2024-516893-31-01招募中3 期
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
Probelte Pharma S.L.14 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年10月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- 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.
研究概览
简要总结
To assess the efficacy of the subcutaneous rush immunotherapy with Beltavac® for 12 months for treating HDM-sensitized allergic rhinitis
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •For the screening phase.
- •Written informed consent, signed and dated.
- •Male or female between 12 and 65 years of age (both included).
- •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.
- •(Figure 2).
- •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.
- •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.
- •Patients who are willing and able to complete an electronic patient record during the 4-week screening period.
- •For the treatment phase
- •Negative pregnancy test.
- •Combined symptom and medication score (ESMR4) ≥ 1.5 during the screening phase.
- •Patients willing and able to complete an electronic patient record for a 12-week period during the treatment phase.
- •Asthma Control Test (ACT) score >19 (for asthmatic patients only).
- •PEF value >80% of personal best at the time of the visit (for asthmatic patients only).
排除标准
- •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.
- •Poorly controlled asthma according to the GEMA 5.0 guide (Figure 2).
- •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.
- •Autoimmune diseases or immunodeficiency.
- •Malignant neoplasms, severe cardiovascular diseases, severe mental illnesses 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 (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.
- •Treatment with beta-blockers during the study.
- •Patients who have previously received immunotherapy with dust mite allergen extract or other extracts and who have failed during 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 starting treatment or waiting for the second dose of the COVID-19 vaccine.
- •Pregnant or breastfeeding patients.
结局指标
主要结局
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.
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.
次要结局
- - Nasal symptom scale score (SS4). - Specific medication scale score (MS). - Nasal and ocular symptom scale score (SS6) - Combined nasal, ocular symptom and medication scale score (CSMS6). - Percentage of days without symptoms or medication.
研究者
Inmaculada Buendía Jiménez
Scientific
Probelte Pharma S.L.
研究点 (14)
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