Mite Asthma Pediatric Immunotherapy Trial

Inclusion Criteria:

• Written informed consent
• Male or female of any race/ethnicity aged 5-17 years
• A female subject of childbearing potential must have a negative pregnancy test and bewilling to practise appropriate contraceptive methods
• A clinical history of HDM allergic asthma
• Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with orwithout LABA for the control of asthma symptoms
• A clinical history of asthma exacerbations in the past two years
• One or more of the following within the past 4 weeks prior to randomisation:
• Daytime asthma symptoms more than twice/week
• Any nocturnal awakening due to asthma
• SABA rescue medication needed for treatment of asthma symptoms
• Any activity limitation due to asthma
• Lung function measured by FEV1 ≥ 70% of predicted value or according to localrequirements
• Clinical history of HDM AR within the last year prior to randomisation
• An average TCRS>0 during the baseline period
• Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinusand/or D. farinae at screening
• Positive SPT to D. pteronyssinus and/or D. farinae at screening
• Subject willing and able to comply with trial protocol

Exclusion Criteria:

• Is sensitised and regularly exposed to animal dander, molds, and/or cockroach or otherperennial allergen
• Has experienced a life-threatening asthma attack
• Within the last month before the randomisation visit (visit 3), has had an occurrenceof any clinical deterioration of asthma that resulted in emergency treatment,hospitalisation, or treatment with systemic corticosteroids
• Within the last 3 months before the randomisation visit (visit 3) while on high doseICS treatment, has had an occurrence of any clinical deterioration of asthma thatresulted in emergency treatment, hospitalisation, or treatment with systemiccorticosteroids
• Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12months
• Ongoing treatment with any allergy immunotherapy product
• Any clinically relevant condition or chronic disease incl. malignancy that in theopinion of the investigator would interfere with the trial evaluations or the safetyof the subject
• Has a diagnosis of eosinophilic oesophagitis
• A relevant history of systemic allergic reactions
• Ongoing treatment with OCS
• Treatment with restricted and prohibited concomitant medication
• Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening
• A history of allergy, hypersensitivity or intolerance to any of the excipients oractive substance of the IMP (except D. pteronyssinus and D. farinae) or to anyexcipient of the rescue medication provided in this trial
• A business or personal relationship with trial staff or sponsor who is directlyinvolved with the conduct of the trial
• A history of alcohol or drug abuse
• Has previously been randomised into this trial, is participating in this trial atanother investigational site or is participating or planning to participate in anyother clinical trial during the duration of this trial
• Has a history or current evidence of any condition, treatment, laboratory values outof range or other circumstance that in the opinion of the investigator are clinicallyrelevant and might expose the subject to risk by participating in the trial, confoundthe results of the trial, or interfere with the subject's participation for the fullduration of the trial
• Has a condition or treatment that increase the risk of the subject developing severeadverse reactions after adrenaline/epinephrine administration
• Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectorsfor countries where this is a regulatory requirement