Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM

Launched by PROBELTE PHARMA S.L.U. · May 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Beltavac, which uses a special extract from house dust mites, to see how well it works and how safe it is for people with house dust mite allergies. The study is focused on individuals who have moderate to severe allergy symptoms affecting their nose and eyes, known as allergic rhinoconjunctivitis, and may also have asthma. Researchers want to find out if this treatment can help reduce these symptoms and improve the quality of life for participants.

To be eligible for the trial, participants need to be between 12 and 65 years old and must have recently tested positive for a house dust mite allergy. They should experience persistent allergy symptoms and have asthma that is well controlled or only partially controlled. Participants will need to sign a consent form and will be closely monitored throughout the study. It's important to note that individuals with severe asthma, certain other health conditions, or those who are pregnant or nursing cannot take part in this trial. If you qualify and decide to participate, you may have a chance to help researchers understand how to better treat house dust mite allergies.

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Eligibility criteria

• Inclusion Criteria:
• • Written informed consent, signed and duly dated.
• • Man or woman between 12 and 65 years old (both included).
• • Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
• • Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (\> 3.5 kU / L) within the 6 months prior to the study.
• • Negative pregnancy test.
• • Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.
• Exclusion Criteria:
• • Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
• • Poorly controlled asthma according to the GEMA 5.0 guideline
• • Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
• • Autoimmune diseases or immunodeficiency.
• • Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
• • Clinical history of anaphylaxis with cardio / respiratory symptoms.
• • Hypersensitivity to any of the excipients of the investigational product.
• • Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.
• • Treatment with beta-blockers during the study.
• • Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.
• • Patients with immunotherapy with allergens other than dust mites during the study period.
• • Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19.
• • Pregnant or nursing patients.