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Allergy Immunotherapy

Sublingual allergy immunotherapy tablet for Dust mite allergy (MATIC Trial)

Phase 3
Waitlist Available
Led By Antje Schuster, MD
Research Sponsored by ALK-Abelló A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of imp
Awards & highlights
Pivotal Trial

Summary

This trial tests a tablet that helps children aged 5-11 with house dust mite allergies by gradually exposing them to the allergen. The goal is to reduce their allergic reactions. The study will also check if the treatment is safe and if it improves asthma symptoms and quality of life. These tablets have been shown to improve asthma symptoms and reduce the risk of asthma flare-ups in patients with house dust mite allergies.

Eligible Conditions
  • Dust mite allergy
  • Dust Mite Allergy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of imp
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of imp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period
Secondary study objectives
Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period
Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period
House Dust Mite IgE-Blocking Factor
+14 more

Side effects data

From 2023 Phase 3 trial • 1460 Patients • NCT04145219
58%
Oral pruritus
55%
Throat irritation
33%
Ear pruritus
33%
Abdominal pain upper
25%
Nasopharyngitis
21%
Lip swelling
20%
Glossodynia
19%
Nausea
17%
Taste disorder
14%
Mouth swelling
14%
Swollen tongue
13%
Diarrhoea
13%
Mouth ulceration
9%
Pharyngeal swelling
7%
Tongue ulceration
7%
Vomiting
6%
Tooth loss
5%
Pharyngitis
5%
Bronchitis
5%
COVID-19
3%
Upper respiratory tract infection
2%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
HDM SLIT-tablet (12 SQ-HDM)
Placebo SLIT-tablet

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active treatmentExperimental Treatment1 Intervention
HDM SLIT-tablet plus allergy and asthma rescue medication
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral tablet plus allergy and asthma rescue medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sublingual allergy immunotherapy tablet
2019
Completed Phase 3
~1460

Find a Location

Who is running the clinical trial?

ALK-Abelló A/SLead Sponsor
76 Previous Clinical Trials
326,948 Total Patients Enrolled
Antje Schuster, MDPrincipal InvestigatorProfessor of Pediatrics, Düsseldorf University Hospital
~240 spots leftby Nov 2025
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