Clinical trial
A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
Name
MT-18
Description
This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
Trial arms
Trial start
2020-09-23
Estimated PCD
2021-04-24
Trial end
2021-04-24
Status
Completed
Phase
Early phase I
Treatment
HDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Arms:
HDM SLIT Tablet
Other names:
ACARIZAX, ODACTRA
Size
253
Primary endpoint
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Number of Treatment-emergent Adverse Events (TEAEs)
From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days.
Eligibility criteria
Inclusion Criteria:
* Written informed consent
* Male or female subjects aged ≥12 to ≤17 years
* A clinical history of allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM
* Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening
* Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value or according to local requirements while on subject's usual asthma medication
* The subject must be willing and able to comply with trial protocol and adhere to IMP treatment
Main Exclusion Criteria:
* A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)
* Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1
* Ongoing treatment with any allergy immunotherapy product at screening
* Severe chronic oral inflammation
* A diagnosis or history of eosinophilic oesophagitis
* Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration
* Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial
* Sexually active female of childbearing potential without medically accepted contraceptive method
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-armed', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Non applicable'}}, 'enrollmentInfo': {'count': 253, 'type': 'ACTUAL'}}
Updated at
2023-07-03
1 organization
1 product
2 indications
Organization
ALK-AbellóProduct
HDM SLITIndication
Allergic RhinitisIndication
Allergic Rhinoconjunctivitis