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Clinical trial

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

ID
Name
MT-12
Description
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)
Trial arms
Trial start
2019-10-12
Estimated PCD
2023-04-01
Trial end
2023-04-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Sublingual allergy immunotherapy tablet
For daily administration (1 tablet per day)
Arms:
Active treatment
Other names:
Acarizax, Odactra
Placebo
For daily administration (1 tablet per day)
Arms:
Placebo
Other names:
Placebo sublingual tablet
Size
1459
Primary endpoint
Combined rhinitis symptoms and medication use
The last 8 weeks of approximately 12 months of treatment
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double-blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1459, 'type': 'ACTUAL'}}
Updated at
2022-12-12

1 organization

1 product

3 indications

Organization
ALK-Abelló
Product
Sublingual allergy immunotherapy
Indication
House Dust Mite Allergy
Indication
Dermatophagoides Pteronyssinus
Indication
Allergic Rhinitis