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

Allergy Clinical Trial

— TreeTop  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878354
• Other study ID #: TT-06
• Secondary ID: 2020-004372-17
• Status: Completed
• Phase: Phase 3
• Start date: April 7, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• SQ tree SLIT-tablet
Sublingual allergy immunotherapy tablets
• Placebo
Placebo

Locations

Country	Name	City	State
Austria	Allergy Center Vienna West	Vienna
Austria	Medical University of Vienna	Vienna
Belgium	Practice Dr Jean-Benoit Martinot	Erpent	Namur
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlandeeren
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	Clinique specialisee en allergie de la capitale	Québec
Denmark	Aarhus Universitetshospital, Astma, Allergi- og Lungeklinikken for Born	Aarhus
Denmark	Astma, Allergi- og Lungeklinik	Copenhagen
Denmark	Gentofte Hospital Allergy Clinic	Hellerup
Germany	Praxis Dr. Yury Yarin	Dresden	Sachsen
Germany	HNO Praxis Dr. Uta Thieme	Duisburg
Germany	Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin	Düsseldorf	Nordrhein-Westfalen
Germany	ENT Research GmbH	Essen	Nordrhein-Westfalen
Germany	Hautarztpraxis Dr. med. Daniela Kasche	Hamburg
Germany	HNO-Praxis am Neckar	Heidelberg
Germany	Kinder- u. Jugendmedizin	Heidelberg	Baden-Württemberg
Germany	Praxis Dr. med. Karsten Jünger	Herxheim	Rheinland-Pfalz
Germany	Kinder- und Jugendärzte	Hürth	Nordrhein-Westfalen
Germany	Universitätsmedizin der JGU	Mainz	Rheinland-Pfalz
Germany	Gemeinschaftspraxis für Kinder und Jugendmedizin	Mannheim	Baden-Württemberg
Germany	Universitätsklinikum Gießen und Marburg GmbH - Klinik für Hals-, Nasen- und Ohrenheilkunde Sektion Rhinologie und Allergologie	Marburg	Hessen
Germany	Klinikum rechts der Isar der TUM	Munich	Bayern
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Germany	Praxis Dr.J. Funck	Neuss	Nordrhein-Westfalen
Germany	KliFOs - Klinische Forschung Osnabrück	Osnabrück	Niedersachsen
Germany	Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub	Schweigen-Rechtenbach	Rheinland-Pfalz
Hungary	Heim Pál Gyermekkórház	Budapest
Hungary	Kispesti Egeszsegugyi Intezet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Svábhegy Plusz Kft	Budapest
Hungary	Aranyklinika Kft	Szeged	Csongrád
Lithuania	"CD8 Klinika" JSC	Kaunas	Kauno Apskritis
Lithuania	Hospital of University of Health Sciences Kauno Klinikos	Kaunas
Lithuania	JSC Ausros Medicinos Centras	Kaunas	Kauno Apskritis
Lithuania	"Medicum centrum" JSC	Taurage	Taurages Apskritis
Lithuania	"Center of Innovative Allergology" JSC	Vilnius
Lithuania	"Inlita" JSC Santara CTC	Vilnius	Vilniaus Apskritis
Lithuania	"Seimos gydytojas" JSC	Vilnius	Vilniaus Apskritis
Lithuania	Alerginiu susirgimu diagnostikos ir gydymo centras	Vilnius
Lithuania	Allergy clinic "Perspektyvos" JSC	Vilnius	Vilniaus Apskritis
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	Erasmus MC - Sophia Childrens Hospital	Rotterdam	Zuid-Holland
Poland	NZOZ E-Vita	Bialystok	Podlaskie
Poland	Centrum Medyczne PRATIA Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Czestochowa	Czestochowa
Poland	Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz	Gryfice
Poland	Specjalist. Praktyka Lek. dr n.med. Joanna Orlicz-Widawska	Katowice	Slaskie
Poland	ETG Kielce	Kielce
Poland	Malopolskie Centrum Alergologii	Krakow	Malopolskie
Poland	Centrum Medyczne ALL-MED	Kraków	Malopolskie
Poland	Centrum Medyczne Plejady	Kraków
Poland	Centrum Medyczne PROMED	Kraków	Malopolskie
Poland	Centrum Alergologii Prof. K. Buczylko Spólka z o.o.	Lódz
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego	Lódz
Poland	WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka	Lódz
Poland	Alergotest s.c. Specjalistyczne Centrum Medyczne	Lublin
Poland	Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna	Lublin	Lubelskie
Poland	NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.	Skarzysko-Kamienna	Swietokrzyskie
Poland	ETG Skierniewice	Skierniewice	Lódzkie
Poland	Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan	Sucha Beskidzka
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna	Szczecin	Zachodniopomorskie
Poland	ALERGO-MED Spolka z o.o.	Tarnów	Malopolskie
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
Russian Federation	FGBU "Scientific center of children health" of RAMS	Moscow	Moskva
Russian Federation	LLC "Olla-Med"	Moscow	Moskva
Russian Federation	Public Enterprise State Scient	Moscow
Russian Federation	FGBUN" Federal Research Center for Nutrition and Biotechnology "	Moskva
Russian Federation	NRPC Pediatric Hematology, Oncology, Immunology n.a. Dmitriya Rogacheva - Multispecialty	Moskva	Moscow
Slovakia	Ambulancia klinickej imunologie a alergologie	Šurany
Slovakia	ALERGO H2B s.r.o.	Komárno	Nitriansky Kraj
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	Rimavska Sobota
Slovakia	SIMIDA s.r.o.	Vráble

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Parexel

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Denmark,  Germany,  Hungary,  Lithuania,  Netherlands,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average total combined score (rhinoconjunctivitis symptoms and medication use) during the birch pollen season	European Academy of Allergy and Clinical Immunology - values 0,1,2 (The higher score means more symptoms and more rescue medication used)	3 months
Secondary	Average total combined score (rhinoconjunctivitis symptoms and medication use) during the tree pollen season	European Academy of Allergy and Clinical Immunology - values 0,1,2 (The higher score means more symptoms and more rescue medication used)	6 months
Secondary	Average daily symptom score during the birch pollen season	Sum of the 6 allergic rhinoconjunctivitis symptom scores; No symptoms (0), Mild symptoms (1), Moderate symptoms (2), Severe symptoms (3). Total scores will be between 0-18 (higher scores means more symptoms)	3 months
Secondary	Average daily symptom score during the tree pollen season	Sum of the 6 allergic rhinoconjunctivitis symptom scores; No symptoms (0), Mild symptoms (1), Moderate symptoms (2), Severe symptoms (3). Total scores will be between 0-18 (higher scores means more symptoms)	6 months
Secondary	Average daily medication score during the birch pollen season	The type and dose of rescue medication will be scored. Scores between 0-20 (the higher value means the most rescue medication used)	3 months
Secondary	Average daily medication score during the tree pollen season	The type and dose of rescue medication will be scored. Scores between 0-20 (the higher value means the most rescue medication used)	6 months