Clinical trial to assess the efficacy and safety of a vaccine for dust mite and Lepidoglyphus destructor allergy.

INTERVENTION: Product Name: Dermatophagoides/L. destructor 30,000/30,000 TU/mL suspension for injection, Product Code:PRD13483418, Pharmaceutical Form: SOLUTION FOR SKIN PRICK TEST, Other descriptive name: , Strength: , Product Name: Same solution and presentation that active treatment but without active ingredients, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A CONDITION: Aetiological treatment of moderate‐to‐severe allergic rhinitis/rhinoconjunctivitis with or without mild‐to‐moderate controlled allergic asthma ; MedDRA version: 20.0Level: LLTClassification code: 10020419Term: House dust mite allergy Class: 10021428 ; MedDRA version: 21.1Level: LLTClassification code: 10001705Term: Allergic asthma Class: 10038738 ; MedDRA version: 20.0Level: LLTClassification code: 10001728Term: Allergic rhinoconjunctivitis Class: 10015919 ; MedDRA version: 28.1Level: LLTClassification code: 10034382Term: Perennial allergic rhinitis Class: 10038738 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: The primary objective of this trial is to evaluate the clinical efficacy of the investigational medicinal product (IMP) at 30,000/30,000 TU/mL, administered subcutaneously, compared with placebo, in participants aged 12 to 65 years with moderate‐to‐severe persistent rhinitis/rhinoconjunctivitis with or without controlled intermittent or persistent mild‐to‐moderate asthma, allergic to Dermatophagoides and Lepidoglyphus destructor. Primary end point(s): Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) assessed over 4 weeks after one year of treatment, recorded using the Participant´s Diary Secondary Objective: To evaluate the clinical efficacy of glutaraldehyde‐polymerized allergen extracts compared with placebo using the mean daily score (RCSMS) adjusted for baseline values., To evaluate the safety and clinical tolerability of glutaraldehyde‐polymerized allergen extracts., To evaluate the clinical benefit of glutaraldehyde‐polymerized allergen extracts accross different efficacy parameters compared with placebo and baseline., To evaluate the effect of glutaraldehyde‐polymerized allergen extracts on the immunological status of participants compared with placebo and baseline., To evaluate the clinical effect of glutaraldehyde‐polymerized allergen extracts on quality of life and symptom control compared with placebo and baseline., To evaluate the effect of glutaraldehyde‐polymerized allergen extracts on healthcare resource utilization related to the study pathologies and the baseline situation. SECONDARY OUTCOME: Secondary end point(s):Allergen profiling (ALE Xtechnique) Secondary end point(s):Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS) Secondary end point(s):Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) Secondary end point(s):Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) Secondary end point(s):Asthma Control Questionnaire (ACQ‐6) Secondary end point(s):Asthma exacerbations: time to first asthma exacerbation; number, duration, and severity Secondary end point(s):Asthma Medication Score (AMS) Secondary end point(s):Asthma Quality of Life Questionnaire (AQLQ) Secondary end point(s):Asthma Symptom Score (ASS) Secondary end point(s):Asthma‐Combined Symptom and Medication Score (ACSMS) Secondary end point(s):Consumption of Health Resources Secondary end point(s):Immunological parameters*: o Total IgE o Specific IgE and IgG4 o Specific IgE/Total IgE ratio * Immunological parameters and allergen profiling (ALE Xtechnique) will be carried out at Inmunotek or by an external laboratory contracted by the sponsor. Secondary end point(s):Rhinitis/Rhinoconjunctivitis Medication Score (RMS) Secondary end point(s):Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) Secondary end point(s):Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Secondary end point(s):Safety parameters: o Overall rate and severity of adverse events (AEs) per administration and per subject. o Evaluation of reactions at the site of administration, systemic reactions and of any medications administered for the treatment of the adverse reaction (AR). Secondary end point(s):Visual Analogue Scale (VAS) INCLUSION CRITERIA: Participants who have signed the informed consent form., Participants capable of complying with the dosing regimen., Participants capable of recording symptoms and medication use in an electronic diary via a smartphone (preferably) or in a paper diary., Participants with a Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) = 2 out of 6, recorded for at least 10 days, corresponding to moderate‐to‐severe allergic rhinitis/rhinoconjunctivitis., Male or female participants aged 12 to 65 years, inclusive., Participants with a confirmed clinical history of inhalant allergy with moderate‐to‐severe persistent rhinitis/rhinoconjunctivitis according to ARIA classification (1) of at least 1 year duration (treated with antiallergic medication) with or without controlled intermittent or persistent mild‐to‐moderate asthma according to the definition of GEMA 5.5, (2) caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Lepidoglyphus destructo