Clincosm LogoSign in Get a demo

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

Sponsor
ALK-Abelló A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04878354
Collaborator
Parexel (Industry)
1,000
Enrollment
75
Locations
2
Arms
29.8
Anticipated Duration (Months)
13.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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?.

Condition or Disease Intervention/Treatment Phase
  • Drug: SQ tree SLIT-tablet
  • Drug: Placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 7, 2021
Anticipated Primary Completion Date :
Jul 17, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Gelatine (fish source), mannitol and sodium hydroxide

Drug: Placebo
Placebo
Experimental: Intervention/treatment

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

Drug: SQ tree SLIT-tablet
Sublingual allergy immunotherapy tablets

Outcome Measures

Primary Outcome Measures

  1. Average total combined score (rhinoconjunctivitis symptoms and medication use) during the birch pollen season [3 months]

    European Academy of Allergy and Clinical Immunology - values 0,1,2 (The higher score means more symptoms and more rescue medication used)

Secondary Outcome Measures

  1. Average total combined score (rhinoconjunctivitis symptoms and medication use) during the tree pollen season [6 months]

    European Academy of Allergy and Clinical Immunology - values 0,1,2 (The higher score means more symptoms and more rescue medication used)

  2. Average daily symptom score during the birch pollen season [3 months]

    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. Average daily symptom score during the tree pollen season [6 months]

    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)

  4. Average daily medication score during the birch pollen season [3 months]

    The type and dose of rescue medication will be scored. Scores between 0-20 (the higher value means the most rescue medication used)

  5. Average daily medication score during the tree pollen season [6 months]

    The type and dose of rescue medication will be scored. Scores between 0-20 (the higher value means the most rescue medication used)

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Allergy Center Vienna West Vienna Austria 1150
2 Medical University of Vienna Vienna Austria A-1090
3 Practice Dr Jean-Benoit Martinot Erpent Namur Belgium 5101
4 Universitair Ziekenhuis Gent Gent Oost-Vlandeeren Belgium 9000
5 UZ Leuven Leuven Vlaams Brabant Belgium 3000
6 CHU Sainte-Justine Montréal Quebec Canada H3T 1C5
7 Clinique specialisee en allergie de la capitale Québec Canada G1V 4W2
8 Astma, Allergi- og Lungeklinik Copenhagen Denmark 1364
9 Gentofte Hospital Allergy Clinic Hellerup Denmark 2900
10 Kinder- und Jugendärztliche Gemeinschaftspraxis Dr. med. Matthias J. Gelb Dr. med. Roland A. Knecht Bretten Baden-Württemberg Germany 75015
11 Kinder- u. Jugendmedizin Heidelberg Baden-Württemberg Germany 69126
12 Gemeinschaftspraxis für Kinder und Jugendmedizin Mannheim Baden-Württemberg Germany 68161
13 Klinikum rechts der Isar der TUM Munich Bayern Germany 80802
14 Praxis für HNO-Heilkunde, Allergologie, Umweltmedizin Dreieich Hessen Germany 63303
15 Universitätsklinikum Gießen und Marburg GmbH - Klinik für Hals-, Nasen- und Ohrenheilkunde Sektion Rhinologie und Allergologie Marburg Hessen Germany 35043
16 Evangelisches Krankenhaus Düsseldorf - Klinik für Kinder- und Jugendmedizin Düsseldorf Nordrhein-Westfalen Germany 40217
17 ENT Research GmbH Essen Nordrhein-Westfalen Germany 15355
18 Kinder- und Jugendärzte Hürth Nordrhein-Westfalen Germany 50354
19 Universitätsklinikum Münster Münster Nordrhein-Westfalen Germany 48149
20 Praxis Dr.J. Funck Neuss Nordrhein-Westfalen Germany 41469
21 Kinderärzte im Recker Park Würselen Nordrhein-Westfalen Germany 52146
22 Praxis Dr. med. Karsten Jünger Herxheim Rheinland-Pfalz Germany 76863
23 Universitätsmedizin der JGU Mainz Rheinland-Pfalz Germany 55131
24 Kinderarztpraxis Dr. med. Siegfried Simmet und Simon Traub Schweigen-Rechtenbach Rheinland-Pfalz Germany 76889
25 Praxis Dr. Yury Yarin Dresden Sachsen Germany 01139
26 HNO Praxis Dr. Uta Thieme Duisburg Germany 40225
27 Hautarztpraxis Dr. med. Daniela Kasche Hamburg Germany 22549
28 HNO-Praxis am Neckar Heidelberg Germany 69120
29 HNO Gemeinschaftspraxis Wiesbaden Germany 65183
30 Aranyklinika Kft Szeged Csongrád Hungary 6720
31 Svábhegy Plusz Kft Budapest Hungary 1037
32 Heim Pál Gyermekkórház Budapest Hungary 1089
33 Kispesti Egeszsegugyi Intezet Budapest Hungary 1195
34 Semmelweis Egyetem Budapest Hungary H-1083
35 "CD8 Klinika" JSC Kaunas Kauno Apskritis Lithuania LT-44269
36 "Medicum centrum" JSC Taurage Tauragės Apskritis Lithuania LT-72250
37 "Seimos gydytojas" JSC Vilnius Vilniaus Apskritis Lithuania LT-01118
38 "Inlita" JSC Santara CTC Vilnius Vilniaus Apskritis Lithuania LT-08406
39 Allergy clinic "Perspektyvos" JSC Vilnius Vilniaus Apskritis Lithuania LT-08465
40 Hospital of University of Health Sciences Kauno Klinikos Kaunas Lithuania LT-50161
41 "Center of Innovative Allergology" JSC Vilnius Lithuania LT-06256
42 Medisch Spectrum Twente Enschede Overijssel Netherlands 7500KA
43 Erasmus MC - Sophia Childrens Hospital Rotterdam Zuid-Holland Netherlands 3015 CN
44 Centrum Medyczne PRATIA Bydgoszcz Bydgoszcz Kujawsko-pomorskie Poland 85-796
45 Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna Lublin Lubelskie Poland 20-552
46 ALERGO-MED Spolka z o.o. Tarnów Malopolskie Poland 33-100
47 Malopolskie Centrum Alergologii Krakow Małopolskie Poland 31-411
48 Centrum Medyczne ALL-MED Kraków Małopolskie Poland 30-033
49 Centrum Medyczne PROMED Kraków Małopolskie Poland 31-411
50 Niepubliczny Zaklad Opieki Zdrowotnej "ALERGOLOGIA", Poradnia Alergologiczna Szczecin Zachodniopomorskie Poland 70-382
51 Centrum Medyczne Pratia Czestochowa Czestochowa Poland 42-200
52 Indywidualna Specjalistyczna Praktyka Lekarska lek. med. Elzbieta Matusz Gryfice Poland 72-300
53 ETG Kielce Kielce Poland 25-355
54 Centrum Medyczne Plejady Kraków Poland 30-363
55 Alergotest s.c. Specjalistyczne Centrum Medyczne Lublin Poland 20-095
56 Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan Sucha Beskidzka Poland 34-200
57 SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. N.Barlickiego Łódź Poland 90-141
58 WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka Łódź Poland 90-329
59 ETG Skierniewice Skierniewice Łódzkie Poland 96-100
60 Specjalist. Praktyka Lek. dr n.med. Joanna Orlicz-Widawska Katowice Śląskie Poland 40-338
61 NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J. Skarżysko-Kamienna Świętokrzyskie Poland 26-110
62 NRPC Pediatric Hematology, Oncology, Immunology n.a. Dmitriya Rogacheva - Multispecialty Moskva Moscow Russian Federation 117198
63 LLC "Olla-Med" Moscow Moskva Russian Federation 105554
64 FGBU "Scientific center of children health" of RAMS Moscow Moskva Russian Federation 119333
65 Public Enterprise State Scient Moscow Russian Federation 115478
66 FGBUN" Federal Research Center for Nutrition and Biotechnology " Moskva Russian Federation 115446
67 ALERGO H2B s.r.o. Komárno Nitriansky Kraj Slovakia 945 01
68 Imuline s.r.o. Bratislava Slovakia 841 04
69 Univerzitna Nemocnica Martin Martin Slovakia 03601
70 MedKol, s.r.o. Nové Zámky Slovakia 940 01
71 EMED s.r.o. Prešov Slovakia 080 01
72 Zoll-Med s.r.o., Ambulancia klinickej imunologie a alergologie Rimavska Sobota Slovakia 979 01
73 Ambulancia klin. imunologie Trnava Slovakia 917-01
74 SIMIDA s.r.o. Vráble Slovakia 952 01
75 Ambulancia klinickej imunologie a alergologie Šurany Slovakia 942 01

Sponsors and Collaborators

  • ALK-Abelló A/S
  • Parexel

Investigators

  • Principal Investigator: Monika Gappa, Prof. MD, Evangelisches Krankenhaus Düsseldorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT04878354
Other Study ID Numbers:
  • TT-06
  • 2020-004372-17
First Posted:
May 7, 2021
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ALK-Abelló A/S
Allergic rhinoconjunctivitis
Children
Adolescents
Birch

Study Results

No Results Posted as of Aug 15, 2022