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

NCT ID: NCT04878354

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 952 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2023-07-31

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.

Conditions

Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Gelatine (fish source), mannitol and sodium hydroxide

Group Type: PLACEBO_COMPARATOR

Placebo SLIT-tablet

Intervention Type: DRUG

Placebo

Intervention/treatment

Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet

Group Type: EXPERIMENTAL

Tree SLIT-tablet

Intervention Type: DRUG

Sublingual allergy immunotherapy tablets

Interventions

Tree SLIT-tablet

Sublingual allergy immunotherapy tablets

Intervention Type: DRUG

Placebo SLIT-tablet

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Gappa, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Evangelisches Krankenhaus Düsseldorf

Locations

Allergy Center Vienna West

Vienna, , Austria

Medical University of Vienna

Vienna, , Austria

Practice Dr Jean-Benoit Martinot

Erpent, Namur, Belgium

Universitair Ziekenhuis Gent

Ghent, Oost-Vlandeeren, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

CHU Sainte-Justine

Montreal, Quebec, Canada

Clinique specialisee en allergie de la capitale

Québec, , Canada

Aarhus Universitetshospital, Astma, Allergi- og Lungeklinikken for Born

Aarhus, , Denmark

Astma, Allergi- og Lungeklinik

Copenhagen, , Denmark

Gentofte Hospital Allergy Clinic

Hellerup, , Denmark

Kinder- u. Jugendmedizin

Heidelberg, Baden-Wurttemberg, Germany

Gemeinschaftspraxis für Kinder und Jugendmedizin

Mannheim, Baden-Wurttemberg, Germany

Klinikum rechts der Isar der TUM

Munich, Bavaria, Germany

Universitätsklinikum Gießen und Marburg GmbH - Klinik für Hals-, Nasen- und Ohrenheilkunde Sektion Rhinologie und Allergologie

Marburg, Hesse, Germany

KliFOs - Klinische Forschung Osnabrück

Osnabrück, Lower Saxony, Germany

Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin

Düsseldorf, North Rhine-Westphalia, Germany

ENT Research GmbH

Essen, North Rhine-Westphalia, Germany

Kinder- und Jugendärzte

Hürth, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Praxis Dr.J. Funck

Neuss, North Rhine-Westphalia, Germany

Praxis Dr. med. Karsten Jünger

Herxheim, Rhineland-Palatinate, Germany

Universitätsmedizin der JGU

Mainz, Rhineland-Palatinate, Germany

Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub

Schweigen-Rechtenbach, Rhineland-Palatinate, Germany

Praxis Dr. Yury Yarin

Dresden, Saxony, Germany

HNO Praxis Dr. Uta Thieme

Duisburg, , Germany

Hautarztpraxis Dr. med. Daniela Kasche

Hamburg, , Germany

HNO-Praxis am Neckar

Heidelberg, , Germany

Aranyklinika Kft

Szeged, Csongrád megye, Hungary

Svábhegy Plusz Kft

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Heim Pál Gyermekkórház

Budapest, , Hungary

Kispesti Egeszsegugyi Intezet

Budapest, , Hungary

JSC Ausros Medicinos Centras

Kaunas, Kaunas County, Lithuania

"CD8 Klinika" JSC

Kaunas, Kaunas County, Lithuania

"Medicum centrum" JSC

Tauragė, Tauragė County, Lithuania

"Seimos gydytojas" JSC

Vilnius, Vilnius County, Lithuania

"Inlita" JSC Santara CTC

Vilnius, Vilnius County, Lithuania

Allergy clinic "Perspektyvos" JSC

Vilnius, Vilnius County, Lithuania

Hospital of University of Health Sciences Kauno Klinikos

Kaunas, , Lithuania

Alerginiu susirgimu diagnostikos ir gydymo centras

Vilnius, , Lithuania

"Center of Innovative Allergology" JSC

Vilnius, , Lithuania

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Erasmus MC - Sophia Childrens Hospital

Rotterdam, South Holland, Netherlands

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne ALL-MED

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne PROMED

Krakow, Lesser Poland Voivodeship, Poland

Malopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship, Poland

ALERGO-MED Spolka z o.o.

Tarnów, Lesser Poland Voivodeship, Poland

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lublin Voivodeship, Poland

NZOZ E-Vita

Bialystok, Podlaskie Voivodeship, Poland

Specjalist. Praktyka Lek. dr n.med. Joanna Orlicz-Widawska

Katowice, Silesian Voivodeship, Poland

Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna

Szczecin, West Pomeranian Voivodeship, Poland

Centrum Medyczne Pratia Czestochowa

Częstochowa, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz

Gryfice, , Poland

ETG Kielce

Kielce, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego

Lodz, , Poland

WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka

Lodz, , Poland

Centrum Alergologii Prof. K. Buczyłko Spółka z o.o.

Lodz, , Poland

Alergotest s.c. Specjalistyczne Centrum Medyczne

Lublin, , Poland

Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan

Sucha Beskidzka, , Poland

"All-Med" Specjalistyczna Opieka Medyczna

Wroclaw, , Poland

Michal Bogacki DOBROSTAN

Wroclaw, , Poland

Michal Bogacki DOBROSTAN

Wroclaw, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych "PROXIMUM" Sp. z o.o.

Wroclaw, , Poland

ETG Skierniewice

Skierniewice, Łódź Voivodeship, Poland

NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.

Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Poland

LLC "Olla-Med"

Moscow, Moscow, Russia

NRPC Pediatric Hematology, Oncology, Immunology n.a. Dmitriya Rogacheva - Multispecialty

Moscow, Moscow, Russia

FGBU "Scientific center of children health" of RAMS

Moscow, Moscow, Russia

Public Enterprise State Scient

Moscow, , Russia

FGBUN" Federal Research Center for Nutrition and Biotechnology "

Moskva, , Russia

ALERGO H2B s.r.o.

Komárno, Nitra Region, Slovakia

DANIMED, spol. s.r.o.

Levice, , Slovakia

Univerzitna Nemocnica Martin

Martin, , Slovakia

MedKol, s.r.o.

Nové Zámky, , Slovakia

EMED s.r.o.

Prešov, , Slovakia

Zoll-Med s.r.o., Ambulancia klinickej imunologie a alergologie

Rimavská Sobota, , Slovakia

Ambulancia klinickej imunologie a alergologie

Šurany, , Slovakia

SIMIDA s.r.o.

Vráble, , Slovakia

Countries

Austria; Belgium; Canada; Denmark; Germany; Hungary; Lithuania; Netherlands; Poland; Russia; Slovakia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-004372-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TT-06

Identifier Type: -

Identifier Source: org_study_id