    2 tygodnie po ostatniej podtrzymującej dawce SCIT. W tym czasie, u każdego pacjenta będzie wykonana podwójnie ślepa, kontrolowana placebo próba prowokacyjna.
    E.5.2Secondary end point(s)
    The fundamental secondary endpoint will be safety as indicated by clinical safety and tolerability and by the careful recording of adverse events; other surrogates of safety will be: physical examination, vital signs, 12-Lead ECG and laboratory evaluations (complete blood count, biochemical tests, urine analysis and urine pregnancy test).
    Secondary outcomes of efficacy are the changes from baseline in the severity of the reaction in the post DBPCFC (as compared with pre-treatment), in SPT reactivity against fish and mCyp c 1 (titrated), in serum specific IgE, IgG, IgG4 and IgA antibodies against rCyp c 1 (CAP) and in the biological activity of IgE (stripped basophil histamine release test).
    Zasadniczym drugorzędowym punktem końcowym będzie bezpieczeństwo określone przez tolerancję leczenia oraz przez dokładne raportowanie zdarzeń niepożądanych, dla oceny bezpieczeństwa będzie wykonywane badanie fizykalne, EKG i badania laboratoryjne (morfologia krwi obwodowej, testy biochemiczne, badanie moczu, test ciążowy). Drugorzędowymi miernikami skuteczności będą zmiany w ciężkości reakcji w podwójnie ślepej kontrolowanej placebo próbie prowokacyjnej, reakcji w testach skórnych oraz stężenie swoistych IgE, IgA, IgG i IgG4 oraz stężenie przeciwciał przeciwko rCyp c1 (CAP) oraz biologicznej aktywności IgE (w teście aktywacji bazofilów).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety will be monitored throughout the study.
    For efficacy, the time point for each patient will be 2 weeks after the last maintenance dose of the SCIT. At that time point each patient will be subjected to a DBPCFC. Before the food challenge patients will be subjected to blood withrawl, urine sample and skin prick tests to assess the secondary end points (both in terms of safety and efficacy).
    Bezpieczeństwo będzie monitorowane podczas badania. Skuteczność będzie oceniona 2 tygodnie po ostatniej podtrzymującej dawce SCIT. W tym czasie, u każdego pacjenta będzie wykonana podwójnie ślepa, kontrolowana placebo próba prowokacyjna. Przed prowokacją będzie pobrana krew, próbka moczu oraz zostaną wykonane testy skórne dla oceny drugorzędowych punktów końcowych (zarówno bezpieczeństwa i skuteczności).
    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 Yes
    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) 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 EEA9
    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.
    The end of the trial is defined as the time at which the last (96th) subject of the study will end treatment and 2 weeks after that will be subjected to the post-treatment evaluation (blood withdrawal, SPTs) and post-treatment DBPCFC (at two visits, visit 15A and 15B).
    Ostatnia wizyta ostatniego pacjenta.
    Zakończenie badania jest definiowane jako czas, w którym ostatni (96) pacjent zakończy leczenie i po upływie 2 tygodni zostanie poddany ocenie po zakończeniu leczenia (pobranie krwi, testy skórne) i podwójnie ślepej kontrolowanej placebo próbie prowokacyjnej (DBPCFC) (wizyta 15a i 15b).
    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 months3
    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 months3
    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: 96
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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)
    Not different from the expected normal treatment for fish allergy.
    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 Decision2015-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-31
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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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