Dermatophagoides pteronyssinus; Dermatophagoides farinae for Allergic rhinitis/rhinoconjunctivitis due to house dust mite (Dermatophagoides)

Inclusion criteria

• {"criterion_text":"- Age between 14 and 50 years."}
• {"criterion_text":"- Diagnosis of allergic rhinitis with or without conjunctivitis, with or without associated asthma. In patients with associated asthma at the time of recruitment, FEV₁ must be >70% of predicted and FVC >80% of predicted"}
• {"criterion_text":"- Positive skin prick test results to D. pteronyssinus and D. farinae, with a mean wheal diameter at least 5 mm greater than the negative control. The skin prick test is considered valid if performed within 12 months prior to study inclusion"}
• {"criterion_text":"- Specific IgE to D. pteronyssinus and D. farinae ≥ 0.70 kU/L. This determination is considered valid if performed within 6 months prior to study inclusion"}
• {"criterion_text":"- Positive result in the nasal provocation test using a maximum concentration of 1/10"}
• {"criterion_text":"- Signed informed consent to participate in the study"}
• {"criterion_text":"- For women of childbearing potential (defined as the time from menarche to postmenopause, unless rendered sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy): confirmation of non-pregnancy at the time of study entry, verified by a negative urine pregnancy test. An additional pregnancy test will be performed at the end of treatment to confirm absence of pregnancy"}
• {"criterion_text":"- No previous or concomitant allergen immunotherapy with Dermatophagoides extract or with any other allergen during the study period"}

Exclusion criteria

• {"criterion_text":"- Sensitization (by skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites), or any other allergen source (according to the geographical location of each participating center), that could interfere with the patient's clinical course during the follow-up period of this clinical trial. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid"}
• {"criterion_text":"- Sensitization (by skin prick test and/or specific IgE) to seasonal allergens that, due to their particular seasonal characteristics and their geographical prevalence in the location of the participating centers, could interfere with the clinical course of enrolled patients during the study period. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid."}
• {"criterion_text":"- Recent nasal/oral surgery (within the last 6 months, and within the last 2 months in the case of dental extractions, dental implants, or similar procedures)."}
• {"criterion_text":"- Nasal septum perforation."}
• {"criterion_text":"- Partially controlled or uncontrolled bronchial asthma according to GINA criteria. The following will be considered exclusion criteria: •\tFEV₁ ≤ 70% of predicted, and •\tFVC ≤ 80% of predicted, and •\tContinuous use of asthma medication corresponding to GINA treatment steps 3, 4, or 5."}
• {"criterion_text":"- Usual contraindications for allergen immunotherapy: •\tActive or controlled neoplastic disease, or a diagnosis of neoplastic disease within the last 5 years. •\tAcute psychiatric disorder that significantly limits the patient’s daily functioning. •\tPregnancy and breastfeeding."}
• {"criterion_text":"- Chronic use of medications that may interfere with proper analysis and monitoring during the study: antihistamines, oral and/or parenteral corticosteroids, mast cell stabilizers (e.g., cromoglycates), antidepressants"}
• {"criterion_text":"- Refusal to participate in the trial or to sign the informed consent form."}

Primary endpoints

• {"endpoint_text":"- The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a rhinomanometer provided by the sponsor, and the response will be considered positive if the NIPF decreases by ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptom scores on a 13-point scale.","definition_or_measurement_approach":"Change in Nasal Inspiratory Peak Flow (NIPF) measured using a sponsor-provided rhinomanometer; response considered positive if NIPF decreases by ≥ 40%. Additionally, clinical assessment via total symptom score on a 13-point scale."}

Secondary endpoints

• {"endpoint_text":"- Assessment of rescue medication use throughout the study in relation to the investigational product/placebo.","definition_or_measurement_approach":"Assessment (use and amount) of rescue medication during study period in relation to assigned investigational product or placebo."}
• {"endpoint_text":"- Evaluation of adverse reactions occurring during the patient follow-up period specified in the study.","definition_or_measurement_approach":"Collection and evaluation of systemic and local adverse reactions reported during the follow-up period, excluding reactions from nasal provocation test or skin prick test."}
• {"endpoint_text":"- Analytical determinations of serum markers (specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, Der p1 and Der p2; and IgG4 to Dermatophagoides) at baseline and at the end of the study.","definition_or_measurement_approach":"Serological measurements of specific IgE (D. pteronyssinus, D. farinae, Der p1, Der p2) and IgG4 at baseline and at study end; determinations performed at centralized laboratory (Echevarne Laboratory)."}
• {"endpoint_text":"- Assessment of the primary wheal resulting from skin prick tests with Dermatophagoides pteronyssinus and Dermatophagoides farinae at baseline and at the end of the study: the primary wheal will be calculated as the mean of the two diameters ([largest diameter + smallest diameter] / 2). Subsequently, the group mean will be calculated based on the results of each enrolled subject, to allow for comparative analysis between groups.","definition_or_measurement_approach":"Primary wheal calculated as mean of two diameters ([largest + smallest]/2) for each subject at baseline and study end; group means calculated for comparative analysis."}
• {"endpoint_text":"- Evaluation of all individual variables from the scoring scale used in the nasal provocation test.","definition_or_measurement_approach":"Independent analysis of each variable included in the nasal provocation test scoring scale."}

Spain

Earliest CTIS Part Ii Submission Date

28-08-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

211

Number Of Sites

13

Number Of Participants

120

Primary sponsor

Full Name

Asac Pharmaceutical Inmunology S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Co-sponsors

• Advanced Outcomes Research S.L.