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

Study Purpose

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?.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04878354
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ALK-Abelló A/S
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Monika Gappa, Prof. MD
Principal Investigator Affiliation Evangelisches Krankenhaus Düsseldorf
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Austria, Belgium, Canada, Denmark, Germany, Hungary, Lithuania, Netherlands, Poland, Russian Federation, Slovakia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy
Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Gelatine (fish source), mannitol and sodium hydroxide

Experimental: Intervention/treatment

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

Interventions

Drug: - SQ tree SLIT-tablet

Sublingual allergy immunotherapy tablets

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Allergy Center Vienna West, Vienna, Austria

Status

Address

Allergy Center Vienna West

Vienna, , 1150

Medical University of Vienna, Vienna, Austria

Status

Address

Medical University of Vienna

Vienna, , A-1090

Practice Dr Jean-Benoit Martinot, Erpent, Namur, Belgium

Status

Address

Practice Dr Jean-Benoit Martinot

Erpent, Namur, 5101

Universitair Ziekenhuis Gent, Gent, Oost-Vlandeeren, Belgium

Status

Address

Universitair Ziekenhuis Gent

Gent, Oost-Vlandeeren, 9000

UZ Leuven, Leuven, Vlaams Brabant, Belgium

Status

Address

UZ Leuven

Leuven, Vlaams Brabant, 3000

CHU Sainte-Justine, Montréal, Quebec, Canada

Status

Address

CHU Sainte-Justine

Montréal, Quebec, H3T 1C5

Québec, Canada

Status

Address

Clinique specialisee en allergie de la capitale

Québec, , G1V 4W2

Aarhus, Denmark

Status

Address

Aarhus Universitetshospital, Astma, Allergi- og Lungeklinikken for Born

Aarhus, , 8200

Astma, Allergi- og Lungeklinik, Copenhagen, Denmark

Status

Address

Astma, Allergi- og Lungeklinik

Copenhagen, , 1364

Gentofte Hospital Allergy Clinic, Hellerup, Denmark

Status

Address

Gentofte Hospital Allergy Clinic

Hellerup, , 2900

Kinder- u. Jugendmedizin, Heidelberg, Baden-Württemberg, Germany

Status

Address

Kinder- u. Jugendmedizin

Heidelberg, Baden-Württemberg, 69126

Mannheim, Baden-Württemberg, Germany

Status

Address

Gemeinschaftspraxis für Kinder und Jugendmedizin

Mannheim, Baden-Württemberg, 68161

Klinikum rechts der Isar der TUM, Munich, Bayern, Germany

Status

Address

Klinikum rechts der Isar der TUM

Munich, Bayern, 80802

Marburg, Hessen, Germany

Status

Address

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

Marburg, Hessen, 35043

KliFOs - Klinische Forschung Osnabrück, Osnabrück, Niedersachsen, Germany

Status

Address

KliFOs - Klinische Forschung Osnabrück

Osnabrück, Niedersachsen, 49074

Düsseldorf, Nordrhein-Westfalen, Germany

Status

Address

Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin

Düsseldorf, Nordrhein-Westfalen, 40217

ENT Research GmbH, Essen, Nordrhein-Westfalen, Germany

Status

Address

ENT Research GmbH

Essen, Nordrhein-Westfalen, 15355

Kinder- und Jugendärzte, Hürth, Nordrhein-Westfalen, Germany

Status

Address

Kinder- und Jugendärzte

Hürth, Nordrhein-Westfalen, 50354

Universitätsklinikum Münster, Münster, Nordrhein-Westfalen, Germany

Status

Address

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, 48149

Praxis Dr.J. Funck, Neuss, Nordrhein-Westfalen, Germany

Status

Address

Praxis Dr.J. Funck

Neuss, Nordrhein-Westfalen, 41469

Praxis Dr. med. Karsten Jünger, Herxheim, Rheinland-Pfalz, Germany

Status

Address

Praxis Dr. med. Karsten Jünger

Herxheim, Rheinland-Pfalz, 76863

Universitätsmedizin der JGU, Mainz, Rheinland-Pfalz, Germany

Status

Address

Universitätsmedizin der JGU

Mainz, Rheinland-Pfalz, 55131

Schweigen-Rechtenbach, Rheinland-Pfalz, Germany

Status

Address

Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub

Schweigen-Rechtenbach, Rheinland-Pfalz, 76889

Praxis Dr. Yury Yarin, Dresden, Sachsen, Germany

Status

Address

Praxis Dr. Yury Yarin

Dresden, Sachsen, 01139

HNO Praxis Dr. Uta Thieme, Duisburg, Germany

Status

Address

HNO Praxis Dr. Uta Thieme

Duisburg, , 40225

Hautarztpraxis Dr. med. Daniela Kasche, Hamburg, Germany

Status

Address

Hautarztpraxis Dr. med. Daniela Kasche

Hamburg, , 22549

HNO-Praxis am Neckar, Heidelberg, Germany

Status

Address

HNO-Praxis am Neckar

Heidelberg, , 69120

Aranyklinika Kft, Szeged, Csongrád, Hungary

Status

Address

Aranyklinika Kft

Szeged, Csongrád, 6720

Svábhegy Plusz Kft, Budapest, Hungary

Status

Address

Svábhegy Plusz Kft

Budapest, , 1037

Semmelweis Egyetem, Budapest, Hungary

Status

Address

Semmelweis Egyetem

Budapest, , 1083

Heim Pál Gyermekkórház, Budapest, Hungary

Status

Address

Heim Pál Gyermekkórház

Budapest, , 1089

Kispesti Egeszsegugyi Intezet, Budapest, Hungary

Status

Address

Kispesti Egeszsegugyi Intezet

Budapest, , 1195

JSC Ausros Medicinos Centras, Kaunas, Kauno Apskritis, Lithuania

Status

Address

JSC Ausros Medicinos Centras

Kaunas, Kauno Apskritis, 49387

"CD8 Klinika" JSC, Kaunas, Kauno Apskritis, Lithuania

Status

Address

"CD8 Klinika" JSC

Kaunas, Kauno Apskritis, LT-44269

"Medicum centrum" JSC, Taurage, Tauragės Apskritis, Lithuania

Status

Address

"Medicum centrum" JSC

Taurage, Tauragės Apskritis, LT-72250

"Seimos gydytojas" JSC, Vilnius, Vilniaus Apskritis, Lithuania

Status

Address

"Seimos gydytojas" JSC

Vilnius, Vilniaus Apskritis, LT-01118

"Inlita" JSC Santara CTC, Vilnius, Vilniaus Apskritis, Lithuania

Status

Address

"Inlita" JSC Santara CTC

Vilnius, Vilniaus Apskritis, LT-08406

Allergy clinic "Perspektyvos" JSC, Vilnius, Vilniaus Apskritis, Lithuania

Status

Address

Allergy clinic "Perspektyvos" JSC

Vilnius, Vilniaus Apskritis, LT-08465

Kaunas, Lithuania

Status

Address

Hospital of University of Health Sciences Kauno Klinikos

Kaunas, , LT-50161

Vilnius, Lithuania

Status

Address

Alerginiu susirgimu diagnostikos ir gydymo centras

Vilnius, , 8109

"Center of Innovative Allergology" JSC, Vilnius, Lithuania

Status

Address

"Center of Innovative Allergology" JSC

Vilnius, , LT-06256

Medisch Spectrum Twente, Enschede, Overijssel, Netherlands

Status

Address

Medisch Spectrum Twente

Enschede, Overijssel, 7500KA

Erasmus MC - Sophia Childrens Hospital, Rotterdam, Zuid-Holland, Netherlands

Status

Address

Erasmus MC - Sophia Childrens Hospital

Rotterdam, Zuid-Holland, 3015 CN

Centrum Medyczne PRATIA Bydgoszcz, Bydgoszcz, Kujawsko-pomorskie, Poland

Status

Address

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz, Kujawsko-pomorskie, 85-796

Lublin, Lubelskie, Poland

Status

Address

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lubelskie, 20-552

ALERGO-MED Spolka z o.o., Tarnów, Malopolskie, Poland

Status

Address

ALERGO-MED Spolka z o.o.

Tarnów, Malopolskie, 33-100

Malopolskie Centrum Alergologii, Krakow, Małopolskie, Poland

Status

Address

Malopolskie Centrum Alergologii

Krakow, Małopolskie, 31-411

Centrum Medyczne ALL-MED, Kraków, Małopolskie, Poland

Status

Address

Centrum Medyczne ALL-MED

Kraków, Małopolskie, 30-033

Centrum Medyczne PROMED, Kraków, Małopolskie, Poland

Status

Address

Centrum Medyczne PROMED

Kraków, Małopolskie, 31-411

NZOZ E-Vita, Bialystok, Podlaskie, Poland

Status

Address

NZOZ E-Vita

Bialystok, Podlaskie, 15-879

Szczecin, Zachodniopomorskie, Poland

Status

Address

Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna

Szczecin, Zachodniopomorskie, 70-382

Centrum Medyczne Pratia Czestochowa, Czestochowa, Poland

Status

Address

Centrum Medyczne Pratia Czestochowa

Czestochowa, , 42-200

Gryfice, Poland

Status

Address

Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz

Gryfice, , 72-300

ETG Kielce, Kielce, Poland

Status

Address

ETG Kielce

Kielce, , 25-355

Centrum Medyczne Plejady, Kraków, Poland

Status

Address

Centrum Medyczne Plejady

Kraków, , 30-363

Lublin, Poland

Status

Address

Alergotest s.c. Specjalistyczne Centrum Medyczne

Lublin, , 20-095

Sucha Beskidzka, Poland

Status

Address

Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan

Sucha Beskidzka, , 34-200

Wroclaw, Poland

Status

Address

"All-Med" Specjalistyczna Opieka Medyczna

Wroclaw, , 53-201

Michal Bogacki DOBROSTAN, Wroclaw, Poland

Status

Address

Michal Bogacki DOBROSTAN

Wroclaw, , 53-201

Michal Bogacki DOBROSTAN, Wroclaw, Poland

Status

Address

Michal Bogacki DOBROSTAN

Wroclaw, , 53-301

Wroclaw, Poland

Status

Address

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

Wroclaw, , 53-428

Łódź, Poland

Status

Address

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego

Łódź, , 90-141

Łódź, Poland

Status

Address

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

Łódź, , 90-329

ETG Skierniewice, Skierniewice, Łódzkie, Poland

Status

Address

ETG Skierniewice

Skierniewice, Łódzkie, 96-100

Katowice, Śląskie, Poland

Status

Address

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

Katowice, Śląskie, 40-338

Skarżysko-Kamienna, Świętokrzyskie, Poland

Status

Address

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

Skarżysko-Kamienna, Świętokrzyskie, 26-110

Moskva, Moscow, Russian Federation

Status

Address

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

Moskva, Moscow, 117198

LLC "Olla-Med", Moscow, Moskva, Russian Federation

Status

Address

LLC "Olla-Med"

Moscow, Moskva, 105554

Moscow, Moskva, Russian Federation

Status

Address

FGBU "Scientific center of children health" of RAMS

Moscow, Moskva, 119333

Public Enterprise State Scient, Moscow, Russian Federation

Status

Address

Public Enterprise State Scient

Moscow, , 115478

Moskva, Russian Federation

Status

Address

FGBUN" Federal Research Center for Nutrition and Biotechnology "

Moskva, , 115446

ALERGO H2B s.r.o., Komárno, Nitriansky Kraj, Slovakia

Status

Address

ALERGO H2B s.r.o.

Komárno, Nitriansky Kraj, 945 01

DANIMED, spol. s.r.o., Levice, Slovakia

Status

Address

DANIMED, spol. s.r.o.

Levice, , 935-31

Univerzitna Nemocnica Martin, Martin, Slovakia

Status

Address

Univerzitna Nemocnica Martin

Martin, , 03601

MedKol, s.r.o., Nové Zámky, Slovakia

Status

Address

MedKol, s.r.o.

Nové Zámky, , 940 01

EMED s.r.o., Prešov, Slovakia

Status

Address

EMED s.r.o.

Prešov, , 080 01

Rimavska Sobota, Slovakia

Status

Address

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

Rimavska Sobota, , 979 01

SIMIDA s.r.o., Vráble, Slovakia

Status

Address

SIMIDA s.r.o.

Vráble, , 952 01

Šurany, Slovakia

Status

Address

Ambulancia klinickej imunologie a alergologie

Šurany, , 942 01

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