House Dust Mite Allergy Trial In Children

Allergic Rhinitis Due to House Dust Mite Clinical Trial

— MATIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145219
• Other study ID #: MT-12
• Status: Completed
• Phase: Phase 3
• Start date: October 12, 2019
• Est. completion date: April 21, 2023

Study information

• Verified date: June 2024
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1460
• Est. completion date: April 21, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Dermatophagoides Farinae
• Allergic Rhinitis Due to Dermatophagoides Pteronyssinus
• Allergic Rhinitis Due to House Dust Mite
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• Sublingual allergy immunotherapy tablet
For daily administration (1 tablet per day)

Other:
• Placebo
For daily administration (1 tablet per day)

Locations

Country	Name	City	State
Bulgaria	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	Ruse
Bulgaria	Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics	Sofia
Bulgaria	Alitea-Med-Medical-Center	Sofia
Bulgaria	Sv. Vratch and Sv.Sv. Kuzma i Damian	Sofia
Bulgaria	Diagnostic-Consultative center Ritam TR	Stara Zagora
Canada	Halton Pediatric Allergy	Burlington
Canada	Triple A Lab	Hamilton
Canada	Kingston General Hospital - Division of Allergy & Immunology	Kingston
Canada	CHU Ste-Justine	Montréal
Canada	The Montreal Children's Hospital	Montréal
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
France	Hôpital Morvan - Service de Pédiatrie	Brest
France	CHU de Montpellier - Service Pneumologie et Addictologie	Montpellier
Germany	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
Lithuania	Siauliai Republican Hospital	Šiauliai
Lithuania	CD8 klinika	Kaunas
Lithuania	Center of Allergy Diagnosis and Treatment	Vilnius
Lithuania	Inlita JSC, Santara KTC	Vilnius
Lithuania	JSC Seimos gydytojas	Vilnius
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz	Gryfice
Poland	Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska	Katowice
Poland	Centrum Medyczne ALL-MED	Kraków
Poland	Centrum Medyczne Plejady	Kraków
Poland	Poradnia Alergologiczna	Lódz
Poland	Poradnia Alergologiczna	Lódz
Poland	Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk	Lublin
Poland	Centrum Alergologii Teresa Hofman Sp. z o.o.	Poznan
Poland	Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.	Rzeszow
Poland	Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz	Rzeszów
Poland	IRMED Irena Wojciechowska	Warszawa
Poland	All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel	Wroclaw
Russian Federation	City Children's Hospital	Kolpino
Russian Federation	Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University	Krasnoyarsk
Russian Federation	Moscow City Children's Hospital No 9	Moscow
Russian Federation	NRC Institute of Immunology	Moscow
Russian Federation	City ?hildren's ?linical Polyclinic No5	Perm
Russian Federation	I.P. Pavlov Ryazan State Medical University	Ryazan'
Russian Federation	?ity Children's Polyclinic No 35	Saint Petersburg
Russian Federation	?urator LLC	Saint Petersburg
Russian Federation	ArsVitae Severo-Zapad LLC	Saint Petersburg
Russian Federation	City Children's Polyclinic No44	Saint Petersburg
Russian Federation	City Children's Polyclinic No45	Saint Petersburg
Russian Federation	Medical Technologies" Ltd.	Saint Petersburg
Russian Federation	North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation	Saint Petersburg
Russian Federation	Smolensk State Medical University	Smolensk
Russian Federation	Scientific Medical Center for General Therapy and Pharmacology	Stavropol'
Russian Federation	Regional Children's Hospital	Tomsk
Slovakia	Ambulancia klinickej imunologie a alergologie	Šurany
Slovakia	Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie	Košice
Slovakia	Ambulancia klinickej imunologie a alergologie	Levice
Slovakia	ALFA EL, Imunoalergologická ambulancia	Poprad
Spain	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
Ukraine	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	Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine	Kyiv
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	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	Vinnytsya
Ukraine	City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department	Zaporizhzhya
United States	PMG Research of McFarland Clinic	Ames	Iowa
United States	Allergy Partners of Western North Carolina	Asheville	North Carolina
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital	Chapel Hill	North Carolina
United States	West Ashley office: Charleston Allergy & Asthma	Charleston	South Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	University of Missouri	Columbia	Missouri
United States	The Corvallis Clinic	Corvallis	Oregon
United States	Deaconess Clinic Allergy	Evansville	Indiana
United States	Allergy, Asthma & Sinus Center, S.C.	Greenfield	Wisconsin
United States	ADAC Research, PA	Greenville	South Carolina
United States	Allergy & Asthma Specialists Medical Group and Research Center	Huntington Beach	California
United States	Allergy & Asthma Associates of Monmouth City	Little Silver	New Jersey
United States	California Allergy and Asthma Medical Group	Los Angeles	California
United States	Miami Clinical Research	Miami	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
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	Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center	Pensacola	Florida
United States	UNC Children's Raleigh	Raleigh	North Carolina
United States	GCP, Global Clinical Professionals	Saint Petersburg	Florida
United States	Biogenics Research Institute	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research Center, A P.C.	San Diego	California
United States	Sarasota Clinical Research	Sarasota	Florida
United States	Aeroallergy Research Labs of Savannah, Inc.	Savannah	Georgia
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Charleston Allergy & Asthma	Summerville	South Carolina
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Clinical Research of The Ozarks Inc	Warrensburg	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  France,  Germany,  Lithuania,  Poland,  Russian Federation,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	The average rhinitis DSS evaluates the treatment effect based on the reduction in daily rhinitis symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. 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 rhinitis DSS values, the 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	The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	Average rhinitis DMS evaluates the treatment effect based on the reduction in daily rhinitis medication use (on a scale of 0-12). Higher scores indicate more medication use. 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 rhinitis DMS values, the 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	The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period	Average rhinoconjunctivitis TCS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. 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 TCS values, the 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	The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	The average rhinoconjunctivitis DSS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptom score (on a scale of 0-18). Higher scores indicate more severe symptoms. 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 rhinoconjunctivitis DSS values, the 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	The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	Average rhinoconjunctivitis DMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0-20). Higher scores indicate more medication use. 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 rhinoconjunctivitis DMS values, the 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	Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial	The overall PRQLQ score measures the effect of rhinoconjunctivitis on participant's quality of life on a scale of 0-6. Higher scores indicate worse rhinoconjunctivitis-related quality of life.	Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment)
Secondary	The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	The average asthma DSS evaluates the treatment effect based on the reduction in daily asthma symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. 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 asthma DSS values, the 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	SABA Free Days During the Primary Efficacy Assessment Period	The endpoint SABA free days evaluates the treatment effect based on the reduction in SABA use. The higher the proportion of SABA free days the higher the estimated probability of a participant having a day where they didn't use SABA.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Secondary	Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period	Average weekly number of puffs of as-needed SABA use evaluates the treatment effect based on the reduction in the use of asthma reliever medication (SABA), and is calculated as 7 times the average of the daily number of puffs of as-needed SABA use. Higher values indicate more medication use.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Secondary	Rhinitis Mild Days During the Primary Efficacy Assessment Period	The endpoint rhinitis mild days evaluates the treatment effect based on days when participants have no symptoms or mild symptoms and no medication use. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis mild day.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Secondary	Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period	The endpoint rhinitis exacerbation days evaluates the treatment effect based on days when participants have severe symptoms. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis exacerbation day.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Secondary	Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	Average rhinitis CSMS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and/or medication use. For this endpoint, the rhinitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy & Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. 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 rhinitis CSMS values, the 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	Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	Average rhinoconjunctivitis CSMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and/or medication use. For this endpoint, the rhinoconjunctivitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy & Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. 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 rhinoconjunctivitis CSMS values, the 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	House Dust Mite Specific IgE	House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
Secondary	House Dust Mite Specific IgG4	House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
Secondary	Total IgE	The change in total IgE was measured from screening to the end of trial.	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
Secondary	House Dust Mite IgE-Blocking Factor	The IgE-blocking factor assesses the effect of serum components (including IgE-blocing antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)