A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis (TreeTop)

January 20, 2025 updated by: ALK-Abelló A/S

Efficacy and Safety of the SQ Tree Sublingual Immunotherapy Tablet in Children and Adolescents With Moderate to Severe Allergic Rhinitis and/or Conjunctivitis Induced by Pollen From Birch and Trees Belonging to the Birch Homologous Group

This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score.

The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season.

The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase III, parallel-group, double-blind, placebo-controlled study to evaluate efficacy and safety of the tree SLIT-tablet in children and adolescents (5-17 years) who have rhinoconjunctivitis (with or without asthma) induced by pollen from birch trees or by trees belonging to the birch homologous group. Approximately 1000 children and adolescents will be enrolled in the trial and will receive either the tree SLIT-tablet or placebo.

The trial consists of 3 periods: a screening period, a treatment period, which includes pre-seasonal and co seasonal treatment, and a follow-up period. The duration is up to 13 months for each participant.

The trial is conducted in several European countries and in Canada.

Study Type

Interventional

Enrollment (Actual)

952

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Medical University of Vienna
      • Vienna, Austria, 1150
        • Allergy Center Vienna West
  • Belgium
    • Namur
      • Erpent, Namur, Belgium, 5101
        • Practice Dr Jean-Benoit Martinot
    • Oost-Vlandeeren
      • Gent, Oost-Vlandeeren, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven
  • Canada
      • Québec, Canada, G1V 4W2
        • Clinique Specialisee En Allergie De La Capitale
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus Universitetshospital, Astma, Allergi- og Lungeklinikken for Born
      • Copenhagen, Denmark, 1364
        • Astma, Allergi- og Lungeklinik
      • Hellerup, Denmark, 2900
        • Gentofte Hospital Allergy Clinic
  • Germany
      • Duisburg, Germany, 40225
        • HNO Praxis Dr. Uta Thieme
      • Hamburg, Germany, 22549
        • Hautarztpraxis Dr. med. Daniela Kasche
      • Heidelberg, Germany, 69120
        • HNO-Praxis am Neckar
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
        • Kinder- u. Jugendmedizin
      • Mannheim, Baden-Württemberg, Germany, 68161
        • Gemeinschaftspraxis für Kinder und Jugendmedizin
    • Bayern
      • Munich, Bayern, Germany, 80802
        • Klinikum rechts der Isar der TUM
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Universitätsklinikum Gießen und Marburg GmbH - Klinik für Hals-, Nasen- und Ohrenheilkunde Sektion Rhinologie und Allergologie
    • Niedersachsen
      • Osnabrück, Niedersachsen, Germany, 49074
        • KliFOs - Klinische Forschung Osnabrück
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40217
        • Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin
      • Essen, Nordrhein-Westfalen, Germany, 15355
        • ENT Research GmbH
      • Hürth, Nordrhein-Westfalen, Germany, 50354
        • Kinder- und Jugendärzte
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Universitätsklinikum Münster
      • Neuss, Nordrhein-Westfalen, Germany, 41469
        • Praxis Dr.J. Funck
    • Rheinland-Pfalz
      • Herxheim, Rheinland-Pfalz, Germany, 76863
        • Praxis Dr. med. Karsten Jünger
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitätsmedizin der JGU
      • Schweigen-Rechtenbach, Rheinland-Pfalz, Germany, 76889
        • Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub
    • Sachsen
      • Dresden, Sachsen, Germany, 01139
        • Praxis Dr. Yury Yarin
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1037
        • Svábhegy Plusz Kft
      • Budapest, Hungary, 1089
        • Heim Pál Gyermekkórház
      • Budapest, Hungary, 1195
        • Kispesti Egeszsegugyi Intezet
    • Csongrád
      • Szeged, Csongrád, Hungary, 6720
        • Aranyklinika Kft
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Hospital of University of Health Sciences Kauno Klinikos
      • Vilnius, Lithuania, 8109
        • Alerginiu susirgimu diagnostikos ir gydymo centras
      • Vilnius, Lithuania, LT-06256
        • "Center of Innovative Allergology" JSC
    • Kauno Apskritis
      • Kaunas, Kauno Apskritis, Lithuania, 49387
        • JSC Ausros Medicinos Centras
      • Kaunas, Kauno Apskritis, Lithuania, LT-44269
        • "CD8 Klinika" JSC
    • Tauragės Apskritis
      • Taurage, Tauragės Apskritis, Lithuania, LT-72250
        • "Medicum centrum" JSC
    • Vilniaus Apskritis
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-01118
        • "Seimos gydytojas" JSC
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-08406
        • "Inlita" JSC Santara CTC
      • Vilnius, Vilniaus Apskritis, Lithuania, LT-08465
        • Allergy clinic "Perspektyvos" JSC
  • Netherlands
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7500KA
        • Medisch Spectrum Twente
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CN
        • Erasmus MC - Sophia Childrens Hospital
  • Poland
      • Czestochowa, Poland, 42-200
        • Centrum Medyczne Pratia Częstochowa
      • Gryfice, Poland, 72-300
        • Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz
      • Kielce, Poland, 25-355
        • ETG Kielce
      • Kraków, Poland, 30-363
        • Centrum Medyczne Plejady
      • Lublin, Poland, 20-095
        • ALERGOTEST s.c. Specjalistyczne Centrum Medyczne
      • Sucha Beskidzka, Poland, 34-200
        • Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan
      • Wroclaw, Poland, 53-201
        • "All-Med" Specjalistyczna Opieka Medyczna
      • Wroclaw, Poland, 53-201
        • Michal Bogacki DOBROSTAN
      • Wroclaw, Poland, 53-301
        • Michal Bogacki DOBROSTAN
      • Wroclaw, Poland, 53-428
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych "PROXIMUM" Sp. z o.o.
      • Łódź, Poland, 90-141
        • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego
      • Łódź, Poland, 90-329
        • WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
      • Łódź, Poland, 90-553
        • Centrum Alergologii Prof. K. Buczyłko Spółka z o.o.
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Centrum medyczne Pratia Bydgoszcz
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-552
        • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
    • Malopolskie
      • Tarnów, Malopolskie, Poland, 33-100
        • ALERGO-MED Spolka z o.o.
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-411
        • Malopolskie Centrum Alergologii
      • Kraków, Małopolskie, Poland, 30-033
        • Centrum Medyczne All-Med
      • Kraków, Małopolskie, Poland, 31-411
        • Centrum Medyczne Promed
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-879
        • NZOZ E-Vita
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-382
        • Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna
    • Łódzkie
      • Skierniewice, Łódzkie, Poland, 96-100
        • ETG Skierniewice
    • Śląskie
      • Katowice, Śląskie, Poland, 40-338
        • Specjalist. Praktyka Lek. dr n.med. Joanna Orlicz-Widawska
    • Świętokrzyskie
      • Skarżysko-Kamienna, Świętokrzyskie, Poland, 26-110
        • NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Public Enterprise State Scient
      • Moskva, Russian Federation, 115446
        • FGBUN" Federal Research Center for Nutrition and Biotechnology "
    • Moscow
      • Moskva, Moscow, Russian Federation, 117198
        • NRPC Pediatric Hematology, Oncology, Immunology n.a. Dmitriya Rogacheva - Multispecialty
    • Moskva
      • Moscow, Moskva, Russian Federation, 105554
        • Llc "Olla-Med"
      • Moscow, Moskva, Russian Federation, 119333
        • FGBU "Scientific center of children health" of RAMS
  • Slovakia
      • Levice, Slovakia, 935-31
        • DANIMED, spol. s.r.o.
      • Martin, Slovakia, 03601
        • Univerzitna Nemocnica Martin
      • Nové Zámky, Slovakia, 940 01
        • MedKol, s.r.o.
      • Prešov, Slovakia, 080 01
        • EMED s.r.o.
      • Rimavska Sobota, Slovakia, 979 01
        • Zoll-Med s.r.o., Ambulancia klinickej imunologie a alergologie
      • Vráble, Slovakia, 952 01
        • SIMIDA s.r.o.
      • Šurany, Slovakia, 942 01
        • Ambulancia klinickej imunologie a alergologie
    • Nitriansky Kraj
      • Komárno, Nitriansky Kraj, Slovakia, 945 01
        • ALERGO H2B s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female of any race/ethnicity aged ≥4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be ≥5 to <18 years old at the randomisation visit
  • A documented , physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening
  • Positive skin prick test (SPT) to Betula verrucosa at screening
  • Positive specific IgE to Bet v at screening

  • Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS:

    1. Sleep disturbance
    2. Impairment of daily activities, leisure and/or sport
    3. Impairment of school or work
    4. Troublesome symptoms

Exclusion Criteria:

  • A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS
  • A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS
  • Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation
  • Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject's usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma
  • Ongoing treatment with any allergy immunotherapy product
  • Severe chronic oral inflammation
  • A diagnosis of eosinophilic oesophagitis
  • A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
  • Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Gelatine (fish source), mannitol and sodium hydroxide
Drug: Placebo SLIT-tablet
Placebo
Experimental: Intervention/treatment
Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet
Drug: Tree SLIT-tablet
Sublingual allergy immunotherapy tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Total Combined Score (TCS) During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)
The primary endpoint of the trial was the average allergic rhinitis and/or conjunctivitis TCS during the BPS. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the BPS (mean duration of approximately 3-4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Total Combined Score (TCS) During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks)
Average TCS measured in the TPS. TPS includes hazel, alder, birch and oak pollen seasons. The average TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the TPS (mean duration of approximately 11 weeks)
Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)
Average rhinoconjunctivitis DSS during the BPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the BPS (mean duration of approximately 3-4 weeks)
Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks).
Average rhinoconjunctivitis DSS during the TPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the TPS (mean duration of approximately 11 weeks).
Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)
Average rhinoconjunctivitis DMS during the BPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the BPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the BPS (mean duration of approximately 3-4 weeks)
Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks)
Average rhinoconjunctivitis DMS during the TPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). TPS includes hazel, alder, birch and oak pollen seasons. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the TPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the TPS (mean duration of approximately 11 weeks)
Average Total Combined Score (TCS) During the Alder Hazel Pollen Season (AHPS)
Time Frame: During the AHPS (mean duration of approximately 6-7 weeks)
Average TCS during the AHPS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the AHPS (mean duration of approximately 6-7 weeks)
Average Daily Symptoms Score (DSS) During the Alder Hazel Pollen Season (AHPS)
Time Frame: During the AHPS (mean duration of approximately 6-7 weeks)
Average rhinoconjunctivitis DSS during the AHPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the AHPS (mean duration of approximately 6-7 weeks)
Average Daily Medication Score (DMS) During the Alder Hazel Pollen Season (AHPS)
Time Frame: During the AHPS (mean duration of approximately 6-7 weeks)
Average rhinoconjunctivitis DMS during the AHPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the AHPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the AHPS (mean duration of approximately 6-7 weeks)
Average Total Combined Score (TCS) During the Oak Pollen Season (OPS)
Time Frame: During the OPS (mean duration of approximately 3 weeks)
Average TCS measured in the OPS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the OPS (mean duration of approximately 3 weeks)
Average Daily Symptoms Score (DSS) During the Oak Pollen Season (OPS)
Time Frame: During the OPS (mean duration of approximately 3 weeks)
Average rhinoconjunctivitis DSS during the OPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms (on a scale of 0 to 18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the OPS (mean duration of approximately 3 weeks)
Average Daily Medication Score (DMS) During the Oak Pollen Season (OPS)
Time Frame: During the OPS (mean duration of approximately 3 weeks)
Average rhinoconjunctivitis DMS during the OPS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the OPS. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the OPS (mean duration of approximately 3 weeks)
Number of Severe Days During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)

The disease burden for participants was analyzed in terms of proportion of severe days.

A severe day was a day with a daily symptom score (DSS) ≥6 and ≥2 moderate symptoms or 1 severe symptom. The DSS ranged from 0 to 18 and was the sum of the 6 allergic rhinoconjunctivitis symptom scores, each scored on a scale from 0 to 3 (0 = no symptoms, 1= mild symptoms, 2= moderate symptoms and 3 = severe symptoms).

The proportion of severe days was the number of severe days divided by the number of days in the season.
During the BPS (mean duration of approximately 3-4 weeks)
Number of Severe Days During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks)

The disease burden for participants was analyzed in terms of proportion of severe days.

A severe day was a day with a daily symptom score (DSS) ≥6 and ≥2 moderate symptoms or 1 severe symptom. The DSS ranged from 0 to 18 and was the sum of the 6 allergic rhinoconjunctivitis symptom scores, each scored on a scale from 0 to 3 (0 = no symptoms, 1= mild symptoms, 2= moderate symptoms and 3 = severe symptoms).

The proportion of severe days was the number of severe days divided by the number of days in the season.
During the TPS (mean duration of approximately 11 weeks)
Number of Well Days During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)

A well day was defined as a day with no use of allergic rhinitis and/or conjunctivitis (AR/C) rescue medication (daily medication score =0) and daily symptom score ≤2.

The proportion of well days was the number of well days divided by the number of days in the season.
During the BPS (mean duration of approximately 3-4 weeks)
Number of Well Days During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks)

A well day was defined as a day with no use of allergic rhinitis and/or conjunctivitis (AR/C) rescue medication (daily medication score =0) and daily symptom score ≤2.

The proportion of well days was the number of well days divided by the number of days in the season.
During the TPS (mean duration of approximately 11 weeks)
Number of Symptom-free Days During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)
A a symptom-free day was defined as a day with no symptoms and with no use of rescue medication (Total Combined Score = 0). The proportion of symptom-free days was the number of symptom-free divided by the number of days in the season.
During the BPS (mean duration of approximately 3-4 weeks)
Number of Symptom-free Days During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks)

A a symptom-free day was defined as a day with no symptoms and with no use of rescue medication (Total Combined Score = 0).

The proportion of symptom-free days was the number of symptom-free divided by the number of days in the season.
During the TPS (mean duration of approximately 11 weeks)
Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)
A symptom-free day was defined as a day with no symptoms and with no use of rescue medication, i.e. total combined score (TCS) =0. Thus, the endpoint was categorized as a binary variable with a subject being a responder if he/she had no symptoms and had not used rescue medication during the season
During the BPS (mean duration of approximately 3-4 weeks)
Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks)
A symptom-free day was defined as a day with no symptoms and with no use of rescue medication, i.e. total combined score (TCS) = 0. Thus, the endpoint was categorized as a binary variable with a subject being a responder if he/she had no symptoms and had not used rescue medication during the tree pollen season.
During the TPS (mean duration of approximately 11 weeks)
Average Total Combined Score (TCS) (EAACI Scoring) During Birch Pollen Season (BPS)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)
The TCS European Academy of Allergy and Clinical Immunology (EAACI) scoring was calculated using the medication score proposed by EAACI and was the sum of the DSS/6 and the daily EAACI medication score (DMSEAACI) (values 0,1,2), and thus ranged 0-5 with higher scores indicating more combined allergy symptoms and medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the BPS (mean duration of approximately 3-4 weeks)
Average Total Combined Score (TCS) (EAACI Scoring) During Tree Pollen Season (TPS)
Time Frame: During the TPS (mean duration of approximately 11 weeks).
The TCS European Academy of Allergy and Clinical Immunology (EAACI) scoring was calculated using the medication score proposed by EAACI and was the sum of the DSS/6 and the daily EAACI medication score (DMSEAACI) (values 0,1,2), and thus ranged 0-5 with higher scores indicating more combined allergy symptoms and medication use. The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the TPS (mean duration of approximately 11 weeks).
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Birch Pollen Season (BPS) (12-17 Years Only)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)

The RQLQ measured the rhinoconjunctivitis quality of life. The RQLQ (for participants 12-17 years only) comprised 28 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall RQLQ score was the mean of the 28 item scores.

The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the BPS (mean duration of approximately 3-4 weeks)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Tree Pollen Season (TPS) (12-17 Years Only)
Time Frame: During the TPS (mean duration of approximately 11 weeks)

The RQLQ measured the rhinoconjunctivitis quality of life. The RQLQ (for participants 12-17 years only) comprised 28 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall RQLQ score was the mean of the 28 item scores.

The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the TPS (mean duration of approximately 11 weeks)
Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score During the Birch Pollen Season (BPS) (5-11 Years Only)
Time Frame: During the BPS (mean duration of approximately 3-4 weeks)

The PRQLQ measured the paediatric rhinoconjunctivitis quality of life. The PRQLQ consisted of 23 items, each scored on a 7-point scale ranging 0-6, with higher scores indicating worse quality of life. The overall PRQLQ score was the mean of the 23 item scores.

The primary estimand for the endpoint was the trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
During the BPS (mean duration of approximately 3-4 weeks)
Treatment Satisfaction (TSQM-9)
Time Frame: After ending treatment (after approximately 52 weeks of treatment)
Treatment satisfaction was measured using the 9-item treatment satisfaction questionnaire for medication (TSQM-9 questionnaire). After ending treatment, participants completed the TSQM-9 questionnaire which consisted of 9 items covering 3 domains. Each item was scored on a 5 point (ranging 1-5) or 7 point (ranging 1-7) scale. For each domain, item scores were summed and normalised to a 0-100 scale, with higher scores indicating better satisfaction.
After ending treatment (after approximately 52 weeks of treatment)
Patient-rated Global Evaluation of Treatment Efficacy
Time Frame: End of treatment (after approximately 52 weeks of treatment)

The global evaluation measured patient treatment satisfaction. After ending treatment, participants were asked: 'Compared to your rhinitis and/or conjunctivitis symptoms in the previous birch/tree pollen season, how have you felt overall in this birch/tree pollen season?'. The endpoint was evaluated as a binary endpoint; answer options 'much better' and 'better' were categorised as improved (taking value 1), while answer options 'the same', 'worse', and 'much worse' were categorised as not improved (taking value 0).

The primary estimand for the endpoint was he trial product estimand. The trial product estimand assesses the anticipated effect of the tree SLIT-tablet if it is taken as instructed.
End of treatment (after approximately 52 weeks of treatment)
Change From Baseline in Birch Specific IgE
Time Frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Birch specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation
From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Birch Specific IgG4
Time Frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Birch specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation.
From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Birch Specific IgE-Blocking Factor (IgE-BF)
Time Frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
The IgE-blocking factor assesses the effect of serum components (including IgE-blocking antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Alder, Hazel and Oak Specific IgE
Time Frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change in alder, hazel and oak specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation.
From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Alder, Hazel and Oak Specific IgG4
Time Frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change in alder, hazel and oak specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation.
From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks of treatment, on average)
Change From Baseline in Alder and Hazel Specific IgE- Blocking Factor (IgE-BF)
Time Frame: From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks treatment, on average)
The IgE-blocking factor assesses the effect of serum components (including IgE-blocking antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
From baseline (screening) to visit 4 (pre-TPS) (after approximately 19 weeks of treatment, on average) and from baseline (screening) to visit 6 (end of treatment) (after approximately 44 weeks treatment, on average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

Parexel

Investigators

  • Principal Investigator: Monika Gappa, Prof. MD, Evangelisches Krankenhaus Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TT-06
  • 2020-004372-17 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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