Assessing the effectiveness and safety of Beltavac for house dust mite allergy
Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis
This study is testing if a new treatment called Beltavac can help people aged 12 to 65 with house dust mite allergies feel better and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Probelte Pharma S.L.U. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 18 sites (Orihuela, Alicante and 17 other locations) |
| Trial ID | NCT05395689 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Beltavac, a treatment derived from polymerized extracts of house dust mites, in patients suffering from allergic rhinoconjunctivitis, with or without asthma. Participants aged 12 to 65 with moderate to severe persistent rhinitis symptoms will be enrolled, and their response to the treatment will be compared to a placebo. The study aims to confirm the treatment's effectiveness in alleviating allergy symptoms and improving quality of life for affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 to 65 with moderate to severe symptoms of persistent rhinitis and confirmed sensitization to house dust mites.
Not a fit: Patients with poorly controlled asthma or significant sensitization to other allergens may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce allergy symptoms and improve the quality of life for patients with house dust mite allergies.
How similar studies have performed: Previous studies have shown promise in using allergenic extracts for treating similar allergic conditions, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orihuela, Alicante and 17 other locations
- Hospital Vega Baja — Orihuela, Alicante, Spain (Recruiting)
- Hospital General de Granollers — Granollers, Barcelona, Spain (Recruiting)
- Hospital de Canarias — Santa Cruz de Tenerife, Canary Islands, Spain (Withdrawn)
- Hospital de la Plana — Castellon, Castellón, Spain (Recruiting)
- Hospital Regional de Málaga — Málaga, Málaga, Spain (Recruiting)
- Complejo Hospitalario de Navarra — Pamplona, Navarre, Spain (Recruiting)
- Fundacion Sanitaria Sant Pere Claver — Barcelona, Spain (Recruiting)
- Hospital de Bellvitge — Barcelona, Spain (Recruiting)
- Hospital Germans Trias i Pujol — Barcelona, Spain (Recruiting)
- Hospital infantil Vall d Hebron — Barcelona, Spain (Recruiting)
- Hospital Val d ' Hebron — Barcelona, Spain (Recruiting)
- Hospital General de Castellón — Castelló, Spain (Recruiting)
- Hospital Virgen de la Arrixaca — Murcia, Spain (Withdrawn)
- Hospital de Fatima — Seville, Spain (Recruiting)
- Hospital Virgen Macarena — Seville, Spain (Recruiting)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (Recruiting)
- Hospital Politecnico de la Fé — Valencia, Spain (Recruiting)
- Hospital Universitario Infantil de la Fé — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Inma Buendia
- Email: inmaculadabuendia@probeltepharma.es
- Phone: +34 608 933 618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.