mixture of allergen extracts of dermatophagoides pteronyssinus and dermatophagoides farinae polymerized with glutaraldehyde for Allergic rhinoconjunctivitis due to house dust mite | House dust mite allergy

Inclusion criteria

• {"criterion_text":"- For the screening phase. 1. Written informed consent, signed and dated."}
• {"criterion_text":"- 2. Male or female between 12 and 65 years of age (both included)."}
• {"criterion_text":"- 3. Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide (Figure 1) associated or not with asthma well or partially controlled according to the GEMA Guide 5.0. (Figure 2)."}
• {"criterion_text":"- 4. Confirmation of sensitization to DPT or DF with a positive prick test (mean diameter of the wheal greater than or equal to 3 mm) with a standardized commercial allergenic extract and a serum extract-specific IgE value of class 3 or higher (>3.5 kU/L) within 6 months prior to the study."}
• {"criterion_text":"- 5. For women with the possibility of pregnancy, use of contraception for at least 1 month prior to the visit and commitment to continue using it during the period of participation in the trial."}
• {"criterion_text":"- 6. Patients who are willing and able to complete an electronic patient record during the 4-week screening period."}
• {"criterion_text":"- For the treatment phase 1. Negative pregnancy test."}
• {"criterion_text":"- 2. Combined symptom and medication score (ESMR4) ≥ 1.5 during the screening phase."}
• {"criterion_text":"- 3. Patients willing and able to complete an electronic patient record for a 12-week period during the treatment phase."}
• {"criterion_text":"- 4. Asthma Control Test (ACT) score >19 (for asthmatic patients only)."}
• {"criterion_text":"- 5. PEF value >80% of personal best at the time of the visit (for asthmatic patients only)."}

Exclusion criteria

• {"criterion_text":"- 1. Concomitant sensitization to allergens other than dust mites in case clinically relevant symptoms are expected that may interfere with the evaluation periods of the study (4 weeks before visits V1, V7, V10 and V13) according to the investigator's criteria. Clarification: The inclusion/exclusion of patients sensitized to other perennial allergens (other than Dermatophagoides), such as storage mites and fungi, will be evaluated by the PI and agreed with the scientific committee of the trial based on the clinical and IgE values ​​of each patient."}
• {"criterion_text":"- 2. Poorly controlled asthma according to the GEMA 5.0 guide (Figure 2)."}
• {"criterion_text":"- 3. Severe asthma, that is, those who have controlled their asthma during the last few months according to therapeutic step 5-6 of the GEMA 5.0 Guide."}
• {"criterion_text":"- 4. Autoimmune diseases or immunodeficiency."}
• {"criterion_text":"- 5. Malignant neoplasms, severe cardiovascular diseases, severe mental illnesses or other relevant chronic diseases that may interfere with the results of the study."}
• {"criterion_text":"- 6. Clinical history of anaphylaxis with cardio/respiratory symptoms."}
• {"criterion_text":"- 7. Hypersensitivity to any of the excipients of the investigational product."}
• {"criterion_text":"- 8. Immunosuppressive medication (e.g. cyclosporine A, azathioprine, omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) during the last 6 months prior to patient inclusion and until the end of the study."}
• {"criterion_text":"- 9. Treatment with beta-blockers during the study."}
• {"criterion_text":"- 10. Patients who have previously received immunotherapy with dust mite allergen extract or other extracts and who have failed during the last 5 years."}
• {"criterion_text":"- 11. Patients with immunotherapy with allergens other than dust mites during the study period."}
• {"criterion_text":"- 12. Patients who receive any other vaccine one week before starting treatment or waiting for the second dose of the COVID-19 vaccine."}
• {"criterion_text":"- 13. Pregnant or breastfeeding patients."}

Primary endpoints

• {"endpoint_text":"- Score on the combined scale of nasal symptoms and specific medication (CSMS4) of allergy completed by the patient daily in his/her online patient card in periods of 4 weeks repeatedly during the year of follow-up.","definition_or_measurement_approach":"Patient-completed CSMS4 (combined nasal symptoms and specific medication) recorded daily in the online patient card in 4-week periods repeated during 12 months of follow-up."}

Secondary endpoints

• {"endpoint_text":"- Nasal symptom scale score (SS4).","definition_or_measurement_approach":"Score on the nasal symptom scale (SS4) as recorded in patient assessments."}
• {"endpoint_text":"- Specific medication scale score (MS).","definition_or_measurement_approach":"Score on the specific medication scale (MS) as recorded in patient assessments."}
• {"endpoint_text":"- Nasal and ocular symptom scale score (SS6)","definition_or_measurement_approach":"Score on the nasal and ocular symptom scale (SS6) as recorded in patient assessments."}
• {"endpoint_text":"- Combined nasal, ocular symptom and medication scale score (CSMS6).","definition_or_measurement_approach":"Score on the combined nasal, ocular symptom and medication scale (CSMS6) as recorded in patient assessments."}
• {"endpoint_text":"- Percentage of days without symptoms or medication.","definition_or_measurement_approach":"Proportion/percentage of days during assessment periods when the patient reports no symptoms and no medication use."}

Spain

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

2

Number Of Sites

16

Number Of Participants

250

Primary sponsor

Full Name

Probelte Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain