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    Summary
    EudraCT Number:2016-003369-24
    Sponsor's Protocol Code Number:ILIT-3L
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-003369-24
    A.3Full title of the trial
    Double-blind randomised controlled study to down regulate allergic responses in adults with allergic rhinoconjunctivitis by using three intralymphatic injections of grass and birch allergen or placebo one month in between during the non-seasonal period.
    Dubbelblind randomiserad kontrollerad studie avseende nedreglering av allergisvar hos vuxna med allergisk rinokonjunktivit genom att använda tre intralymfatiska injektioner av gräs- och björkallergen eller placebo med en månads mellanrum under icke-pollenperiod.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A treatment study of 44 adult persons with injection of grass- and birch pollen in a lymph nodule with one month in between - for treatment of pollen allergy.
    Behandling av 44 vuxna som har pollenallergi med tre injektioner av gräs- och björkallergen i en lymfkörtel med en månads mellanrum.
    A.3.2Name or abbreviated title of the trial where available
    ILIT-3 - trial to down regulate allergy by IntraLymphatic allergen ImmunoTherapy
    ILIT-3 - studie för att nedreglera allergi med IntraLymfatisk ImmunTerapi
    A.4.1Sponsor's protocol code numberILIT-3L
    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 SponsorAllergy Centre
    B.1.3.4CountrySweden
    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 supportFORSS, ALF, Asthma and Allergy Association, Konsul TH Bergs stiftelse, Hesselman foundation
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergy Centre
    B.5.2Functional name of contact pointLennart Nilsson
    B.5.3 Address:
    B.5.3.1Street AddressAllergy Centre
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46101034781
    B.5.5Fax number+46101034773
    B.5.6E-maillennart.j.nilsson@regionostergotland.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 ALK-Alutard SQ Betula verrucosa (R)
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abello
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameALK-Alutard SQ Betula verrucosa (R)
    D.3.2Product code VO1AA05
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ALK-Alutard SQ 5-grasses
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abello
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameALK-Alutard SQ 5-grasses
    D.3.2Product code VO1AA02
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    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 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 placeboIntralymphatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic rhinoconjunctivitis
    Allergisk rinokonjunktivit
    E.1.1.1Medical condition in easily understood language
    Hay fever
    Pollensnuva
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Symptoms and medicine consumption via the "Combined Symptom and Medication Score" (CSMS) that combines "Rhinoconjunctivitis Total Symptom Score" (RTSS) and the rhinitis "Medication Score" (MS). CSMS will be evaluated daily during the season before treatment and will be compared with the following pollen season after treatment and with placebo. The patients will use a mobile app for their responses.

    Effects on quality of Life (QoL), measured every other week for the season before the treatment and after the following pollen season using the "Rhinoconjunctivitis Quality of Life Questionnaire" (RQLQ).
    Symtom och medicinkonsumtion via "Combined Symptom and Medication Score" (CSMS) som är en kombination av symtomen från frågeformuläret "Rhinoconjunctivitis Total Symptom Score (RTSS)" och användandet av allergimediciner (MS). CSMS bedöms dagligen under pollensäsongen före behandling och jämförs med den följande pollensäsongen efter behandling och med placebo. Patienterna kommer att använda en mobil app för sina bedömningar av symtom.

    Effekt på livskvalitet (QoL), mätt säsongen före behandling varannan vecka och den följande pollensäsongen genom att använda "Rhinoconjunctivitis Quality of Life Questionnaire" (RQLQ).
    E.2.2Secondary objectives of the trial
    Evaluation of the generic questionnaire,RAND-36, every other week during the pollen season before and after treatment.

    CDsens before treatment and during the autumn after treatment.

    Skin prick test reactions, specific IgE, inflammatory mediators and cell-mediated immunity in blood after the pollen season after treatment compared with pre-treatment.

    Safety variables: Registration of adverse events from the time of the first injection to 1 year after the last injection will be recorded for all patients. Also, control of Hb, leucocytes, differential count of leucocytes, transaminases and creatinine will be done before treatment and at the end of the study.

    After the placebo-controlled study is over in January 2019, we will continue follow the subjects in an open study for safety evaluation with a telephone call every year as well as the RQLQ questions for the two pollen seasons each year to 2015.
    Utvärdering av besvärsgrad med det generiska frågeformuläret, RAND-36, varannan vecka under pollensäsongen före behandling jämfört med pollensäsongen efter behandling.

    CDsens före behandling och under hösten efter behandling.

    Pricktestreaktioner, analys av specifikt IgE, inflammatoriska mediatorer samt cellmedierad immunitet i blodanalyser efter den nästkommande pollensäsongen efter behandling jämfört med innan behandling.

    Säkerhetsvariabler: Registrering av oväntade händelser från tiden för första injektionen till ett år efter sista injektionen för alla patienterna. Dessutom, kontroll av Hb, vita, diff, transaminaser och kreatinin görs innan behandling, efter behandling och vid slutet av studien.

    Efter det att den placebo-kontrollerade studien är slut januari 2019, kommer vi att följa forskningspersonerna i en öppen studie för säkerhetsutvärdering med ett teleonsamtal varje år liksom med livskvalitetfrågeformuläret RQLQ för de två pollensäsongerna varje år till 2025.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-55 years.
    Seasonal moderate to severe allergic symptoms for grass and birch during the two latest seasons.
    Positive skin prick test and/or positive serum-IgE to birch and timothy.
    Retrospective symptoms measured as RTSS >= 8.
    Accepted and signed informed consent.
    18-55 års ålder.
    Allergiska pollensymtom av måttlig till svår grad på grund av björk och timotej under de senaste två pollensäsongerna.
    Positiv pricktest eller positiv serum-IgE mot björk och timotej.
    Retrospektiva symtom mätta med RTSS på mer än eller lika med 8.
    Underskrivet informerat samtycke
    E.4Principal exclusion criteria
    The presence of any of the following will exclude the potential study patient from entry into the study and will exclude the patient for the ILIT injections at visits 3, 4 and 5:

    Pregnancy or nursing, or planning for that November 2017 until March 2018. Women with childbearing potential should use contraceptives. Condom only is not enough as contraceptive.
    Adequate anticonception:

    - Oral contraceptive, either combined or progestogen alone,
    - Injectable progestogen,
    - Implants or etenogestrel or levonogestrel,
    - Sterilisation done by the fertile woman, or male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
    a. Also, has practiced adequate contraception for 30 days prior to the first ILIT injection
    b. Has a negative pregnancy test on the day of vaccination
    c. Has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

    Autoimmune or collagen disease
    Known cardiovascular disease, i.e. not even NYHA class I.
    Use of ACE-blockers. If ACE-blockers are used, they should be withdrawn after discussion with the Principal Investigator 2 weeks before first injection until 2 weeks after last injection
    Pulmonary disease with FEV1 < 75 % of predicted
    Pulmonary disease, perennial or seasonal with daily use of more than 800 microgram inhalated budesonide/ day (or equivalent) or treatment with omalizumab.
    Unstable asthma, decided by the investigator or >12% reversibility in FEV1 in visit 2.
    Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment.
    Allergic reaction last 3-4 days or anaphylaxia last month before ILIT injections. Vaccination of any kind two weeks before to two weeks after the three times of ILIT injections.
    Recent or on-going hepatic disease
    Recent or on-going renal disease
    All tumour diseases without non-melanoma skin cancers or in situ cervix cancer Increased bleeding tendency with or without abnormal platelets, PK-INR or APTT.
    Any other than study medication with an effect of interfering with the immune response
    Immuno- or chemotherapy last 15 years
    Upper airway disease (non-allergic sinusitis, nasal polyps)
    Depot steroid injection for treatment of allergic rhinoconjunctivitis
    Chronic obstructive or restrictive lung disease
    Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with beta-blockers)
    Major metabolic disease
    Known or suspected allergy to additives to the study product
    Skin diseases with barrier defect in the inguinal areas
    Alcohol, drug abuse or tobacco smoking
    Mental incapability of coping with the study
    Participation in another clinical study from visit one until last patient has been evaluated after the pollen season after treatment. Studies with pharmacological agents or studies that could otherwise disturb the study are not permitted after the first evaluation of the study.
    Om något av följande föreligger exkluderas patienten ur studien och patienten exkluderas från ILIT-injektioner vid besök 3, 4 och 5:

    Graviditet eller amning, eller planerande för graviditet under perioden November 2017 - Mars 2018. Kvinnor i fertil ålder skall använda antikonceptionsmedel. Kondom är inte tillfyllest som antikonceptionsmedel. Adekvat antikonception:
    - Oralt preventivmedel, antingen kombinationspreparat eller progesteron
    - Injicerat progesteron
    - Implantat för antikonception
    - Sterilisering av den fertila kvinnan, eller dennas manliga partner om denne har steriliserat sig innan studien och är den ende sexuella partnern för kvinnan
    a, Dessutom om kvinnan har använt adekvat kontraception i 30 dagar innan den första ILIT-injektionen
    b, Har en negativ graviditetstest på dagen för vaccination
    c, Har godkänt att fortsätta adekvat kontraception under hela behandlingsperioden och i två månader efter avslutad vaccinatiosserie

    Autoimmun eller kollagen sjukdom.
    Känd kardiovaskulär sjukdom, vilket innebär uteslutande även av NYHA klass I. ACE-hämmare. Om ACE-hämmare används ska detta uteslutas efter diskussion med prövningsledare, 2 veckor före första injektionen till 2 veckor efter sista injektionen
    Lungsjukdom med FEV1 <75% av förväntat
    Lungsjukdom, perenn eller under säsongs, med dagligt användande av >800 mikrogram inhalerat budesonid/dag (eller ekvivalent dos) eller behandling med omalizumab
    Instabil astma, beslutat av prövningsledare, eller >12% reversibilitet i FEV1 vid besök 2.
    Samtidig infektion med feber eller andra tecken/symtom av en akut eller kronisk infektion vid behandling
    Allergisk reaktion senaste 3-4 dagarna eller anafylaxi senaste månaden innan ILIT-injektionerna
    Vaccination av ngt vaccin en månad före till en månad efter de tre gångerna som ILIT-injektioner ges
    Nylig eller pågående leversjukdom
    Nylig eller pågående njursjukdom
    Alla tumörsjukdomar förutom icke-melanoma hudmaligniteter eller in situ cervixcancer
    Ökad blödningstendens med eller utan abnormala trombocyter, PK-INR eller APTT
    Någon annan än studiemedicinen med en effekt som interferar med immunsvar Immun- eller kemoterapi senaste 15 åren
    Övre luftvägssjukdom (icke-allergisk sinuit, nasal polyp)
    Depot steroidinjektion för behandling av allergisk rinokonjunktivit
    Kronisk obstruktiv eller restriktiv lungsjukdom
    Sjukdom eller förhållande som kan påverka behandlingen av anafylaktisk reaktion (symptomatisk koronarkärlssjukdom, svår arteriell hypertension och behandling med betablockerare
    Metabolisk sjukdom av allvarligare grad
    Känd eller misstänkt allergi mot tillsatser i studieprodukten
    Hudsjukdomar med barriärdefekt i ljumskområdena
    Alkohol, drogmissbruk eller tobaksrökning
    Mental oförmåga att kunna medverka i studien
    Deltagande i någon annan klinisk studie från besök 1 till sista patient har evaluerats efter pollensäsongen efter studiebehandling. Studie med läkemedel eller studier som på annat vis skulle kunna störa studien är inte heller tillåtna efter den första evalueringen av studien.
    E.5 End points
    E.5.1Primary end point(s)
    Symptoms and medicine consumption via a combined short questionnaire (CSMS) consisting of "Rhinoconjunctivitis Total Symptom Score" (RTSS) and use of rhinitis medication (MS) will be used via a daily electronic app and evaluated during the pollen season before treatment and compared with the the following pollen season after treatment.

    Effects on quality of life measured every second week during the pollen season before the treatment and after the next pollen season using the "Rhinoconjunctivis Quality of Life Questionnaire" (RQLQ).
    Symtom och medicinkonsumtion via ett kombinerat kort frågeformulär(CSMS) som inbegriper "Rhinoconjunctivitis Total Symptom Score" (RTSS) och användande av allergimediciner (MS) vilket utvärderas med en dagligen använd app under pollensäsongen innan behandlingen och under den följande pollensäsongen.

    Effekt på livskvalitet (QoL), mätt varannan vecka säsongen före behandling och efter nästa pollensäsong genom att använda "Rhinoconjunctivis Quality of Life Questionnaire" (RQLQ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    See above
    Se ovan
    E.5.2Secondary end point(s)
    A generic questionnaire, RAND-36, will be answered once a month during the two pollen seasons in the study.

    CDsens before and after treatment.

    Skin prick reactions, specific IgE och IgG4, inflammatory mediators and cel-mediated immunity in blood after the first and next pollen season after treatment compared with pre-treatment.

    Safety variables: Registration of adverse events from the time of the first injection to 1 year after the last injection has been given to all patients. Also, control of Hb, leucocytes, differential count of leucocytes, transaminases and creatinine wil be done before the treatment, after the treatment and at the end of the study.
    Ett generiskt frågeformulär, RAND-36, som besvaras var månad under de två pollensäsongerna i studien.

    CDsens före och efter behandling.

    Pricktestreaktioner, analys av specifikt IgE och IgG4, inflammatoriska mediatorer samt cellmedierad immunitet efter den första pollensäsongen och under nästa pollensäsong efter behandling jämfört med innan behandling.

    Säkerhetsvariabler: Registrering av oväntade händelser från tiden av första injektionen till ett år efter sista injektionen har givits till alla patienterna. Dessutom, kontroll av Hb, vita, diff, transaminaser och kreatinin görs innan behandling, efter behandling och vid slutet av studien
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    Se ovan
    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 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) 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 for Last Patient
    Sista besöket för sista patienten
    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 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: 44
    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 state44
    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)
    Routine care according to general practice
    Rutinomhändertagande enligt gängse praxis
    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 Decision2016-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-11-16
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