House Dust Mite Allergy Trial In Children (MATIC)

December 8, 2022 updated by: ALK-Abelló A/S

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Multiprofile Hospital for Active Treatment, Department of Pediatrics
      • Kyustendil, Bulgaria, 2500
        • Multiprofile Hospital for Active Treatment, Department of Pediatrics
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
      • Plovdiv, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
      • Razgrad, Bulgaria, 7200
        • Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics
      • Razgrad, Bulgaria, 7200
        • Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology
      • Ruse, Bulgaria, 7002
        • Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics
      • Sofia, Bulgaria, 1408
        • Sv. Vratch and Sv.Sv. Kuzma i Damian
      • Sofia, Bulgaria, 1618
        • Alitea-Med-Medical-Center
      • Stara Zagora, Bulgaria, 6000
        • Diagnostic-consultative center Ritam TR
  • Canada
      • Burlington, Canada, L7L 6W6
        • Halton Pediatric Allergy
      • Hamilton, Canada, L8S 1G5
        • Triple A Lab
      • Kingston, Canada, K7L 2V7
        • Kingston General Hospital - Division of Allergy & Immunology
      • Mississauga, Canada, L5A 3V4
        • Cheema Research Inc
      • Montréal, Canada, H3T1C5
        • CHU Ste-Justine
      • Montréal, Canada, H4A 3J1
        • The Montreal Children's Hospital
      • Niagara Falls, Canada, L2G 1J4
        • Niagara Clinical Research
      • North York, Canada
        • Gordon Sussman Clinical Research, Inc.
      • Québec, Canada, G1V 4W2
        • Clinique Specialisee en Allergie de la Capitale
      • Toronto, Canada, M5G 1X8
        • Hospital for Sick Children
      • Windsor, Canada, N8X 2G1
        • Joel Liem Medicine Professional Corporation
  • France
      • Brest, France
        • Hôpital Morvan - Service de Pédiatrie
      • Montpellier, France, 34090
        • CHU de Montpellier - Service Pneumologie et Addictologie
  • Germany
      • Bramsche, Germany, 49565
        • Kinderarztpraxis Bramsche
      • Dresden, Germany, 01139
        • HNO praxis - Dr Yury Yarin
      • Düsseldorf, Germany, 40235
        • Universitätsklinikum Düsseldorf - Zentrum f. Kinder- u. Jugendmedizin
      • Frankfurt, Germany
        • Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
      • Heidelberg, Germany, 68120
        • GMAP/HNO am Neckar
  • Lithuania
      • Kaunas, Lithuania, LT-44191
        • CD8 klinika
      • Vilnius, Lithuania, LT-01117
        • Vilnius Centro Outpatient Clinic
      • Vilnius, Lithuania, LT-01118
        • JSC Seimos gydytojas
      • Vilnius, Lithuania, LT-08109
        • Center of Allergy Diagnosis and Treatment
      • Vilnius, Lithuania
        • Inlita JSC, Santara KTC
      • Šiauliai, Lithuania, LT-76231
        • Siauliai Republican hospital
  • Poland
      • Gryfice, Poland, 72-300
        • Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz
      • Katowice, Poland, 40-338
        • Specjalistyczna Praktyka Lekarska dr n. med. Joanna Orlicz-Widawska
      • Kraków, Poland, 30-363
        • Centrum Medyczne PLEJADY
      • Kraków, Poland, 30-033
        • Centrum Medyczne All-Med
      • Lublin, Poland, 20-050
        • Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk
      • Poznań, Poland, 60-214
        • Centrum Alergologii Teresa Hofman Sp. Z o.o.
      • Rzeszow, Poland, 35-612
        • Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.
      • Rzeszów, Poland
        • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
      • Warszawa, Poland, 01-157
        • IRMED Irena Wojciechowska
      • Wrocław, Poland, 53-201
        • All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel
      • Łódź, Poland, 90-141
        • Poradnia Alergologiczna
      • Łódź, Poland, 90-329
        • Poradnia Alergologiczna
  • Russian Federation
      • Kolpino, Russian Federation, 196657
        • City Children's Hospital
      • Krasnoyarsk, Russian Federation, 660022
        • Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University
      • Moscow, Russian Federation, 115478
        • NRC Institute of Immunology
      • Moscow, Russian Federation, 123317
        • Moscow City Children's Hospital No 9
      • Perm, Russian Federation, 614066
        • City Сhildren's Сlinical Polyclinic No5
      • Ryazan', Russian Federation, 390026
        • I.P. Pavlov Ryazan State Medical University
      • Saint Petersburg, Russian Federation, 191025
        • Medical Technologies" Ltd.
      • Saint Petersburg, Russian Federation, 191144
        • City Children's Polyclinic No44
      • Saint Petersburg, Russian Federation, 194223
        • ArsVitae Severo-Zapad LLC
      • Saint Petersburg, Russian Federation, 194291
        • North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation
      • Saint Petersburg, Russian Federation, 196240
        • Сurator LLC
      • Saint Petersburg, Russian Federation
        • City Children's Polyclinic No45
      • Saint Petersburg, Russian Federation
        • Сity Children's Polyclinic No 35
      • Smolensk, Russian Federation, 214019
        • Smolensk State Medical University
      • Stavropol', Russian Federation, 355000
        • Scientific Medical Center for General Therapy and Pharmacology
      • Tomsk, Russian Federation, 634009
        • Regional Children's Hospital
  • Slovakia
      • Košice, Slovakia
        • Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie
      • Levice, Slovakia, 93501
        • Ambulancia klinickej imunologie a alergologie
      • Poprad, Slovakia, 05801
        • ALFA EL, Imunoalergologická ambulancia
      • Šurany, Slovakia, 94201
        • Ambulancia klinickej imunologie a alergologie
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Esplugues De Llobregat, Spain, 08950
        • Hospital Sant Joan de Deu
      • Jerez De La Frontera, Spain, 11407
        • Hospital Universitario de Jeréz De La Frontera
      • Sagunto, Spain, 46520
        • Hospital de Sagunto
      • Valencia, Spain
        • Hospital de Sagunto
      • Villarreal, Spain, 12540
        • Hospital la Plana
  • Ukraine
      • Chernivtsi, Ukraine, 58023
        • Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases
      • Dnipro, Ukraine, 49006
        • 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
      • Kharkiv, Ukraine, 61000
        • City Children's Clinic № 16" of Kharkiv City Council
      • Kharkiv, Ukraine, 61000
        • City Children's Clinical Hospital # 19" of Kharkiv City Council
      • Kryvyi Rih, Ukraine, 50082
        • 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
      • Kyiv, Ukraine, 03057
        • O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear
      • Kyiv, Ukraine, 03680
        • State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine
      • Kyiv, Ukraine, 04050
        • Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine
      • Lviv, Ukraine, 79000
        • Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center
      • Poltava, Ukraine, 36011
        • Children's Clinical Hospital of Poltava Regional Council
      • Sumy, Ukraine, 40031
        • Regional Children Clinical Hospital, Infectious-Diagnostic Department
      • Vinnytsya, Ukraine, 21029
        • Regional Children's Clinical Hospital of Vinnytsia Regional Council
      • Zaporizhzhya, Ukraine, 69076
        • City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research, Inc
      • Huntington Beach, California, United States, 92647
        • Allergy & Asthma Specialists Medical Group and Research Center
      • Los Angeles, California, United States, 90025
        • California Allergy and Asthma Medical Group
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group and Research Center, A P.C.
    • Florida
      • Miami, Florida, United States, 33155
        • Miami Clinical Research
      • Pensacola, Florida, United States, 32503
        • Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
      • Saint Petersburg, Florida, United States, 33705
        • GCP, Global Clinical Professionals
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Aeroallergy Research Labs of Savannah, Inc.
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Deaconess Clinic Allergy
    • Iowa
      • Ames, Iowa, United States, 50010
        • PMG Research of McFarland Clinic
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri
      • Warrensburg, Missouri, United States, 64093
        • Clinical Research of the Ozarks Inc
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group
      • Little Silver, New Jersey, United States, 07739
        • Allergy & Asthma Associates of Monmouth City
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Allergy Partners of Western North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital
      • Raleigh, North Carolina, United States, 27607
        • UNC Children's Raleigh
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
      • Oklahoma City, Oklahoma, United States, 73131
        • Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute, P.C.
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • West Ashley office: Charleston Allergy & Asthma
      • Greenville, South Carolina, United States, 29607
        • ADAC research, PA
      • Summerville, South Carolina, United States, 29485
        • Charleston Allergy & Asthma
    • Texas
      • San Antonio, Texas, United States, 78229
        • Biogenics Research Institute
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Allergy, Asthma & Sinus Center, S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects aged 5-11 years
  • A clinical history of HDM AR/C (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 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 to D. pteronyssinus or D. farinae at screening
  • Lung function ≥ 70% of predicted value

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
HDM SLIT-tablet plus allergy and asthma rescue medication
Biological: Sublingual allergy immunotherapy tablet
For daily administration (1 tablet per day)
Other Names:
  • Acarizax
  • Odactra
Placebo Comparator: Placebo
Placebo oral tablet plus allergy and asthma rescue medication
Other: Placebo
For daily administration (1 tablet per day)
Other Names:
  • Placebo sublingual tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined rhinitis symptoms and medication use
Time Frame: The last 8 weeks of approximately 12 months of treatment
The average daily sum of a rhinitis symptoms score and rhinitis medication score measured on a common scale
The last 8 weeks of approximately 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinitis symptoms
Time Frame: The last 8 weeks of approximately 12 months of treatment
The average of a daily rhinitis symptoms score
The last 8 weeks of approximately 12 months of treatment
Rhinitis medication
Time Frame: The last 8 weeks of approximately 12 months of treatment
The average of a daily rhinitis medication score
The last 8 weeks of approximately 12 months of treatment
Combined rhinoconjunctivitis symptoms and medication use
Time Frame: The last 8 weeks of approximately 12 months of treatment
The average daily sum of a rhinoconjunctivitis symptoms score and rhinoconjunctivitis medication score measured on a common scale
The last 8 weeks of approximately 12 months of treatment
Safety and tolerability
Time Frame: From first subject screened until last subject last visit
Adverse events and assessment of lung function
From first subject screened until last subject last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Investigators

  • Principal Investigator: Antje Schuster, MD, Professor of Pediatrics, Düsseldorf University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2019

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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