Adolescent Mite Allergy Safety Evaluation
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: HDM SLIT-tablet
Intervention description: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: single-armed
Masking: None (Open Label)
Masking description: Non applicable
Enrollment: 253.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Allergic rhinitis; House dust mite; Adolescent; Pediatric

Summary:

      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.
    

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