Clinical trial NCT04145219: House Dust Mite Allergy Trial In Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis Due to Dermatophagoides Farinae
Allergic Rhinitis Due to Dermatophagoides Pteronyssinus
Allergic Rhinitis Due to House Dust Mite
Keywords: Allergic rhinitis
HDM
pediatric
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 1460
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Secondary outcomes:
measure: The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial
timeFrame: Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment)
measure: The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: SABA Free Days During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: Rhinitis Mild Days During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period
timeFrame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
measure: House Dust Mite Specific IgE
timeFrame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
measure: House Dust Mite Specific IgG4
timeFrame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
measure: Total IgE
timeFrame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
measure: House Dust Mite IgE-Blocking Factor
timeFrame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy & Asthma Specialists Medical Group and Research Center
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, A P.C.
state: California
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: GCP, Global Clinical Professionals
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Savannah
country: United States
facility: Aeroallergy Research Labs of Savannah, Inc.
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Evansville
country: United States
facility: Deaconess Clinic Allergy
state: Indiana
city: Ames
country: United States
facility: PMG Research of McFarland Clinic
state: Iowa
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Warrensburg
country: United States
facility: Clinical Research of The Ozarks Inc
state: Missouri
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Little Silver
country: United States
facility: Allergy & Asthma Associates of Monmouth City
state: New Jersey
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Chapel Hill
country: United States
facility: The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital
state: North Carolina
city: Raleigh
country: United States
facility: UNC Children's Raleigh
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic
state: Oregon
city: Charleston
country: United States
facility: West Ashley office: Charleston Allergy & Asthma
state: South Carolina
city: Greenville
country: United States
facility: ADAC Research, PA
state: South Carolina
city: Summerville
country: United States
facility: Charleston Allergy & Asthma
state: South Carolina
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center, S.C.
state: Wisconsin
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for active treatment, Department of Pediatrics
city: Kyustendil
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment, Department of Pediatrics
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
city: Razgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics
city: Razgrad
country: Bulgaria
facility: Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology
city: Ruse
country: Bulgaria
facility: Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics
city: Sofia
country: Bulgaria
facility: Sv. Vratch and Sv.Sv. Kuzma i Damian
city: Sofia
country: Bulgaria
facility: Alitea-Med-Medical-Center
city: Stara Zagora
country: Bulgaria
facility: Diagnostic-Consultative center Ritam TR
city: Burlington
country: Canada
facility: Halton Pediatric Allergy
city: Hamilton
country: Canada
facility: Triple A Lab
city: Kingston
country: Canada
facility: Kingston General Hospital - Division of Allergy & Immunology
city: Montréal
country: Canada
facility: CHU Ste-Justine
city: Montréal
country: Canada
facility: The Montreal Children's Hospital
city: Niagara Falls
country: Canada
facility: Niagara Clinical Research
city: North York
country: Canada
facility: Gordon Sussman Clinical Research, Inc.
city: Québec
country: Canada
facility: Clinique spécialisée en allergie de la capitale
city: Toronto
country: Canada
facility: Hospital for Sick Children
city: Windsor
country: Canada
facility: Joel Liem Medicine Professional Corporation
city: Brest
country: France
facility: Hôpital Morvan - Service de Pédiatrie
city: Montpellier
country: France
facility: CHU de Montpellier - Service Pneumologie et Addictologie
city: Bramsche
country: Germany
facility: Kinderarztpraxis Bramsche
city: Dresden
country: Germany
facility: HNO praxis - Dr Yury Yarin
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
city: Heidelberg
country: Germany
facility: GMAP/HNO am Neckar
city: Kaunas
country: Lithuania
facility: CD8 klinika
city: Vilnius
country: Lithuania
facility: JSC Seimos gydytojas
city: Vilnius
country: Lithuania
facility: Center of Allergy Diagnosis and Treatment
city: Vilnius
country: Lithuania
facility: Inlita JSC, Santara KTC
city: Šiauliai
country: Lithuania
facility: Siauliai Republican Hospital
city: Gryfice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska
city: Kraków
country: Poland
facility: Centrum Medyczne ALL-MED
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Lublin
country: Poland
facility: Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk
city: Poznań
country: Poland
facility: Centrum Alergologii Teresa Hofman Sp. z o.o.
city: Rzeszow
country: Poland
facility: Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.
city: Rzeszów
country: Poland
facility: Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
city: Warszawa
country: Poland
facility: IRMED Irena Wojciechowska
city: Wrocław
country: Poland
facility: All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel
city: Łódź
country: Poland
facility: Poradnia Alergologiczna
city: Łódź
country: Poland
facility: Poradnia Alergologiczna
city: Kolpino
country: Russian Federation
facility: City Children's Hospital
city: Krasnoyarsk
country: Russian Federation
facility: Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University
city: Moscow
country: Russian Federation
facility: NRC Institute of Immunology
city: Moscow
country: Russian Federation
facility: Moscow City Children's Hospital No 9
city: Perm
country: Russian Federation
facility: City Сhildren's Сlinical Polyclinic No5
city: Ryazan'
country: Russian Federation
facility: I.P. Pavlov Ryazan State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Medical Technologies" Ltd.
city: Saint Petersburg
country: Russian Federation
facility: City Children's Polyclinic No44
city: Saint Petersburg
country: Russian Federation
facility: ArsVitae Severo-Zapad LLC
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: Сurator LLC
city: Saint Petersburg
country: Russian Federation
facility: City Children's Polyclinic No45
city: Saint Petersburg
country: Russian Federation
facility: Сity Children's Polyclinic No 35
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Stavropol'
country: Russian Federation
facility: Scientific Medical Center for General Therapy and Pharmacology
city: Tomsk
country: Russian Federation
facility: Regional Children's Hospital
city: Košice
country: Slovakia
facility: Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie
city: Levice
country: Slovakia
facility: Ambulancia klinickej imunologie a alergologie
city: Poprad
country: Slovakia
facility: ALFA EL, Imunoalergologická ambulancia
city: Šurany
country: Slovakia
facility: Ambulancia klinickej imunologie a alergologie
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Esplugues De Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
city: Sagunto
country: Spain
facility: Hospital de Sagunto
city: Valencia
country: Spain
facility: Hospital de Sagunto
city: Villarreal
country: Spain
facility: Hospital la Plana
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases
city: Dnipro
country: Ukraine
facility: Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center
city: Dnipro
country: Ukraine
facility: Dnipro City Children's Municipal Clinical Hospital #2
city: Kharkiv
country: Ukraine
facility: City Children's Clinic № 16" of Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: City Children's Clinical Hospital # 19" of Kharkiv City Council
city: Kryvyi Rih
country: Ukraine
facility: 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
city: Kyiv
country: Ukraine
facility: O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear
city: Kyiv
country: Ukraine
facility: State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine
city: Lviv
country: Ukraine
facility: Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center
city: Poltava
country: Ukraine
facility: Children's Clinical Hospital of Poltava Regional Council
city: Sumy
country: Ukraine
facility: Regional Children Clinical Hospital, Infectious-Diagnostic Department
city: Vinnytsya
country: Ukraine
facility: Regional Children's Clinical Hospital of Vinnytsia Regional Council
city: Zaporizhzhya
country: Ukraine
facility: City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department
Study officials:
affiliation: Professor of Pediatrics, Düsseldorf University Hospital
name: Antje Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.