A multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of a subcutaneous allergoid preparation of house dust mite allergens (Dermatophagoides pteronyssinus / Dermatophagoides farinae) in patients with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic asthma.

House dust mite allergy

Adapted Rhinitis Combined Symptom and Medication Score (arCSMS) over the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approx. 12 months), comparing active IMP with placebo. The arCSMS is defined as the average sum of the daily Rhinitis Symptom Score (rSS) and the daily Rhinitis Medication Score (rMS).

Mean daily rhinitis symptom score (rSS) over the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approx. 12 months), Change from the arCSMS over the 2 week Baseline Evaluation Phase to the arCSMS over the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approximately 12 months), Response to treatment defined as an improvement of least 0.22 points in the arCSMS between the Baseline and the Efficacy Evaluation Phase, Mean daily rhinitis medication score (rMS) over the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approx. 12 months), Mean rTCS over the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approx. 12 months), Proportion of rhinitis symptom-free days (daily rhinitis symptom score = 0) and rhinitis medication-free days (daily rhinitis medication score = 0) during the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approx. 12 months), Mean conjunctivitis combined symptom and medication score (cCSMS) over the 4-week Efficacy Evaluation Phase following the final administration of study treatment (approx. 12 months), Change from baseline to the end of treatment in the RQLQ total scores., The physician rated clinical global improvement (CGI-I) from baseline to after treatment (at final visit), Similarly, the patient-rated global impression improvement (PGI-I) from baseline to after treatment (at final visit)., Change from baseline to end of treatment in HDM-specific IgE and IgG4 levels to D. pteronyssinus and D. farinae., Number, incidence, time of onset, type and intensity of AEs and serious adverse events (SAE) according to MedDRA primary system organ class (SOC) and preferred term (PT), Number, incidence, time of onset, type and intensity of AEs and serious adverse events assessed as IMP-related (by investigator) according to MedDRA primary SOC and PT, Incidence and intensity of systemic allergic reactions after injections according to the World Allergy Organization (WAO) grading system., Number of patients reaching the maintenance phase without dose adjustment due to adverse events, Change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase, Change of vital signs and lung function measured before and after the treatment phase, Assessment of the overall tolerability by the investigator and the patient using a 5-point Likert scale

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