DERMATOPHAGOIDES PTERONYSSINUS for Allergies

Inclusion criteria

• {"criterion_text":"- 1st PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).\n- 2nd PHASE: To determine the sensitivity of the extract: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus allergen and/or any allergen from its homologous group (Dermatophagoides farinae), meeting both of the following criteria: 1. Positive skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher.mm larger than that produced by the negative control used in the diagnostic battery. 2. Positive specific IgE (in vitro diagnostic test) class 1 or higher.\n- 2nd PHASE : To determine the specificity of the extract: Patient in whom possible IgE-mediated sensitization to Dermatophagoides pteronyssinus or any allergen from its homologous group (Dermatophagoides farinae) has been ruled out, meeting both of the following criteria: 1. Negative skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Negative specific IgE (in vitro diagnostic test).\n- 2nd PHASE: The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate.\n- 2nd PHASE: Mean wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).\n- 2nd PHASE: Mean wheal diameter < 3 mm induced by the negative control.\n- 1st PHASE: Age between 18 and 50 years, regardless of gender.\n- 1st PHASE: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus allergen, meeting both of the following criteria: 1. Skin prick test with a wheal diameter at least ≥ 3 mm larger than that produced by the negative control used in the diagnostic panel. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher.\n- 1st PHASE: Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).\n- 1st PHASE: The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate\n- 2nd PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus and/or Dermatophagoides farinae is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).\n- 2nd PHASE: Age between 18 and 50 years, regardless of sex."}

Exclusion criteria

• {"criterion_text":"- 1st and 2nd PHASE: That the patient has received treatment with specific immunotherapy with an extract of the allergen to be standardized and/or with other allergen(s) that may interfere with skin reactivity to the extract to be standardized (cross-reactivity/homologous groups) in the last 5 years.\n- 1st and 2nd PHASE: The administration of drugs capable of interfering with the results of the SPT, including antihistamines (H1 and H2 blockers) or cromoglycate, which cannot be discontinued for the skin tests.\n- 1st and 2nd PHASE: That the patient has lesions or tattoos on the skin area where the tests will be performed, and at the time of the tests, these could influence the proper evaluation of the same.\n- 1st and 2nd PHASE: Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), dermatographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests for standardization should be performed.\n- 1st and 2nd PHASE : Patient's inability to understand the objective/purpose of the study.\n- 1st and 2nd PHASE: Patient's inability/refusal to sign the informed consent for participation in the study.\n- 1st and 2nd PHASE: Hypersensivity to any of the excipients in the investigational product.\n- 1st and 2nd PHASE: Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, as well as chronic treatment with tricyclic antidepressants and/or systemic corticosteroids (not inhaled)."}

Primary endpoints

• {"endpoint_text":"- The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.","definition_or_measurement_approach":"Measurement: area of the wheal (mm2) produced on skin after administration of extracts in prick test."}
• {"endpoint_text":"- Estimation of the dose/response relationship in each patient; regression analysis of area values ​​versus concentration in PNU/ml.","definition_or_measurement_approach":"Measurement: regression analysis of area values versus concentration expressed in PNU/ml to estimate dose–response relationship per patient."}
• {"endpoint_text":"- Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml","definition_or_measurement_approach":"Measurement: determine theoretical extract concentration that yields papule equivalent to histamine 10 mg/ml (comparison to positive control)."}

Secondary endpoints

• {"endpoint_text":"- Evaluation of the sensitivity and specificity of the extract concentration defined in the main objective of the study.","definition_or_measurement_approach":"Measurement: assess sensitivity and specificity of the defined extract concentration (likely via comparison of positive/negative SPT and specific IgE results)."}
• {"endpoint_text":"- Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study","definition_or_measurement_approach":"Measurement: descriptive analysis of adverse reactions recorded during study conduct."}

Spain

Earliest CTIS Part Ii Submission Date

12-07-2024

Latest Decision Or Authorization Date

09-09-2024

Processing Time Days

59

Number Of Sites

2

Number Of Participants

96

Primary sponsor

Full Name

Advanced Outcomes Research S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Co-sponsors

• Asac Pharmaceutical Inmunology S.A.