Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents

Phase 1

Completed

Interventions: Biological: 500 IR house dust mites allergen extract tablet
Biological: 1000 IR house dust mites allergen extract tablet
Biological: 1500 IR house dust mites allergen extract tablet
Biological: Placebo tablet
Biological: SLIT tablets of HDM allergen extracts

Brief Summary: The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.

Recruitment & Eligibility

Inclusion Criteria

Written informed consent from patient and parent(s)/legal representative.
Male or female patient from 12 to 17 years.
Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
Spirometry with best FEV1 > 80% of predicted FEV1.

Exclusion Criteria

Patient with a nasal or oral disease that could interfere with the safety assessments
Patient has undergone recent nasal surgery
Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
Patient with partially controlled or uncontrolled asthma
Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
Female patient pregnant or breast-feeding/lactating.
Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
patient with a history of anaphylaxis
patient having participated in any clinical study within the 12 weeks before visit 1

Arm && Interventions

Group	Intervention	Description
500 IR	500 IR house dust mites allergen extract tablet	500 IR house dust mites allergen extract tablet
1000 IR	1000 IR house dust mites allergen extract tablet	1000 IR house dust mites allergen extract tablet
1500 IR	1500 IR house dust mites allergen extract tablet	1500 IR house dust mites allergen extract tablet
Placebo	Placebo tablet	Placebo tablet
Placebo Sub Lingual Immunotherapy Tablets (SLIT)	SLIT tablets of HDM allergen extracts	Placebo tablets Matching the HDM allergen extract Sub Lingual Immunotherapy Tablets
SLIT of HDM allergen extracts	SLIT tablets of HDM allergen extracts	Sublingual Immunotherapy Tablets of House Dust Mite allergen extracts

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events	10 dosing treatment days	Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent Serious Adverse Events	10 dosing treatment days	Treatment emergent Serious Adverse Events
Adverse Events Leading to Study Withdrawal	10 dosing treatment days	Incidence of adverse events leading to study withdrawal