Zielen Stefan, Bernstein Jonathan A, Sturm Gunter J, Jutel Marek, Pfaar Oliver, Shamji Mohamed H, Mösges Ralph, Berger Markus, Berger Uwe E, DuBuske Lawrence, Layhadi Janice A, Klimek Ludger, Ollert Markus, Skinner Murray A, Kramer Matthias F, de Kam Pieter-Jan
Department of Pediatrics, University Hospital, Goethe University, Frankfurt, Germany.
Respiratory Research Center Medaimun GmbH, Frankfurt, Germany.
Allergy. 2025 Jul;80(7):1982-1994. doi: 10.1111/all.16491. Epub 2025 Feb 4.
PQ Grass 27600 SU (PQ Grass) cumulative dose is a pre-seasonal, six-injection, aluminium-free, modified subcutaneous immunotherapy product under development for the treatment of allergic rhinitis (AR). A pivotal Phase III randomised double-blind, placebo-controlled clinical trial was performed to evaluate the efficacy and safety of PQ Grass in subjects with seasonal AR.
An adaptive group sequential trial PQGrass306 (G306) with one pre-defined interim analysis was designed, using 2 parallel groups applying a 1:1 active versus placebo randomisation of patients aged 18-65. The primary efficacy endpoint was the EAACI (European Academy of Allergy and Clinical Immunology) Combined Symptom and Medication Score (EAACI-CSMS) averaged over the peak grass pollen season (GPS).
858 subjects were screened and 555 subjects were randomised. Based on the results of the pre-defined interim analysis, the trial was stopped for success showing superiority in favour of PQ Grass. The primary endpoint EAACI-CSMS (peak GPS) demonstrated a highly significant and clinically meaningful point difference of PQ Grass over placebo of -0.27 points (95% CI: -0.42 to -0.12), corresponding to a relative difference of -20.3% (p = 0.0005). Highly consistent and beneficial results were obtained for PQ Grass for all key secondary endpoints. Significant induction of blocking IgG4 and IgA antibody subclasses occurred. PQ Grass was well tolerated, and no unexpected safety signals occurred.
This pivotal Phase III trial demonstrated a significant and clinically meaningful effect on the primary endpoint as well as highly consistent secondary endpoint results and a supportive safety profile.
PQ草27600标准化单位（PQ草）累积剂量是一种正在研发的用于治疗变应性鼻炎（AR）的季节性前、六次注射、无铝、改良皮下免疫疗法产品。进行了一项关键的III期随机双盲、安慰剂对照临床试验，以评估PQ草在季节性AR患者中的疗效和安全性。
设计了一项具有一次预定义中期分析的适应性成组序贯试验PQGrass306（G306），采用2个平行组，对18至65岁的患者进行1:1活性药物与安慰剂随机分组。主要疗效终点是在草花粉高峰季节（GPS）期间平均的欧洲变态反应和临床免疫学会（EAACI）综合症状和药物评分（EAACI-CSMS）。
筛选了858名受试者，555名受试者被随机分组。根据预定义中期分析的结果，试验因成功而停止，显示PQ草具有优势。主要终点EAACI-CSMS（GPS高峰）显示，PQ草比安慰剂有高度显著且具有临床意义的点差异，为-0.27分（95%CI：-0.42至-0.12），相对差异为-20.3%（p = 0.0005）。PQ草在所有关键次要终点上均获得了高度一致且有益的结果。诱导产生了显著的阻断性IgG4和IgA抗体亚类。PQ草耐受性良好，未出现意外的安全信号。
这项关键的III期试验证明了对主要终点有显著且具有临床意义的效果，以及高度一致的次要终点结果和支持性的安全性概况。
