Adolescent Mite Allergy Safety Evaluation

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/orDermatophagoides farinae at screening
• Lung function measured by Forced expiratory volume in 1 second (FEV1) ≥ 70% ofpredicted value or according to local requirements while on subject's usual asthmamedication
• The subject must be willing and able to comply with trial protocol and adhere to IMPtreatment

Main Exclusion Criteria:

• A subject who has previously been included in studies with the HDM SLIT-tablet, orotherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)
• Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae reaching themaintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment withD. 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 tofirst tablet administration
• Female with positive urine pregnancy test, breastfeeding, pregnant or planning tobecome pregnant within the projected duration of the trial
• Sexually active female of childbearing potential without medically acceptedcontraceptive method