Buendía-Jiménez Inmaculada, Matas-Ros María, Garriga-Baraut Teresa, Roger-Reig Albert, Tabar-Purroy Ana
Medical Affairs Department, Probelte Pharma, Murcia, Spain.
Pediatric Allergy Unit. Vall d'Hebron Universitary Hospital, Barcelona, Spain.
Trials. 2025 May 28;26(1):176. doi: 10.1186/s13063-025-08875-x.
There is an important heterogeneity of the clinical research done to date for allergen immunotherapy (AIT). We plan to assess the safety and efficacy of a house dust mite (HDM) polymerized allergen extract mixture for allergic rhinoconjunctivitis (AR) according to both the EMA and European Academy of Allergy and Clinical Immunology (EAACI) guidelines for the clinical development of products for the treatment of AR.
We will perform a double-blind, placebo-controlled, randomized parallel group phase III clinical trial to assess the clinical efficacy and safety of a polymerized Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract mixture (Beltavac®) to treat perennial AR in children and adults. Patients with moderate or severe rhinitis symptoms, either associated or not with asthma and confirmed HDM sensitization and without relevant concomitant conditions that may interfere with the planned evaluations test are eligible. Patients will be randomized in a 1:1 ratio to either the active AIT or placebo. The experimental group will receive 12 monthly AIT doses via subcutaneous route with a potency of 2 RC/ml per allergen. The expected sample size is 250 patients from 16 sites in Spain. The main efficacy outcome is the Combined Symptom and Medication Score (CSMS) for rhinitis. It will be patients' self-assessed and collected through a phone App developed ad hoc for the study to improve the patient adherence and the quality of data. Main secondary outcomes include expanded CSMS for rhinoconjunctivitis symptoms, control of rhinitis, specific IgE and IgG values, quality of life, and the number of adverse reactions. Health-related direct and indirect costs will be also evaluated. Finally, several exploratory parameters will be used to assess the severity of asthma.
This phase III clinical trial will be of interest to contribute to the scientific evidence about the efficacy and safety of AIT with allergoids. Our working hypothesis is that the investigational product in patients with AR associated or not with asthma is superior to placebo in providing a clinically significant improvement according to the standards defined by the EAACI. This trial will also supply valuable information about patients reported outcomes using health technology for rhinoconjunctivitis and asthma assessment.
EudraCT 2018-003427-11. Date on which this record was first entered in the: 2021-06-14.
迄今为止，变应原免疫疗法（AIT）的临床研究存在重要的异质性。我们计划根据欧洲药品管理局（EMA）和欧洲变态反应与临床免疫学会（EAACI）关于治疗变应性鼻炎（AR）产品临床开发的指南，评估一种用于治疗变应性鼻结膜炎（AR）的屋尘螨（HDM）聚合变应原提取物混合物的安全性和有效性。
我们将进行一项双盲、安慰剂对照、随机平行组III期临床试验，以评估一种聚合的粉尘螨和户尘螨变应原提取物混合物（Beltavac®）治疗儿童和成人常年性AR的临床疗效和安全性。有中度或重度鼻炎症状、伴有或不伴有哮喘且确诊为HDM致敏且无可能干扰计划评估试验的相关伴随疾病的患者符合条件。患者将按1:1的比例随机分为活性AIT组或安慰剂组。实验组将通过皮下途径每月接受12剂AIT，每种变应原的效力为2 RC/ml。预期样本量为来自西班牙16个地点的250名患者。主要疗效指标是鼻炎的综合症状和药物评分（CSMS）。它将由患者自行评估，并通过专门为该研究开发的手机应用程序收集，以提高患者的依从性和数据质量。主要次要指标包括变应性鼻结膜炎症状的扩展CSMS、鼻炎的控制情况、特异性IgE和IgG值、生活质量以及不良反应的数量。还将评估与健康相关的直接和间接成本。最后，将使用几个探索性参数来评估哮喘的严重程度。
这项III期临床试验将有助于为关于变应原疫苗AIT的疗效和安全性的科学证据做出贡献。我们的工作假设是，根据EAACI定义的标准，在伴有或不伴有哮喘的AR患者中，研究产品在提供具有临床意义的改善方面优于安慰剂。该试验还将提供有关使用健康技术评估变应性鼻结膜炎和哮喘的患者报告结局的有价值信息。
EudraCT 2018-003427-11。该记录首次录入的日期：2021-06-14。
