Clinical trial NCT04878354: A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Allergic rhinoconjunctivitis
Children
Adolescents
Birch
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2021-05-07
Enrollment: 952
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Total Combined Score (TCS) During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
Secondary outcomes:
measure: Average Total Combined Score (TCS) During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks).
measure: Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Average Total Combined Score (TCS) During the Alder Hazel Pollen Season (AHPS)
timeFrame: During the AHPS (mean duration of approximately 6-7 weeks)
measure: Average Daily Symptoms Score (DSS) During the Alder Hazel Pollen Season (AHPS)
timeFrame: During the AHPS (mean duration of approximately 6-7 weeks)
measure: Average Daily Medication Score (DMS) During the Alder Hazel Pollen Season (AHPS)
timeFrame: During the AHPS (mean duration of approximately 6-7 weeks)
measure: Average Total Combined Score (TCS) During the Oak Pollen Season (OPS)
timeFrame: During the OPS (mean duration of approximately 3 weeks)
measure: Average Daily Symptoms Score (DSS) During the Oak Pollen Season (OPS)
timeFrame: During the OPS (mean duration of approximately 3 weeks)
measure: Average Daily Medication Score (DMS) During the Oak Pollen Season (OPS)
timeFrame: During the OPS (mean duration of approximately 3 weeks)
measure: Number of Severe Days During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Number of Severe Days During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Number of Well Days During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Number of Well Days During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Number of Symptom-free Days During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Number of Symptom-free Days During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Percentage of Patients Free of Symptoms and With no Use of Rescue Medication During the Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Average Total Combined Score (TCS) (EAACI Scoring) During Birch Pollen Season (BPS)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Average Total Combined Score (TCS) (EAACI Scoring) During Tree Pollen Season (TPS)
timeFrame: During the TPS (mean duration of approximately 11 weeks).
measure: Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Birch Pollen Season (BPS) (12-17 Years Only)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the Tree Pollen Season (TPS) (12-17 Years Only)
timeFrame: During the TPS (mean duration of approximately 11 weeks)
measure: Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score During the Birch Pollen Season (BPS) (5-11 Years Only)
timeFrame: During the BPS (mean duration of approximately 3-4 weeks)
measure: Treatment Satisfaction (TSQM-9)
timeFrame: After ending treatment (after approximately 52 weeks of treatment)
measure: Patient-rated Global Evaluation of Treatment Efficacy
timeFrame: End of treatment (after approximately 52 weeks of treatment)
measure: Change From Baseline in Birch Specific IgE
timeFrame: 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)
measure: Change From Baseline in Birch Specific IgG4
timeFrame: 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)
measure: Change From Baseline in Birch Specific IgE-Blocking Factor (IgE-BF)
timeFrame: 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)
measure: Change From Baseline in Alder, Hazel and Oak Specific IgE
timeFrame: 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)
measure: Change From Baseline in Alder, Hazel and Oak Specific IgG4
timeFrame: 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)
measure: Change From Baseline in Alder and Hazel Specific IgE- Blocking Factor (IgE-BF)
timeFrame: 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)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allergy Center Vienna West
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Erpent
country: Belgium
facility: Practice Dr Jean-Benoit Martinot
state: Namur
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlandeeren
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Québec
country: Canada
facility: Clinique specialisee en allergie de la capitale
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Astma, Allergi- og Lungeklinikken for Born
city: Copenhagen
country: Denmark
facility: Astma, Allergi- og Lungeklinik
city: Hellerup
country: Denmark
facility: Gentofte Hospital Allergy Clinic
city: Heidelberg
country: Germany
facility: Kinder- u. Jugendmedizin
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Gemeinschaftspraxis für Kinder und Jugendmedizin
state: Baden-Württemberg
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TUM
state: Bayern
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH - Klinik für Hals-, Nasen- und Ohrenheilkunde Sektion Rhinologie und Allergologie
state: Hessen
city: Osnabrück
country: Germany
facility: KliFOs - Klinische Forschung Osnabrück
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: ENT Research GmbH
state: Nordrhein-Westfalen
city: Hürth
country: Germany
facility: Kinder- und Jugendärzte
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: Praxis Dr.J. Funck
state: Nordrhein-Westfalen
city: Herxheim
country: Germany
facility: Praxis Dr. med. Karsten Jünger
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: Universitätsmedizin der JGU
state: Rheinland-Pfalz
city: Schweigen-Rechtenbach
country: Germany
facility: Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Praxis Dr. Yury Yarin
state: Sachsen
city: Duisburg
country: Germany
facility: HNO Praxis Dr. Uta Thieme
city: Hamburg
country: Germany
facility: Hautarztpraxis Dr. med. Daniela Kasche
city: Heidelberg
country: Germany
facility: HNO-Praxis am Neckar
city: Szeged
country: Hungary
facility: Aranyklinika Kft
state: Csongrád
city: Budapest
country: Hungary
facility: Svábhegy Plusz Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Heim Pál Gyermekkórház
city: Budapest
country: Hungary
facility: Kispesti Egeszsegugyi Intezet
city: Kaunas
country: Lithuania
facility: JSC Ausros Medicinos Centras
state: Kauno Apskritis
city: Kaunas
country: Lithuania
facility: "CD8 Klinika" JSC
state: Kauno Apskritis
city: Taurage
country: Lithuania
facility: "Medicum centrum" JSC
state: Tauragės Apskritis
city: Vilnius
country: Lithuania
facility: "Seimos gydytojas" JSC
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: "Inlita" JSC Santara CTC
state: Vilniaus Apskritis
city: Vilnius
country: Lithuania
facility: Allergy clinic "Perspektyvos" JSC
state: Vilniaus Apskritis
city: Kaunas
country: Lithuania
facility: Hospital of University of Health Sciences Kauno Klinikos
city: Vilnius
country: Lithuania
facility: Alerginiu susirgimu diagnostikos ir gydymo centras
city: Vilnius
country: Lithuania
facility: "Center of Innovative Allergology" JSC
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Sophia Childrens Hospital
state: Zuid-Holland
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne PRATIA Bydgoszcz
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
state: Lubelskie
city: Tarnów
country: Poland
facility: ALERGO-MED Spolka z o.o.
state: Malopolskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
state: Małopolskie
city: Kraków
country: Poland
facility: Centrum Medyczne ALL-MED
state: Małopolskie
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
state: Małopolskie
city: Bialystok
country: Poland
facility: NZOZ E-Vita
state: Podlaskie
city: Szczecin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna
state: Zachodniopomorskie
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Gryfice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz
city: Kielce
country: Poland
facility: ETG Kielce
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Lublin
country: Poland
facility: Alergotest s.c. Specjalistyczne Centrum Medyczne
city: Sucha Beskidzka
country: Poland
facility: Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan
city: Wroclaw
country: Poland
facility: "All-Med" Specjalistyczna Opieka Medyczna
city: Wroclaw
country: Poland
facility: Michal Bogacki DOBROSTAN
city: Wroclaw
country: Poland
facility: Michal Bogacki DOBROSTAN
city: Wroclaw
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych "PROXIMUM" Sp. z o.o.
city: Łódź
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego
city: Łódź
country: Poland
facility: WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
city: Łódź
country: Poland
facility: Centrum Alergologii Prof. K. Buczyłko Spółka z o.o.
city: Skierniewice
country: Poland
facility: ETG Skierniewice
state: Łódzkie
city: Katowice
country: Poland
facility: Specjalist. Praktyka Lek. dr n.med. Joanna Orlicz-Widawska
state: Śląskie
city: Skarżysko-Kamienna
country: Poland
facility: NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
state: Świętokrzyskie
city: Moskva
country: Russian Federation
facility: NRPC Pediatric Hematology, Oncology, Immunology n.a. Dmitriya Rogacheva - Multispecialty
state: Moscow
city: Moscow
country: Russian Federation
facility: LLC "Olla-Med"
state: Moskva
city: Moscow
country: Russian Federation
facility: FGBU "Scientific center of children health" of RAMS
state: Moskva
city: Moscow
country: Russian Federation
facility: Public Enterprise State Scient
city: Moskva
country: Russian Federation
facility: FGBUN" Federal Research Center for Nutrition and Biotechnology "
city: Komárno
country: Slovakia
facility: ALERGO H2B s.r.o.
state: Nitriansky Kraj
city: Levice
country: Slovakia
facility: DANIMED, spol. s.r.o.
city: Martin
country: Slovakia
facility: Univerzitna Nemocnica Martin
city: Nové Zámky
country: Slovakia
facility: MedKol, s.r.o.
city: Prešov
country: Slovakia
facility: EMED s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Zoll-Med s.r.o., Ambulancia klinickej imunologie a alergologie
city: Vráble
country: Slovakia
facility: SIMIDA s.r.o.
city: Šurany
country: Slovakia
facility: Ambulancia klinickej imunologie a alergologie
Study officials:
affiliation: Evangelisches Krankenhaus Düsseldorf
name: Monika Gappa, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: