Adolescent Mite Allergy Safety Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.

Official Title
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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

Conditions
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Allergic Rhinitis, Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: HDM SLIT-tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-armed
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HDM SLIT Tablet<br>House dust mite (HDM) Sublingual allergy immunotherapy tablet | Biological: HDM SLIT-tablet<br>* Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)<br>* Other names: ACARIZAX, ODACTRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | At least one 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) | At least one 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) | At least one TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | At least one solicited 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 Solicited Treatment-emergent Adverse Event (TEAE) | At least one solicited TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 
| Number of Solicited Treatment-emergent Adverse Events (TEAEs) | At least one solicited TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 
| Number of Subjects With at Least One IMP-related Adverse Event (AE) | At least one IMP-related AE | 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 IMP-related Adverse Event (AE) | At least one IMP-related AE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 
| Number of IMP-related Adverse Events (AEs) | At least one IMP-related AE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 
| Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | At least one treatment-emergent SAE | 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 Serious Adverse Event (SAE) | At least one treatment-emergent SAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 
| Number of Treatment-emergent Serious Adverse Events (SAEs) | At least one treatment-emergent SAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, House dust mite, Adolescent, Pediatric