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Allergic Rhinitis Due to Dermatophagoides FarinaePhase 3MATICNCT04145219

House Dust Mite Allergy Trial In Children

A Phase 3 study testing Sublingual allergy immunotherapy tablet in people with Allergic Rhinitis Due to Dermatophagoides Farinae and Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, run by ALK-Abelló A/S at 113 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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) Read more about this study

Who is it for?
Ages 5 to 11 years
What is being tested?
Sublingual allergy immunotherapy tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,460 participants
Where
113 sitesin 11 countries
Study dates
12 Oct 2019to 21 Apr 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

113 sites in 11 countries.

113 sites in 11 countries

United States29 sites

  • PMG Research of McFarland Clinic

    Ames, Iowa, 50010

  • Allergy Partners of Western North Carolina

    Asheville, North Carolina, 28801

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital

    Chapel Hill, North Carolina, 27599

  • West Ashley office: Charleston Allergy & Asthma

    Charleston, South Carolina, 29414

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45231

  • University of Missouri

    Columbia, Missouri, 65201

  • The Corvallis Clinic

    Corvallis, Oregon, 97330

  • Deaconess Clinic Allergy

    Evansville, Indiana, 47715

  • Allergy, Asthma & Sinus Center, S.C.

    Greenfield, Wisconsin, 53228

  • ADAC Research, PA

    Greenville, South Carolina, 29607

  • Allergy & Asthma Specialists Medical Group and Research Center

    Huntington Beach, California, 92647

  • Allergy & Asthma Associates of Monmouth City

    Little Silver, New Jersey, 07739

  • California Allergy and Asthma Medical Group

    Los Angeles, California, 90025

  • Miami Clinical Research

    Miami, Florida, 33155

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

    Oklahoma City, Oklahoma, 73131

  • Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center

    Pensacola, Florida, 32503

  • UNC Children's Raleigh

    Raleigh, North Carolina, 27607

  • Biogenics Research Institute

    San Antonio, Texas, 78229

  • Allergy & Asthma Medical Group and Research Center, A P.C.

    San Diego, California, 92123

  • Sarasota Clinical Research

    Sarasota, Florida, 34239

  • Aeroallergy Research Labs of Savannah, Inc.

    Savannah, Georgia, 31406

  • GCP, Global Clinical Professionals

    St. Petersburg, Florida, 33705

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Charleston Allergy & Asthma

    Summerville, South Carolina, 29485

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

  • Clinical Research of The Ozarks Inc

    Warrensburg, Missouri, 64093

Other trials in United States

Russia16 sites

  • City Children's Hospital

    Kolpino, 196657

  • Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University

    Krasnoyarsk, 660022

  • NRC Institute of Immunology

    Moscow, 115478

  • Moscow City Children's Hospital No 9

    Moscow, 123317

  • City Сhildren's Сlinical Polyclinic No5

    Perm, 614066

  • I.P. Pavlov Ryazan State Medical University

    Ryazan, 390026

  • Medical Technologies" Ltd.

    Saint Petersburg, 191025

  • City Children's Polyclinic No44

    Saint Petersburg, 191144

  • ArsVitae Severo-Zapad LLC

    Saint Petersburg, 194223

  • North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation

    Saint Petersburg, 194291

  • Сurator LLC

    Saint Petersburg, 196240

  • City Children's Polyclinic No45

    Saint Petersburg

  • Сity Children's Polyclinic No 35

    Saint Petersburg

  • Smolensk State Medical University

    Smolensk, 214019

  • Scientific Medical Center for General Therapy and Pharmacology

    Stavropol, 355000

  • Regional Children's Hospital

    Tomsk, 634009

Other trials in Russia

Ukraine14 sites

  • Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases

    Chernivtsi, 58023

  • Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center

    Dnipro, 49006

  • Dnipro City Children's Municipal Clinical Hospital #2

    Dnipro

  • City Children's Clinic № 16" of Kharkiv City Council

    Kharkiv, 61000

  • City Children's Clinical Hospital # 19" of Kharkiv City Council

    Kharkiv, 61000

  • 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

  • O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear

    Kyiv, 03057

  • State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine

    Kyiv, 03680

  • Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine

    Kyiv, 04050

  • Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center

    Lviv, 79000

  • Children's Clinical Hospital of Poltava Regional Council

    Poltava, 36011

  • Regional Children Clinical Hospital, Infectious-Diagnostic Department

    Sumy, 40031

  • Regional Children's Clinical Hospital of Vinnytsia Regional Council

    Vinnytsia, 21029

  • City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department

    Zaporizhzhya, 69076

Other trials in Ukraine

Poland12 sites

  • Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz

    Gryfice, 72-300

  • Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska

    Katowice, 40-338

  • Centrum Medyczne ALL-MED

    Krakow, 30-033

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Poradnia Alergologiczna

    Lodz, 90-141

  • Poradnia Alergologiczna

    Lodz, 90-329

  • Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk

    Lublin, 20-050

  • Centrum Alergologii Teresa Hofman Sp. z o.o.

    Poznan, 60-214

  • Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.

    Rzeszów, 35-612

  • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

    Rzeszów

  • IRMED Irena Wojciechowska

    Warsaw, 01-157

  • All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel

    Wroclaw, 53-201

Other trials in Poland

Bulgaria11 sites

  • Multiprofile Hospital for active treatment, Department of Pediatrics

    Gabrovo, 5300

  • Multiprofile Hospital for Active Treatment, Department of Pediatrics

    Kyustendil, 2500

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

    Plovdiv

  • Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics

    Razgrad, 7200

  • Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology

    Razgrad, 7200

  • Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse

    Rousse, 7002

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics

    Sofia, 1407

  • Sv. Vratch and Sv.Sv. Kuzma i Damian

    Sofia, 1408

  • Alitea-Med-Medical-Center

    Sofia, 1618

  • Diagnostic-Consultative center Ritam TR

    Stara Zagora, 6000

Other trials in Bulgaria

Canada10 sites

  • Halton Pediatric Allergy

    Burlington, L7L 6W6

  • Triple A Lab

    Hamilton, L8S 1G5

  • Kingston General Hospital - Division of Allergy & Immunology

    Kingston, K7L 2V7

  • CHU Ste-Justine

    Montreal, H3T1C5

  • The Montreal Children's Hospital

    Montreal, H4A 3J1

  • Niagara Clinical Research

    Niagara Falls, L2G 1J4

  • Gordon Sussman Clinical Research, Inc.

    North York

  • Clinique spécialisée en allergie de la capitale

    Québec, G1V 4W2

  • Hospital for Sick Children

    Toronto, M5G 1X8

  • Joel Liem Medicine Professional Corporation

    Windsor, N8X 2G1

Other trials in Canada

Spain6 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, 08950

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, 11407

  • Hospital de Sagunto

    Sagunto, 46520

  • Hospital de Sagunto

    Valencia

  • Hospital la Plana

    Villarreal, 12540

Other trials in Spain

Lithuania5 sites

  • CD8 klinika

    Kaunas, LT-44191

  • Siauliai Republican Hospital

    Šiauliai, LT-76231

  • JSC Seimos gydytojas

    Vilnius, LT-01118

  • Center of Allergy Diagnosis and Treatment

    Vilnius, LT-08109

  • Inlita JSC, Santara KTC

    Vilnius

Other trials in Lithuania

Germany4 sites

  • Kinderarztpraxis Bramsche

    Bramsche, 49565

  • HNO praxis - Dr Yury Yarin

    Dresden, 01139

  • Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

    Frankfurt

  • GMAP/HNO am Neckar

    Heidelberg, 68120

Other trials in Germany

Slovakia4 sites

  • Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie

    Košice

  • Ambulancia klinickej imunologie a alergologie

    Levice, 93501

  • ALFA EL, Imunoalergologická ambulancia

    Poprad, 05801

  • Ambulancia klinickej imunologie a alergologie

    Šurany, 94201

Other trials in Slovakia

France2 sites

  • Hôpital Morvan - Service de Pédiatrie

    Brest

  • CHU de Montpellier - Service Pneumologie et Addictologie

    Montpellier, 34090

Other trials in France

About this study

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

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)

Read the 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.

Being tested
Sublingual allergy immunotherapy tablet, Placebo
Keywords
Allergic rhinitis, HDM, pediatric
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sublingual allergy immunotherapy tabletBiological

    Also called Acarizax, Odactra

    For daily administration (1 tablet per day)

  • PlaceboOther

    Also called Placebo sublingual tablet

    For daily administration (1 tablet per day)

Study groups in NCT04145219
Study groupRoleWhat they receive
Active treatmentExperimentalHDM SLIT-tablet plus allergy and asthma rescue medication
Receives: Biological: Sublingual allergy immunotherapy tablet
PlaceboPlacebo comparatorPlacebo oral tablet plus allergy and asthma rescue medication
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

Secondary outcomes (17)

  1. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  2. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  3. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  4. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  5. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  6. 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.

    Measured: Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment)

  7. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  8. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  9. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  10. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  11. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  12. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  13. 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.

    Measured: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

  14. House Dust Mite Specific IgE

    House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation

    Measured: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)

  15. House Dust Mite Specific IgG4

    House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation

    Measured: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)

  16. Total IgE

    The change in total IgE was measured from screening to the end of trial.

    Measured: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)

  17. 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.

    Measured: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start12 Oct 2019
  3. Primary completion1 Apr 2023
  4. Study completion21 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145219
Sponsor's protocol ID
MT-12
Acronym
MATIC
Status last verified
Jun 2024
First submitted
11 Oct 2019
Last updated
12 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39678704

  • 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.

    PubMed 32548677

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sublingual allergy immunotherapy tablet in people with Allergic Rhinitis Due to Dermatophagoides Farinae and Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, run by ALK-Abelló A/S at 113 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Russia, Ukraine, Poland, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period (time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145219, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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