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EVALUATION OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNOTHERAPY (BELTAVAC®) WITH POLYMERIZED ALLERGENIC EXTRACT OF HOUSE DUST MITE MIXTURE IN PATIENTS WITH ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS
EU CTIS ID: 2024-516893-31-01
What this study is testing
To assess the efficacy of the subcutaneous rush immunotherapy with Beltavac® for 12 months for treating HDM-sensitized allergic rhinitis
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For the screening phase. 1. Written informed consent, signed and dated. 2. Male or female between 12 and 65 years of age (both included). 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). 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. 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. 6. Patients who are willing and able to complete an electronic patient record during the 4-week screening period.
- For the treatment phase 1. Negative pregnancy test. 2. Combined symptom and medication score (ESMR4) ≥ 1.5 during the screening phase. 3. Patients willing and able to complete an electronic patient record for a 12-week period during the treatment phase. 4. Asthma Control Test (ACT) score >19 (for asthmatic patients only). 5. PEF value >80% of personal best at the time of the visit (for asthmatic patients only).
You likely can't join if
- 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. 2. Poorly controlled asthma according to the GEMA 5.0 guide (Figure 2). 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. 4. Autoimmune diseases or immunodeficiency. 5. Malignant neoplasms, severe cardiovascular diseases, severe mental illnesses or other relevant chronic diseases that may interfere with the results of the study. 6. Clinical history of anaphylaxis with cardio/respiratory symptoms. 7. Hypersensitivity to any of the excipients of the investigational product. 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. 9. Treatment with beta-blockers during the study. 10. Patients who have previously received immunotherapy with dust mite allergen extract or other extracts and who have failed during the last 5 years. 11. Patients with immunotherapy with allergens other than dust mites during the study period. 12. Patients who receive any other vaccine one week before starting treatment or waiting for the second dose of the COVID-19 vaccine. 13. Pregnant or breastfeeding patients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.