House Dust Mite Allergy Trial In Children
MATIC
A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
1 other identifier
interventional
1,460
11 countries
113
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2019
Typical duration for phase_3
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedStudy Start
First participant enrolled
October 12, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2023
CompletedResults Posted
Study results publicly available
June 12, 2024
CompletedJune 12, 2024
June 1, 2024
3.5 years
October 11, 2019
March 22, 2024
June 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period
The primary endpoint in the trial was the average daily total combined rhinitis symptoms and medication score (TCRS) during the primary efficacy assessment period. The average daily TCRS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and medication score (on a scale of 0-24). Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCRS values, the primary endpoint is calculated as the average of those values.
8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Secondary Outcomes (17)
The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period
8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period
8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period
8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
- +12 more secondary outcomes
Study Arms (2)
Active treatment
EXPERIMENTALHDM SLIT-tablet plus allergy and asthma rescue medication
Placebo
PLACEBO COMPARATORPlacebo oral tablet plus allergy and asthma rescue medication
Interventions
For daily administration (1 tablet per day)
For daily administration (1 tablet per day)
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 5-11 years
- 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
You may not qualify if:
- Sensitised and regularly exposed to perennial allergens
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
Study Sites (113)
Allergy & Asthma Specialists Medical Group and Research Center
Huntington Beach, California, 92647, United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, 92123, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
Pensacola, Florida, 32503, United States
Sarasota Clinical Research
Sarasota, Florida, 34239, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, 33705, United States
Aeroallergy Research Labs of Savannah, Inc.
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Deaconess Clinic Allergy
Evansville, Indiana, 47715, United States
PMG Research of McFarland Clinic
Ames, Iowa, 50010, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
University of Missouri
Columbia, Missouri, 65201, United States
Clinical Research of The Ozarks Inc
Warrensburg, Missouri, 64093, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Allergy & Asthma Associates of Monmouth City
Little Silver, New Jersey, 07739, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801, United States
The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital
Chapel Hill, North Carolina, 27599, United States
UNC Children's Raleigh
Raleigh, North Carolina, 27607, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, 73131, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
The Corvallis Clinic
Corvallis, Oregon, 97330, United States
West Ashley office: Charleston Allergy & Asthma
Charleston, South Carolina, 29414, United States
ADAC Research, PA
Greenville, South Carolina, 29607, United States
Charleston Allergy & Asthma
Summerville, South Carolina, 29485, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228, United States
Multiprofile Hospital for active treatment, Department of Pediatrics
Gabrovo, 5300, Bulgaria
Multiprofile Hospital for Active Treatment, Department of Pediatrics
Kyustendil, 2500, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics
Razgrad, 7200, Bulgaria
Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology
Razgrad, 7200, Bulgaria
Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse
Rousse, 7002, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics
Sofia, 1407, Bulgaria
Sv. Vratch and Sv.Sv. Kuzma i Damian
Sofia, 1408, Bulgaria
Alitea-Med-Medical-Center
Sofia, 1618, Bulgaria
Diagnostic-Consultative center Ritam TR
Stara Zagora, 6000, Bulgaria
Halton Pediatric Allergy
Burlington, L7L 6W6, Canada
Triple A Lab
Hamilton, L8S 1G5, Canada
Kingston General Hospital - Division of Allergy & Immunology
Kingston, K7L 2V7, Canada
CHU Ste-Justine
Montreal, H3T1C5, Canada
The Montreal Children's Hospital
Montreal, H4A 3J1, Canada
Niagara Clinical Research
Niagara Falls, L2G 1J4, Canada
Gordon Sussman Clinical Research, Inc.
North York, Canada
Clinique spécialisée en allergie de la capitale
Québec, G1V 4W2, Canada
Hospital for Sick Children
Toronto, M5G 1X8, Canada
Joel Liem Medicine Professional Corporation
Windsor, N8X 2G1, Canada
Hôpital Morvan - Service de Pédiatrie
Brest, France
CHU de Montpellier - Service Pneumologie et Addictologie
Montpellier, 34090, France
Kinderarztpraxis Bramsche
Bramsche, 49565, Germany
HNO praxis - Dr Yury Yarin
Dresden, 01139, Germany
Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
Frankfurt, Germany
GMAP/HNO am Neckar
Heidelberg, 68120, Germany
CD8 klinika
Kaunas, LT-44191, Lithuania
Siauliai Republican Hospital
Šiauliai, LT-76231, Lithuania
JSC Seimos gydytojas
Vilnius, LT-01118, Lithuania
Center of Allergy Diagnosis and Treatment
Vilnius, LT-08109, Lithuania
Inlita JSC, Santara KTC
Vilnius, Lithuania
Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz
Gryfice, 72-300, Poland
Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska
Katowice, 40-338, Poland
Centrum Medyczne ALL-MED
Krakow, 30-033, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Poradnia Alergologiczna
Lodz, 90-141, Poland
Poradnia Alergologiczna
Lodz, 90-329, Poland
Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk
Lublin, 20-050, Poland
Centrum Alergologii Teresa Hofman Sp. z o.o.
Poznan, 60-214, Poland
Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.
Rzeszów, 35-612, Poland
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
Rzeszów, Poland
IRMED Irena Wojciechowska
Warsaw, 01-157, Poland
All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel
Wroclaw, 53-201, Poland
City Children's Hospital
Kolpino, 196657, Russia
Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University
Krasnoyarsk, 660022, Russia
NRC Institute of Immunology
Moscow, 115478, Russia
Moscow City Children's Hospital No 9
Moscow, 123317, Russia
City Сhildren's Сlinical Polyclinic No5
Perm, 614066, Russia
I.P. Pavlov Ryazan State Medical University
Ryazan, 390026, Russia
Medical Technologies" Ltd.
Saint Petersburg, 191025, Russia
City Children's Polyclinic No44
Saint Petersburg, 191144, Russia
ArsVitae Severo-Zapad LLC
Saint Petersburg, 194223, Russia
North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation
Saint Petersburg, 194291, Russia
Сurator LLC
Saint Petersburg, 196240, Russia
City Children's Polyclinic No45
Saint Petersburg, Russia
Сity Children's Polyclinic No 35
Saint Petersburg, Russia
Smolensk State Medical University
Smolensk, 214019, Russia
Scientific Medical Center for General Therapy and Pharmacology
Stavropol, 355000, Russia
Regional Children's Hospital
Tomsk, 634009, Russia
Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie
Košice, Slovakia
Ambulancia klinickej imunologie a alergologie
Levice, 93501, Slovakia
ALFA EL, Imunoalergologická ambulancia
Poprad, 05801, Slovakia
Ambulancia klinickej imunologie a alergologie
Šurany, 94201, Slovakia
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, 08950, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, 11407, Spain
Hospital de Sagunto
Sagunto, 46520, Spain
Hospital de Sagunto
Valencia, Spain
Hospital la Plana
Villarreal, 12540, Spain
Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases
Chernivtsi, 58023, Ukraine
Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center
Dnipro, 49006, Ukraine
Dnipro City Children's Municipal Clinical Hospital #2
Dnipro, Ukraine
City Children's Clinic № 16" of Kharkiv City Council
Kharkiv, 61000, Ukraine
City Children's Clinical Hospital # 19" of Kharkiv City Council
Kharkiv, 61000, 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, 50082, Ukraine
O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear
Kyiv, 03057, Ukraine
State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine
Kyiv, 03680, Ukraine
Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine
Kyiv, 04050, Ukraine
Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center
Lviv, 79000, Ukraine
Children's Clinical Hospital of Poltava Regional Council
Poltava, 36011, Ukraine
Regional Children Clinical Hospital, Infectious-Diagnostic Department
Sumy, 40031, Ukraine
Regional Children's Clinical Hospital of Vinnytsia Regional Council
Vinnytsia, 21029, Ukraine
City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department
Zaporizhzhya, 69076, Ukraine
Related Publications (2)
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.
PMID: 39678704DERIVEDField 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.
PMID: 32548677DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Operations Strategy
- Organization
- ALK-Abelló A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Antje Schuster, MD
Professor of Pediatrics, Düsseldorf University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 30, 2019
Study Start
October 12, 2019
Primary Completion
April 1, 2023
Study Completion
April 21, 2023
Last Updated
June 12, 2024
Results First Posted
June 12, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share