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

NCT04878354 | Completed Phase 3 Results

• 2 other identifiers: TT-062020-004372-17
• Study Type: interventional
• Target: 952
• Locations: 11 countries
• Sites: 80

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?.

Conditions

Allergy

Keywords

Allergic rhinoconjunctivitis; Children; Adolescents; Birch

Outcome Measures

Primary Outcomes (1)

• Average Total Combined Score (TCS) During the Birch Pollen Season (BPS)

  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 Outcomes (32)

• Average Total Combined Score (TCS) During the Tree Pollen Season (TPS)

  During the TPS (mean duration of approximately 11 weeks)

• Average Daily Symptoms Score (DSS) During the Birch Pollen Season (BPS)

  During the BPS (mean duration of approximately 3-4 weeks)

• Average Daily Symptoms Score (DSS) During the Tree Pollen Season (TPS)

  During the TPS (mean duration of approximately 11 weeks).

• Average Daily Medication Score (DMS) During the Birch Pollen Season (BPS)

  During the BPS (mean duration of approximately 3-4 weeks)

• Average Daily Medication Score (DMS) During the Tree Pollen Season (TPS)

  During the TPS (mean duration of approximately 11 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Gelatine (fish source), mannitol and sodium hydroxide

Drug: Placebo SLIT-tablet

Intervention/treatment

EXPERIMENTAL

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

Drug: Tree SLIT-tablet

Interventions

Tree SLIT-tablet DRUG

Sublingual allergy immunotherapy tablets

Intervention/treatment

Placebo SLIT-tablet DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Sleep disturbance
• Impairment of daily activities, leisure and/or sport
• Impairment of school or work
• Troublesome symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• Parexel: collaborator

Study Sites (80)

Allergy Center Vienna West

Vienna, 1150, Austria

Location

Medical University of Vienna

Vienna, A-1090, Austria

Location

Practice Dr Jean-Benoit Martinot

Erpent, Namur, 5101, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlandeeren, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Clinique specialisee en allergie de la capitale

Québec, G1V 4W2, Canada

Location

Aarhus Universitetshospital, Astma, Allergi- og Lungeklinikken for Born

Aarhus, 8200, Denmark

Location

Astma, Allergi- og Lungeklinik

Copenhagen, 1364, Denmark

Location

Gentofte Hospital Allergy Clinic

Hellerup, 2900, Denmark

Location

Kinder- u. Jugendmedizin

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Gemeinschaftspraxis für Kinder und Jugendmedizin

Mannheim, Baden-Wurttemberg, 68161, Germany

Location

Klinikum rechts der Isar der TUM

Munich, Bavaria, 80802, Germany

Location

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

Marburg, Hesse, 35043, Germany

Location

KliFOs - Klinische Forschung Osnabrück

Osnabrück, Lower Saxony, 49074, Germany

Location

Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin

Düsseldorf, North Rhine-Westphalia, 40217, Germany

Location

ENT Research GmbH

Essen, North Rhine-Westphalia, 15355, Germany

Location

Kinder- und Jugendärzte

Hürth, North Rhine-Westphalia, 50354, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Praxis Dr.J. Funck

Neuss, North Rhine-Westphalia, 41469, Germany

Location

Praxis Dr. med. Karsten Jünger

Herxheim, Rhineland-Palatinate, 76863, Germany

Location

Universitätsmedizin der JGU

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub

Schweigen-Rechtenbach, Rhineland-Palatinate, 76889, Germany

Location

Praxis Dr. Yury Yarin

Dresden, Saxony, 01139, Germany

Location

HNO Praxis Dr. Uta Thieme

Duisburg, 40225, Germany

Location

Hautarztpraxis Dr. med. Daniela Kasche

Hamburg, 22549, Germany

Location

HNO-Praxis am Neckar

Heidelberg, 69120, Germany

Location

Aranyklinika Kft

Szeged, Csongrád megye, 6720, Hungary

Location

Svábhegy Plusz Kft

Budapest, 1037, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Heim Pál Gyermekkórház

Budapest, 1089, Hungary

Location

Kispesti Egeszsegugyi Intezet

Budapest, 1195, Hungary

Location

JSC Ausros Medicinos Centras

Kaunas, Kaunas County, 49387, Lithuania

Location

"CD8 Klinika" JSC

Kaunas, Kaunas County, LT-44269, Lithuania

Location

"Medicum centrum" JSC

Tauragė, Tauragė County, LT-72250, Lithuania

Location

"Seimos gydytojas" JSC

Vilnius, Vilnius County, LT-01118, Lithuania

Location

"Inlita" JSC Santara CTC

Vilnius, Vilnius County, LT-08406, Lithuania

Location

Allergy clinic "Perspektyvos" JSC

Vilnius, Vilnius County, LT-08465, Lithuania

Location

Hospital of University of Health Sciences Kauno Klinikos

Kaunas, LT-50161, Lithuania

Location

Alerginiu susirgimu diagnostikos ir gydymo centras

Vilnius, 8109, Lithuania

Location

"Center of Innovative Allergology" JSC

Vilnius, LT-06256, Lithuania

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7500KA, Netherlands

Location

Erasmus MC - Sophia Childrens Hospital

Rotterdam, South Holland, 3015 CN, Netherlands

Location

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Centrum Medyczne ALL-MED

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Centrum Medyczne PROMED

Krakow, Lesser Poland Voivodeship, 31-411, Poland

Location

Malopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship, 31-411, Poland

Location

ALERGO-MED Spolka z o.o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lublin Voivodeship, 20-552, Poland

Location

NZOZ E-Vita

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

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

Katowice, Silesian Voivodeship, 40-338, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna

Szczecin, West Pomeranian Voivodeship, 70-382, Poland

Location

Centrum Medyczne Pratia Czestochowa

Częstochowa, 42-200, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz

Gryfice, 72-300, Poland

Location

ETG Kielce

Kielce, 25-355, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego

Lodz, 90-141, Poland

Location

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

Lodz, 90-329, Poland

Location

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

Lodz, 90-553, Poland

Location

Alergotest s.c. Specjalistyczne Centrum Medyczne

Lublin, 20-095, Poland

Location

Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan

Sucha Beskidzka, 34-200, Poland

Location

"All-Med" Specjalistyczna Opieka Medyczna

Wroclaw, 53-201, Poland

Location

Michal Bogacki DOBROSTAN

Wroclaw, 53-201, Poland

Location

Michal Bogacki DOBROSTAN

Wroclaw, 53-301, Poland

Location

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

Wroclaw, 53-428, Poland

Location

ETG Skierniewice

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

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

Skarżysko-Kamienna, Świętokrzyskie Voivodeship, 26-110, Poland

Location

LLC "Olla-Med"

Moscow, Moscow, 105554, Russia

Location

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

Moscow, Moscow, 117198, Russia

Location

FGBU "Scientific center of children health" of RAMS

Moscow, Moscow, 119333, Russia

Location

Public Enterprise State Scient

Moscow, 115478, Russia

Location

FGBUN" Federal Research Center for Nutrition and Biotechnology "

Moskva, 115446, Russia

Location

ALERGO H2B s.r.o.

Komárno, Nitra Region, 945 01, Slovakia

Location

DANIMED, spol. s.r.o.

Levice, 935-31, Slovakia

Location

Univerzitna Nemocnica Martin

Martin, 03601, Slovakia

Location

MedKol, s.r.o.

Nové Zámky, 940 01, Slovakia

Location

EMED s.r.o.

Prešov, 080 01, Slovakia

Location

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

Rimavská Sobota, 979 01, Slovakia

Location

Ambulancia klinickej imunologie a alergologie

Šurany, 942 01, Slovakia

Location

SIMIDA s.r.o.

Vráble, 952 01, Slovakia

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Senior Director, Clinical Data Science
• Organization: ALK-Abelló A/S

clinicaltrials@alk.net

+4545747576

Study Officials

• Monika Gappa, Prof. MD

  Evangelisches Krankenhaus Düsseldorf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: May 7, 2021
• Study Start: April 7, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Locations

AU (2); CA (2); RU (5); SL (8); DE (17); DK (3); BE (3); HU (5); LI (9); NL (2); PL (24)