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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 Recruiting
Countries Austria, Canada, Denmark, Germany, Hungary, Lithuania, 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

Recruiting

Address

Allergy Center Vienna West

Vienna, , 1150

Site Contact

Fritz Horak, MD

f.horak@allergiezentrum.at

00431982412117

Medical University of Vienna, Vienna, Austria

Status

Not yet recruiting

Address

Medical University of Vienna

Vienna, , A-1090

Site Contact

Zsolt Szépfalusi, MD

Zsolt.Szepfalusi@meduniwien.ac.at

+43-1-40400-3188

CHU Sainte-Justine, Québec, Montréal, Canada

Status

Recruiting

Address

CHU Sainte-Justine

Québec, Montréal, H3T 1C5

Site Contact

Anne Des Roches, MD

a.des.roches@umontreal.ca

514-345-4931

Québec, Canada

Status

Recruiting

Address

Clinique specialisee en allergie de la capitale

Québec, , G1V 4W2

Site Contact

Remi Gagnon, MD

rgagnon@csacqc.ca

14186597741

Astma, Allergi- og Lungeklinik, Copenhagen, Denmark

Status

Recruiting

Address

Astma, Allergi- og Lungeklinik

Copenhagen, , 1364

Site Contact

Kim Nielsen, MD

kim.g.nielsen@regionh.dk

+4535451353

Gentofte Hospital Allergy Clinic, Hellerup, Denmark

Status

Recruiting

Address

Gentofte Hospital Allergy Clinic

Hellerup, , 2900

Site Contact

Kirsten Hansen, MD

kirsten.skamstrup.hansen@regionh.dk

+4538689982

Bretten, Baden-Württemberg, Germany

Status

Recruiting

Address

Kinder- und Jugendärztliche Gemeinschaftspraxis Dr. med. Matthias J. Gelb Dr. med. Roland A. Knecht

Bretten, Baden-Württemberg, 75015

Site Contact

Roland Knecht, MD

knecht@kinderarzt-bretten.de

+497252957413

Mannheim, Baden-Württemberg, Germany

Status

Recruiting

Address

Gemeinschaftspraxis für Kinder und Jugendmedizin

Mannheim, Baden-Württemberg, 68161

Site Contact

Falko Panzer, MD

panzer@paedresearch.de

+49 62149075050

Dreieich, Hessen, Germany

Status

Recruiting

Address

Praxis für HNO-Heilkunde, Allergologie, Umweltmedizin

Dreieich, Hessen, 63303

Site Contact

Elke Decot, MD

elkedecot@yahoo.de

+496103588750

Marburg, Hessen, Germany

Status

Recruiting

Address

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

Marburg, Hessen, 35043

Site Contact

Oliver Pfaar, MD

oliver@pfaar.org

+49 6421 58-65617

Düsseldorf, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin

Düsseldorf, Nordrhein-Westfalen, 40217

Site Contact

Monika Gappa, MD

Monika.Gappa@evk-duesseldorf.de

+49 211919481800

ENT Research GmbH, Essen, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

ENT Research GmbH

Essen, Nordrhein-Westfalen, 15355

Site Contact

Annette Fuhr-Horst, MD

info@hno-praxis-ruhr.de

+49 201 80 66 64 0

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

Status

Recruiting

Address

Kinder- und Jugendärzte

Hürth, Nordrhein-Westfalen, 50354

Site Contact

Ludwig Stapenhorst, MD

dr-stapenhorst@kinderaerzte-huerth.de

+49 2233/8086710

Universitätsklinikum Münster, Münster, Nordrhein-Westfalen, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Münster

Münster, Nordrhein-Westfalen, 48129

Site Contact

Randolf Brehler, MD

r.brehler@uni-muenster.de

+492518356506

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

Status

Recruiting

Address

Praxis Dr.J. Funck

Neuss, Nordrhein-Westfalen, 41469

Site Contact

Jürgen Funck, MD

drfneuss@arcor.de

+49 2137 2996

Kinderärzte im Recker Park, Würselen, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Kinderärzte im Recker Park

Würselen, Nordrhein-Westfalen, 52146

Site Contact

Franke Egbert, MD

kontakt@kinderaerzte-wuerselen.de

+49 2405 5600

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

Status

Recruiting

Address

Praxis Dr. med. Karsten Jünger

Herxheim, Rheinland-Pfalz, 76863

Site Contact

Karsten Jünger, MD

dr.karsten.juenger@gmx.de

+49 7276-6262

Schweigen-Rechtenbach, Rheinland-Pfalz, Germany

Status

Recruiting

Address

Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub

Schweigen-Rechtenbach, Rheinland-Pfalz, 76889

Site Contact

Siegfried Simmet, MD

simmet.praxis@gmail.com

+49 6342-62-38

Praxis Dr. Yury Yarin, Dresden, Sachsen, Germany

Status

Recruiting

Address

Praxis Dr. Yury Yarin

Dresden, Sachsen, 01139

Site Contact

Yuri Yarin, MD

dr.yarin@googlemail.com

+4935142780555

HNO Praxis Dr. Uta Thieme, Duisburg, Germany

Status

Recruiting

Address

HNO Praxis Dr. Uta Thieme

Duisburg, , 40225

Hautarztpraxis Dr. med. Daniela Kasche, Hamburg, Germany

Status

Not yet recruiting

Address

Hautarztpraxis Dr. med. Daniela Kasche

Hamburg, , 22549

Site Contact

Daniela Kasche, MD

daniela@dr-kasche.de

+49 40 866477700

HNO-Praxis am Neckar, Heidelberg, Germany

Status

Recruiting

Address

HNO-Praxis am Neckar

Heidelberg, , 69120

Site Contact

Andreas Horn, MD

horns04@t-online.de

+49 6221401010

Aranyklinika Kft, Szeged, Csongrád, Hungary

Status

Recruiting

Address

Aranyklinika Kft

Szeged, Csongrád, 6720

Site Contact

Zoltan Novak, MD

novak.zoltan@med.u-szeged.hu

3662317238

Svábhegy Plusz Kft, Budapest, Hungary

Status

Recruiting

Address

Svábhegy Plusz Kft

Budapest, , 1037

Site Contact

Csilla Csáki, MD

cscs@euroweb.hu

36 30 941 2943

Heim Pál Gyermekkórház, Budapest, Hungary

Status

Recruiting

Address

Heim Pál Gyermekkórház

Budapest, , 1089

Site Contact

Adrienne Nagy, MD

dr.nagy.adrienne@gmail.com

3614599100

Kispesti Egeszsegugyi Intezet, Budapest, Hungary

Status

Recruiting

Address

Kispesti Egeszsegugyi Intezet

Budapest, , 1195

Site Contact

Marta Fáczán, MD

faczan.marta@gmail.com

36 30 944 4370

Semmelweis Egyetem, Budapest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, , H-1083

Site Contact

Gyorgyi Mezei, MD

mezei.gyorgyi@med.semmelweis-univ.hu

3614591500

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

Status

Recruiting

Address

"CD8 Klinika" JSC

Kaunas, Kauno Apskritis, LT-44269

Site Contact

Jurate Staikuniene, MD

jstaikuniene@gmail.com

37037326063

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

Status

Recruiting

Address

"Medicum centrum" JSC

Taurage, Tauragės Apskritis, LT-72250

Site Contact

Iveta Skurvydiene, MD

skurvydiene.i@gmail.com

37069939903

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

Status

Recruiting

Address

"Seimos gydytojas" JSC

Vilnius, Vilniaus Apskritis, LT-01118

Site Contact

Odilija Rudzeviciene, MD

odilija.rudzeviciene@santa.lt

37052492416

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

Status

Recruiting

Address

"Inlita" JSC Santara CTC

Vilnius, Vilniaus Apskritis, LT-08406

Site Contact

Kestutis Cerniauskas, MD

kestas.cernis@gmail.com

37061237923

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

Status

Recruiting

Address

Allergy clinic "Perspektyvos" JSC

Vilnius, Vilniaus Apskritis, LT-08465

Site Contact

Ruta Dubakiene, MD

ruta.dubakiene@mf.vu.lt

37065433825

Kaunas, Lithuania

Status

Recruiting

Address

Hospital of University of Health Sciences Kauno Klinikos

Kaunas, , LT-50161

Site Contact

Brigita Sitkauskiene, MD

brigita.sitkauskiene@kaunoklinikos.lt

+37037326551

"Center of Innovative Allergology" JSC, Vilnius, Lithuania

Status

Recruiting

Address

"Center of Innovative Allergology" JSC

Vilnius, , LT-06256

Site Contact

Violeta Kvedariene, MD

kv.violeta@gmail.com

+370 655 22932

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

Status

Recruiting

Address

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz, Kujawsko-pomorskie, 85-796

Site Contact

Ewa Banach-Wawrzenczyk, MD

ebwawrzenczyk@pratia.pl

48 662 053 500

Lublin, Lubelskie, Poland

Status

Recruiting

Address

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lubelskie, 20-552

Site Contact

Izabella Krupa-Borek, MD

izabella.kb@wp.pl

48814628882

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

Status

Recruiting

Address

ALERGO-MED Spolka z o.o.

Tarnów, Malopolskie, 33-100

Site Contact

Olechowska Bernadetta Majorek, MD

bernadettaolechowska@gmail.com

48 14 627 26 25

Malopolskie Centrum Alergologii, Krakow, Małopolskie, Poland

Status

Recruiting

Address

Malopolskie Centrum Alergologii

Krakow, Małopolskie, 31-411

Site Contact

Małgorzata Bederska, MD

malgorzatabederska@gmail.com

48600876555

Centrum Medyczne ALL-MED, Kraków, Małopolskie, Poland

Status

Recruiting

Address

Centrum Medyczne ALL-MED

Kraków, Małopolskie, 30-033

Site Contact

Grazyna Pulka, MD

pulkaallmed@gmail.com

48 12 422 32 71

Centrum Medyczne PROMED, Kraków, Małopolskie, Poland

Status

Recruiting

Address

Centrum Medyczne PROMED

Kraków, Małopolskie, 31-411

Site Contact

Nina Mol, MD

Cscs@euroweb.hu

48 662 053 500

Szczecin, Zachodniopomorskie, Poland

Status

Recruiting

Address

Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna

Szczecin, Zachodniopomorskie, 70-382

Site Contact

Joanna Herbowska, MD

joanna@herbowska.com

48 91 488 00 12

Centrum Medyczne Pratia Czestochowa, Czestochowa, Poland

Status

Recruiting

Address

Centrum Medyczne Pratia Czestochowa

Czestochowa, , 42-200

Site Contact

Elzbieta Janusik, MD

ejanusik@pratia.pl

48 501 783 545

Gryfice, Poland

Status

Recruiting

Address

Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz

Gryfice, , 72-300

Site Contact

Elzbieta Matusz, MD

elzbieta_matusz@o2.pl

48 91 384 21 22

ETG Kielce, Kielce, Poland

Status

Recruiting

Address

ETG Kielce

Kielce, , 25-355

Site Contact

Anna Latos, MD

a.latos@etg-network.com

48 41-345-31-44

Centrum Medyczne Plejady, Kraków, Poland

Status

Recruiting

Address

Centrum Medyczne Plejady

Kraków, , 30-363

Site Contact

Ewa Cichocka-Jarosz, MD

mijarosz@cyfronet.pl

48 12 353 55 55

Sucha Beskidzka, Poland

Status

Recruiting

Address

Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan

Sucha Beskidzka, , 34-200

Site Contact

Zenon Bukowczan, MD

zbukowczan@poczta.onet.pl

48 33 874 01 61

Łódź, Poland

Status

Recruiting

Address

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego

Łódź, , 90-141

Site Contact

Piotr Kuna, MD

pkuna@barlicki.internetdsl.pl

48 42 67 76 834

ETG Skierniewice, Skierniewice, Łódzkie, Poland

Status

Recruiting

Address

ETG Skierniewice

Skierniewice, Łódzkie, 96-100

Site Contact

Bozena Kucinska, MD

b.kucinska@etg-network.com

48 46 833 47 56

Katowice, Śląskie, Poland

Status

Recruiting

Address

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

Katowice, Śląskie, 40-338

Site Contact

Joanna Orlicz - Widawska, MD

mycha3813@gmail.com

48 602 300 337

Skarżysko-Kamienna, Świętokrzyskie, Poland

Status

Recruiting

Address

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

Skarżysko-Kamienna, Świętokrzyskie, 26-110

Site Contact

Anna Bogusz, MD

bogusz.anna@yahoo.com

48 41 251 49 03

Moskva, Moscow, Russian Federation

Status

Recruiting

Address

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

Moskva, Moscow, 117198

Site Contact

Anna Shcherbina, MD

shcher26@hotmail.com

7(495)2876570

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

Status

Recruiting

Address

LLC "Olla-Med"

Moscow, Moskva, 105554

Site Contact

Vladislav Gaitukaev, MD

vgaitukaev@ollamed.ru

7 962 960 38 23

Moscow, Moskva, Russian Federation

Status

Recruiting

Address

FGBU "Scientific center of children health" of RAMS

Moscow, Moskva, 119333

Site Contact

Leila Namazova-Baranova, MD

leyla.s.namazova@gmail.com

74997832793

Public Enterprise State Scient, Moscow, Russian Federation

Status

Recruiting

Address

Public Enterprise State Scient

Moscow, , 115478

Site Contact

Natalia Ilina, MD

instimmun@yandex.ru

74996170800

Moskva, Russian Federation

Status

Recruiting

Address

FGBUN" Federal Research Center for Nutrition and Biotechnology "

Moskva, , 115446

Site Contact

Vera Revyakina, MD

5356797@mail.ru

74997943621

Imuline s.r.o., Bratislava, Slovakia

Status

Recruiting

Address

Imuline s.r.o.

Bratislava, , 841 04

Site Contact

Zuzana Abaffyova, MD

imuline@centrum.sk

+421 907 894 679

Univerzitna Nemocnica Martin, Martin, Slovakia

Status

Recruiting

Address

Univerzitna Nemocnica Martin

Martin, , 03601

Site Contact

Jan Mikler, MD

miklerjan@gmail.com

+421 905 236 765

MedKol, s.r.o., Nové Zámky, Slovakia

Status

Recruiting

Address

MedKol, s.r.o.

Nové Zámky, , 940 01

Site Contact

Monika Kolejakova, MD

medkolnz@gmail.com

+421 918 114 580

EMED s.r.o., Prešov, Slovakia

Status

Recruiting

Address

EMED s.r.o.

Prešov, , 080 01

Site Contact

Zuzana VOJTUŠOVÁ, MD

vojtusova@alergoimun.sk

+421 902 317 400

Rimavska Sobota, Slovakia

Status

Recruiting

Address

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

Rimavska Sobota, , 979 01

Site Contact

Lubica Zollerova, MD

zollerova@gmail.com

+421 475 424 382

Šurany, Slovakia

Status

Recruiting

Address

Ambulancia klinickej imunologie a alergologie

Šurany, , 942 01

Site Contact

Iveta Hajdenova, MD

ivetahajdenova@gmail.com

+421 356 501 612

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