Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1460 participants
INTERVENTIONAL
2019-10-12
2023-04-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active treatment
HDM SLIT-tablet plus allergy and asthma rescue medication
Sublingual allergy immunotherapy tablet
For daily administration (1 tablet per day)
Placebo
Placebo oral tablet plus allergy and asthma rescue medication
Placebo
For daily administration (1 tablet per day)
Interventions
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Sublingual allergy immunotherapy tablet
For daily administration (1 tablet per day)
Placebo
For daily administration (1 tablet per day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
* Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
* Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of 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 Criteria
* Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
* Asthma requiring treatment with high dose of inhaled corticosteroid
* A relevant history of systemic allergic reaction
5 Years
11 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Antje Schuster, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Pediatrics, Düsseldorf University Hospital
Locations
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Allergy & Asthma Specialists Medical Group and Research Center
Huntington Beach, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States
Miami Clinical Research
Miami, Florida, United States
Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
Pensacola, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, United States
Aeroallergy Research Labs of Savannah, Inc.
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Deaconess Clinic Allergy
Evansville, Indiana, United States
PMG Research of McFarland Clinic
Ames, Iowa, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Clinical Research of The Ozarks Inc
Warrensburg, Missouri, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Allergy & Asthma Associates of Monmouth City
Little Silver, New Jersey, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States
The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital
Chapel Hill, North Carolina, United States
UNC Children's Raleigh
Raleigh, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
The Corvallis Clinic
Corvallis, Oregon, United States
West Ashley office: Charleston Allergy & Asthma
Charleston, South Carolina, United States
ADAC Research, PA
Greenville, South Carolina, United States
Charleston Allergy & Asthma
Summerville, South Carolina, United States
Biogenics Research Institute
San Antonio, Texas, United States
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States
Multiprofile Hospital for active treatment, Department of Pediatrics
Gabrovo, , Bulgaria
Multiprofile Hospital for Active Treatment, Department of Pediatrics
Kyustendil, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics
Razgrad, , Bulgaria
Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology
Razgrad, , Bulgaria
Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse
Rousse, , Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics
Sofia, , Bulgaria
Sv. Vratch and Sv.Sv. Kuzma i Damian
Sofia, , Bulgaria
Alitea-Med-Medical-Center
Sofia, , Bulgaria
Diagnostic-Consultative center Ritam TR
Stara Zagora, , Bulgaria
Halton Pediatric Allergy
Burlington, , Canada
Triple A Lab
Hamilton, , Canada
Kingston General Hospital - Division of Allergy & Immunology
Kingston, , Canada
CHU Ste-Justine
Montreal, , Canada
The Montreal Children's Hospital
Montreal, , Canada
Niagara Clinical Research
Niagara Falls, , Canada
Gordon Sussman Clinical Research, Inc.
North York, , Canada
Clinique spécialisée en allergie de la capitale
Québec, , Canada
Hospital for Sick Children
Toronto, , Canada
Joel Liem Medicine Professional Corporation
Windsor, , Canada
Hôpital Morvan - Service de Pédiatrie
Brest, , France
CHU de Montpellier - Service Pneumologie et Addictologie
Montpellier, , France
Kinderarztpraxis Bramsche
Bramsche, , Germany
HNO praxis - Dr Yury Yarin
Dresden, , Germany
Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
Frankfurt, , Germany
GMAP/HNO am Neckar
Heidelberg, , Germany
CD8 klinika
Kaunas, , Lithuania
Siauliai Republican Hospital
Šiauliai, , Lithuania
JSC Seimos gydytojas
Vilnius, , Lithuania
Center of Allergy Diagnosis and Treatment
Vilnius, , Lithuania
Inlita JSC, Santara KTC
Vilnius, , Lithuania
Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz
Gryfice, , Poland
Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska
Katowice, , Poland
Centrum Medyczne ALL-MED
Krakow, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Poradnia Alergologiczna
Lodz, , Poland
Poradnia Alergologiczna
Lodz, , Poland
Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk
Lublin, , Poland
Centrum Alergologii Teresa Hofman Sp. z o.o.
Poznan, , Poland
Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.
Rzeszów, , Poland
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
Rzeszów, , Poland
IRMED Irena Wojciechowska
Warsaw, , Poland
All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel
Wroclaw, , Poland
City Children's Hospital
Kolpino, , Russia
Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University
Krasnoyarsk, , Russia
NRC Institute of Immunology
Moscow, , Russia
Moscow City Children's Hospital No 9
Moscow, , Russia
City Сhildren's Сlinical Polyclinic No5
Perm, , Russia
I.P. Pavlov Ryazan State Medical University
Ryazan, , Russia
Medical Technologies" Ltd.
Saint Petersburg, , Russia
City Children's Polyclinic No44
Saint Petersburg, , Russia
ArsVitae Severo-Zapad LLC
Saint Petersburg, , Russia
North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation
Saint Petersburg, , Russia
Сurator LLC
Saint Petersburg, , Russia
City Children's Polyclinic No45
Saint Petersburg, , Russia
Сity Children's Polyclinic No 35
Saint Petersburg, , Russia
Smolensk State Medical University
Smolensk, , Russia
Scientific Medical Center for General Therapy and Pharmacology
Stavropol, , Russia
Regional Children's Hospital
Tomsk, , Russia
Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie
Košice, , Slovakia
Ambulancia klinickej imunologie a alergologie
Levice, , Slovakia
ALFA EL, Imunoalergologická ambulancia
Poprad, , Slovakia
Ambulancia klinickej imunologie a alergologie
Šurany, , Slovakia
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, , Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital de Sagunto
Sagunto, , Spain
Hospital de Sagunto
Valencia, , Spain
Hospital la Plana
Villarreal, , Spain
Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases
Chernivtsi, , Ukraine
Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center
Dnipro, , Ukraine
Dnipro City Children's Municipal Clinical Hospital #2
Dnipro, , Ukraine
City Children's Clinic № 16" of Kharkiv City Council
Kharkiv, , Ukraine
City Children's Clinical Hospital # 19" of Kharkiv City Council
Kharkiv, , Ukraine
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, , Ukraine
O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear
Kyiv, , Ukraine
State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine
Kyiv, , Ukraine
Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine
Kyiv, , Ukraine
Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center
Lviv, , Ukraine
Children's Clinical Hospital of Poltava Regional Council
Poltava, , Ukraine
Regional Children Clinical Hospital, Infectious-Diagnostic Department
Sumy, , Ukraine
Regional Children's Clinical Hospital of Vinnytsia Regional Council
Vinnytsia, , Ukraine
City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department
Zaporizhzhya, , Ukraine
Countries
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References
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Schuster A, Caimmi D, Nolte H, Novakova S, Mikler J, Foss-Skiftesvik MH, Osterdal AS, Emeryk A, Gagnon R, Pfaar O. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024 Nov 26;48:101136. doi: 10.1016/j.lanepe.2024.101136. eCollection 2025 Jan.
Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MT-12
Identifier Type: -
Identifier Source: org_study_id
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