House Dust Mite Allergy Trial In Children

Last updated: June 11, 2024
Sponsor: ALK-Abelló A/S
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

Placebo

Sublingual allergy immunotherapy tablet

Clinical Study ID

NCT04145219
MT-12
  • Ages 5-11
  • All Genders

Study Summary

A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects aged 5-11 years

  • A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with orwithout asthma) and with allergic rhinitis symptoms despite having received allergypharmacotherapy during the previous year prior to screening

  • Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14days of the baseline period

  • Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8of the last 14 days of the baseline period

  • Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D.farinae at screening

  • Lung function ≥ 70% of predicted value

Exclusion

Exclusion Criteria:

  • Sensitised and regularly exposed to perennial allergens

  • Any nasal or pharyngeal condition that could interfere with the safety or efficacyevaluation

  • Asthma requiring treatment with high dose of inhaled corticosteroid

  • A relevant history of systemic allergic reaction

Study Design

Total Participants: 1460
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 12, 2019
Estimated Completion Date:
April 21, 2023

Study Description

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.

In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

Connect with a study center

  • Multiprofile Hospital for active treatment, Department of Pediatrics

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment, Department of Pediatrics

    Kyustendil, 2500
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

    Plovdiv,
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse

    Ruse, 7002
    Bulgaria

    Site Not Available

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Alitea-Med-Medical-Center

    Sofia, 1618
    Bulgaria

    Site Not Available

  • Sv. Vratch and Sv.Sv. Kuzma i Damian

    Sofia, 1408
    Bulgaria

    Site Not Available

  • Diagnostic-Consultative center Ritam TR

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Halton Pediatric Allergy

    Burlington, L7L 6W6
    Canada

    Site Not Available

  • Triple A Lab

    Hamilton, L8S 1G5
    Canada

    Site Not Available

  • Kingston General Hospital - Division of Allergy & Immunology

    Kingston, K7L 2V7
    Canada

    Site Not Available

  • Cheema Research Inc

    Mississauga, L5A 3V4
    Canada

    Site Not Available

  • CHU Ste-Justine

    Montréal, H3T1C5
    Canada

    Site Not Available

  • The Montreal Children's Hospital

    Montréal, H4A 3J1
    Canada

    Site Not Available

  • Niagara Clinical Research

    Niagara Falls, L2G 1J4
    Canada

    Site Not Available

  • Gordon Sussman Clinical Research, Inc.

    North York,
    Canada

    Site Not Available

  • Ottawa Allergy Research Corp

    Ottawa, K1G 6C6
    Canada

    Site Not Available

  • Clinique spécialisée en allergie de la capitale

    Québec, G1V 4W2
    Canada

    Site Not Available

  • Hospital for Sick Children

    Toronto, M5G 1X8
    Canada

    Site Not Available

  • Joel Liem Medicine Professional Corporation

    Windsor, N8X 2G1
    Canada

    Site Not Available

  • Hôpital Morvan - Service de Pédiatrie

    Brest,
    France

    Site Not Available

  • CHU de Montpellier - Service Pneumologie et Addictologie

    Montpellier, 34090
    France

    Site Not Available

  • Kinderarztpraxis Bramsche

    Bramsche, 49565
    Germany

    Site Not Available

  • HNO praxis - Dr Yury Yarin

    Dresden, 01139
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf - Zentrum f. Kinder- u. Jugendmedizin

    Düsseldorf, 40235
    Germany

    Site Not Available

  • Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

    Frankfurt,
    Germany

    Site Not Available

  • GMAP/HNO am Neckar

    Heidelberg, 68120
    Germany

    Site Not Available

  • CD8 klinika

    Kaunas, LT-44191
    Lithuania

    Site Not Available

  • Center of Allergy Diagnosis and Treatment

    Vilnius, LT-08109
    Lithuania

    Site Not Available

  • Inlita JSC, Santara KTC

    Vilnius,
    Lithuania

    Site Not Available

  • JSC Seimos gydytojas

    Vilnius, LT-01118
    Lithuania

    Site Not Available

  • Vilnius Centro Outpatient Clinic

    Vilnius, LT-01117
    Lithuania

    Site Not Available

  • Siauliai Republican Hospital

    Šiauliai, LT-76231
    Lithuania

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz

    Gryfice, 72-300
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska

    Katowice, 40-338
    Poland

    Site Not Available

  • Centrum Medyczne ALL-MED

    Kraków, 30-033
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Kraków, 30-363
    Poland

    Site Not Available

  • Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk

    Lublin, 20-050
    Poland

    Site Not Available

  • Centrum Alergologii Teresa Hofman Sp. z o.o.

    Poznań, 60-214
    Poland

    Site Not Available

  • Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.

    Rzeszow, 35-612
    Poland

    Site Not Available

  • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

    Rzeszów,
    Poland

    Site Not Available

  • IRMED Irena Wojciechowska

    Warszawa, 01-157
    Poland

    Site Not Available

  • All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel

    Wrocław, 53-201
    Poland

    Site Not Available

  • Poradnia Alergologiczna

    Łódź, 90-329
    Poland

    Site Not Available

  • City Children's Hospital

    Kolpino, 196657
    Russian Federation

    Site Not Available

  • Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • Moscow City Children's Hospital No 9

    Moscow, 123317
    Russian Federation

    Site Not Available

  • NRC Institute of Immunology

    Moscow, 115478
    Russian Federation

    Site Not Available

  • City Сhildren's Сlinical Polyclinic No5

    Perm, 614066
    Russian Federation

    Site Not Available

  • Rostov-on-Don Clinical Diagnostic Center Zdorovie

    Rostov-on-Don, 344002
    Russian Federation

    Site Not Available

  • I.P. Pavlov Ryazan State Medical University

    Ryazan', 390026
    Russian Federation

    Site Not Available

  • ArsVitae Severo-Zapad LLC

    Saint Petersburg, 194223
    Russian Federation

    Site Not Available

  • City Children's Polyclinic No44

    Saint Petersburg, 191144
    Russian Federation

    Site Not Available

  • City Children's Polyclinic No45

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Medical Technologies" Ltd.

    Saint Petersburg, 191025
    Russian Federation

    Site Not Available

  • North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • Сity Children's Polyclinic No 35

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Сurator LLC

    Saint Petersburg, 196240
    Russian Federation

    Site Not Available

  • Samara State Medical University

    Samara, 443079
    Russian Federation

    Site Not Available

  • Smolensk State Medical University

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • Scientific Medical Center for General Therapy and Pharmacology

    Stavropol', 355000
    Russian Federation

    Site Not Available

  • Regional Children's Hospital

    Tomsk, 634009
    Russian Federation

    Site Not Available

  • Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie

    Košice,
    Slovakia

    Site Not Available

  • Ambulancia klinickej imunologie a alergologie

    Levice, 93501
    Slovakia

    Site Not Available

  • ALFA EL, Imunoalergologická ambulancia

    Poprad, 05801
    Slovakia

    Site Not Available

  • Ambulancia klinickej imunologie a alergologie

    Šurany, 94201
    Slovakia

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu

    Esplugues De Llobregat, 08950
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Jerez De La Frontera, 11407
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital de Sagunto

    Sagunto, 46520
    Spain

    Site Not Available

  • Hospital de Sagunto

    Valencia,
    Spain

    Site Not Available

  • Hospital la Plana

    Villarreal, 12540
    Spain

    Site Not Available

  • Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases

    Chernivtsi, 58023
    Ukraine

    Site Not Available

  • Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center

    Dnipro, 49006
    Ukraine

    Site Not Available

  • Dnipro City Children's Municipal Clinical Hospital #2

    Dnipro,
    Ukraine

    Site Not Available

  • City Children's Clinic № 16" of Kharkiv City Council

    Kharkiv, 61000
    Ukraine

    Site Not Available

  • City Children's Clinical Hospital # 19" of Kharkiv City Council

    Kharkiv, 61000
    Ukraine

    Site Not Available

  • Kryvyi Rih City Clinical Hospital #8'' of Kryvyi Rih City Council, Department of Pediatric Pulmonology; State Institution "Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

    Kryvyi Rih, 50082
    Ukraine

    Site Not Available

  • Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine

    Kyiv, 04050
    Ukraine

    Site Not Available

  • O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear

    Kyiv, 03057
    Ukraine

    Site Not Available

  • State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center

    Lviv, 79000
    Ukraine

    Site Not Available

  • Odesa Regional Children's Clinical Hospital" of Odesa Regional Council

    Odesa, 65031
    Ukraine

    Site Not Available

  • Children's Clinical Hospital of Poltava Regional Council

    Poltava, 36011
    Ukraine

    Site Not Available

  • Regional Children Clinical Hospital, Infectious-Diagnostic Department

    Sumy, 40031
    Ukraine

    Site Not Available

  • Regional Children's Clinical Hospital of Vinnytsia Regional Council

    Vinnytsya, 21029
    Ukraine

    Site Not Available

  • City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department

    Zaporizhzhya, 69076
    Ukraine

    Site Not Available

  • Clinical research center of Alabama

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Atria Clinical Research

    Little Rock, Arkansas 72209
    United States

    Site Not Available

  • Kern Research, Inc

    Bakersfield, California 93301
    United States

    Site Not Available

  • Allergy & Asthma Specialists Medical Group and Research Center

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90806
    United States

    Site Not Available

  • California Allergy and Asthma Medical Group

    Los Angeles, California 90025
    United States

    Site Not Available

  • Allergy & Asthma Medical Group and Research Center, A P.C.

    San Diego, California 92123
    United States

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center

    Pensacola, Florida 32503
    United States

    Site Not Available

  • GCP, Global Clinical Professionals

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Sarasota Clinical Research

    Sarasota, Florida 34239
    United States

    Site Not Available

  • University of South Florida Asthma, Allergy and Immunology

    Tampa, Florida 33613
    United States

    Site Not Available

  • Atlanta Allergy & Asthma Clinic, PA

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Omega Pediatrics and Weight Loss

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Aeroallergy Research Labs of Savannah, Inc.

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Deaconess Clinic Allergy

    Evansville, Indiana 47715
    United States

    Site Not Available

  • PMG Research of McFarland Clinic

    Ames, Iowa 50010
    United States

    Site Not Available

  • Bluegrass Allergy Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Institute for asthma and allergy

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Clinical Research of The Ozarks Inc

    Warrensburg, Missouri 64093
    United States

    Site Not Available

  • Summit Medical Group

    Berkeley Heights, New Jersey 07922
    United States

    Site Not Available

  • Allergy & Asthma Associates of Monmouth City

    Little Silver, New Jersey 07739
    United States

    Site Not Available

  • Atlantic Research Center, LLC

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • Rochester Regional Health

    Rochester, New York 14607
    United States

    Site Not Available

  • Allergy Partners of Western North Carolina

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • UNC Children's Raleigh

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • PMG Research of PHC

    Statesville, North Carolina 28677
    United States

    Site Not Available

  • Bernstein Clinical Research Center

    Cincinnati, Ohio 45231
    United States

    Site Not Available

  • Ohio Clinical Research Associates, Inc.

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

    Oklahoma City, Oklahoma 73131
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • The Corvallis Clinic

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • West Ashley office: Charleston Allergy & Asthma

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • ADAC Research, PA

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Charleston Allergy & Asthma

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • AARA Research Center

    Dallas, Texas 75321
    United States

    Site Not Available

  • Pediatric Associates, LLC

    Houston, Texas 77087
    United States

    Site Not Available

  • Biogenics Research Institute

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Allergy Asthma Research Institute

    Waco, Texas 76712
    United States

    Site Not Available

  • Allergy, Asthma & Sinus Center, S.C.

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

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