A Randomized Comparative Clinical Study to Evaluate the Efficacy of Rasona Vati (Allium sativum) and Shuddha Guggulu Vati (Commiphora mukul) in the management of Gridhrasi.

开始日期2023-04-11

申办/合作机构-

NCT05119751 / Completed临床4期IIT

An Investigator-initiated Single Center Randomised Clinical Pilot Study to Compare Tolerability of the Sublingual Versus Vestibular Administration Routes for Birch Pollen, Grass Pollen, Ragweed Pollen, or House Dust Mite Allergy Immunotherapy (AIT)

To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)

开始日期2021-10-25

申办/合作机构

ALK-Abello A/S

NCT04176185 / Terminated临床3期

A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber

This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

开始日期2019-11-04

申办/合作机构

ALK-Abello A/S

100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的临床结果

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100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的转化医学

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100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的专利（医药）

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项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的文献（医药）

2021-12-01·Allergy, Asthma & Clinical Immunology4区 · 医学

Randomized controlled trial of ragweed sublingual immunotherapy tablet in the subpopulation of Canadian children and adolescents with allergic rhinoconjunctivitis

4区 · 医学

ArticleOA

作者: Nolte, Hendrik ; Ellis, Anne K ; Gagnon, Remi ; Bernstein, David I

AbstractBackgroundPost hoc analyses of randomized placebo-controlled trials have demonstrated efficacy and tolerability of the ragweed sublingual immunotherapy (SLIT)-tablet in Canadian adults with ragweed pollen-induced allergic rhinitis/conjunctivitis (AR/C). This post hoc analysis evaluated the efficacy and tolerability of the ragweed SLIT-tablet in the subpopulation of Canadian children and adolescents with AR/C in a previously described randomized, double-blind, placebo-controlled trial.MethodsThe trial (NCT02478398) was conducted in North American and European children/adolescents ages 5–17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥ 80% predicted). Participants were randomized to daily ragweed SLIT-tablet (12 Amb a 1-U) or placebo for up to 28 weeks. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary endpoints were TCS during the entire RPS, and DSS and DMS during peak RPS. Post hoc analyses of the primary and key secondary endpoints were conducted in the subpopulation of Canadian participants.ResultsOf the 1025 randomized participants, 246 (SLIT-tablet, n = 116; placebo, n = 130) were in the Canadian subpopulation. In the total study population, relative TCS (95% CI) improvement with ragweed SLIT-tablet versus placebo was − 38.3% (− 46.0%, − 29.7%; least square [LS] mean difference, − 2.73; P < 0.001) during peak RPS. In the Canadian subpopulation, relative TCS improvements with ragweed SLIT-tablet versus placebo were − 40.8% (− 54.5%, − 20.2%; LS mean difference, − 1.59; P = 0.001) during peak RPS and − 36.6% (− 50.2%, − 16.5%; LS mean difference, − 1.36; P = 0.002) during the entire RPS. DSS and DMS during peak RPS in the Canadian subpopulation improved with SLIT-tablet versus placebo by − 30.6% (− 45.2%, − 7.7%; LS mean difference, − 0.94; P = 0.010) and − 77.2% (− 97.5%, − 44.2%; LS mean difference, − 0.66; P = 0.003), respectively. No events of anaphylaxis, airway compromise, intramuscular epinephrine administration, eosinophilic esophagitis, or severe treatment-related systemic allergic reactions were reported in the overall population or Canadian subpopulation.ConclusionEfficacy and safety of the ragweed SLIT-tablet in Canadian children/adolescents with ragweed pollen-induced AR/C was consistent with the total study population. The ragweed SLIT-tablet resulted in clinically meaningful improvement in symptoms, decreased symptom-relieving medication use, and was well tolerated in Canadian children/adolescents.Trial registration: clinicaltrials.gov, NCT02478398. Registered June 23, 2015, https://clinicaltrials.gov/ct2/show/NCT02478398?term=NCT02478398&draw=2&rank=1

2020-12-01·PharmacoEconomics - Open

Application of a Mapping Function to Estimate Utilities for Ragweed Allergy Immunotherapy Trials

Article

作者: Brandi, Henrik ; Briggs, Andrew ; Dick, Katherine

BACKGROUNDRagweed pollen sensitivity is a common cause of allergic rhinitis (AR) worldwide. AR symptoms include itchy and runny eyes, sneezing, blocked nose, impaired sleep and social and emotional problems, which can have a significant impact on quality of life.OBJECTIVEThe objective of this analysis was to estimate utilities for two pooled standardised quality (SQ) ragweed sublingual immunotherapy (SLIT) tablet trials by applying a previously developed mapping algorithm. This study validated the algorithm and extended its application to ragweed seasonal allergy trials. The mapping algorithm relates disease-specific quality-of-life scores to preference-based utilities that may be used to calculate quality-adjusted life-years (QALYs) in cost-effectiveness studies.METHODSA mapping algorithm based on a grass pollen allergy immunotherapy trial, GT-08 (EudraCT no. 2004-000083-27) was applied to pooled data from two ragweed pollen immunotherapy trials, P05233 (EudraCT 2008-003863-38) and P05234 (EudraCT 2008-003864-20) to generate EuroQoL 5-Dimensions, 3-Levels (EQ-5D-3L) utilities from Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) data.RESULTSThe mean utility difference between the SQ ragweed SLIT tablet and placebo was 0.025 [95% confidence interval (CI) 0.011-0.038]. The SQ ragweed SLIT tablet showed an incremental quality-adjusted life-days (QALDs) benefit of 1.900 (95% CI 0.835-2.916) over 75 days.CONCLUSIONSApplication of a previously developed mapping function allowed for the calculation of QALDs associated with the SQ ragweed SLIT tablet. The results showed a QALD benefit of the SQ ragweed SLIT tablet in P05233 and P05234 trials in the treatment of ragweed pollen-induced AR.

2020-07-01·The Journal of Allergy and Clinical Immunology: In Practice1区 · 医学

Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial

1区 · 医学

Article

作者: Nelson, Harold S ; Ellis, Anne K ; Nolte, Hendrik ; Bernstein, David I ; Kleine-Tebbe, Jörg ; Lu, Susan

BACKGROUNDRagweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.OBJECTIVEThis international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.METHODSChildren (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV₁ ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.RESULTSRelative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.CONCLUSIONSRagweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.

项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的新闻（医药）

2024-02-03

·行舟Drug

推荐阅读 | 浅析按照药品管理的变应原制品注册技术要求

点击上方的行舟Drug ▲ 添加关注摘要变态反应性疾病被世界卫生组织(WHO)认为是当前世界性的重大卫生学问题，当前，变应原制品在国内外临床上已被广泛用于各类变应性疾病的治疗。变应原治疗是目前唯一可调节变应性鼻炎(AR)患者免疫系统的对因治疗措施，然而，高质量的变应原制品关系着制品的有效性。鉴于变应原制品在临床上的重要价值，结合已上市变应原制品和已注册申报变应原制品的研发现状，本文简要介绍变应原制品在我国和美国的注册管理分类，以及我国对该类制品的注册技术要求。变态反应性疾病被世界卫生组织(WHO)认为是当前世界性的重大卫生学问题，主要包括变应性鼻炎(allergic rhinitis，AR)、变应性结膜炎、过敏性哮喘以及接触性皮炎等。而变态反应原(变应原)是指能够引起人类变态反应(过敏反应)性疾病的物质，变应原种类繁多，可来源于微生物、昆虫、动物皮毛、植物及其花粉、食物等。当前，变应原制品是一类从能够引起和(或)激发过敏反应的天然原材料中提取出来的有生物活性的蛋白制品，用于诊断或治疗人类变态反应性疾病，在国内外临床上已被广泛用于各类变应性疾病的治疗。在我国，AR平均患病率逐渐增高，变应原治疗是目前唯一可调节AR患者免疫系统的对因治疗措施[1]。然而，高质量的变应原制品关系着制品的有效性。在WHO及一些发达国家和我国均将这些应用于临床的“变应原”归类于药品中的生物制品进行管理。鉴于变应原制品在临床上的重要价值，结合已上市变应原制品和已注册申报变应原制品的研发现状，本文简要介绍变应原制品在我国和美国的注册管理分类，以及我国对该类制品的注册技术要求，本文仅适用于天然原材料来源的变应原制品，不适用于重组DNA技术来源和化学来源的变应原制品。一我国变应原制品注册管理分类随着科技的发展，目前变应原制品商业化上市申请逐渐增多。变应原制品根据在临床上的用途主要分为治疗用变应原制品、体内诊断用变应原制品和体外诊断用变应原制品，不同类别的变应原制品在药品注册管理上有所不同。1.1 治疗用变应原制品根据我国现行《药品注册管理办法》(2020年版)，治疗用变应原制品在注册分类上属于“生物制品”中治疗用生物制品类别。在我国已上市和已注册申报的治疗用变应原制品均为经过质量控制、标明变应原生物学活性的变应原提取物，包括皮下注射和舌下含服2种给药途径。其中，皮下注射的制品按照无菌产品管理、舌下含服制品不需要按照无菌产品管理。1.2 体内诊断用变应原制品根据我国现行《生物制品注册分类及申报资料要求》(2020年版)中体内诊断试剂按照治疗用生物制品管理，因此，体内诊断用变应原制品在注册分类上属于“生物制品”中治疗用生物制品类别。目前在我国已上市和已注册申报的体内诊断用变应原制品主要包括变应原皮肤点刺产品和皮肤斑贴试验产品。变应原皮肤点刺产品为变应原提取物，其原材料来自天然物质(如尘螨、花粉、动物皮毛等)，诱发过敏反应的物质多为天然物质中所含的特定变应原蛋白，按照无菌产品管理。目前已获批的皮肤斑贴试验产品的原材料多为可诱发接触性皮炎的化学物质，但是在目前的注册管理中皮肤斑贴试验产品也按照“生物制品”中体内诊断试剂管理。1.3 体外诊断用变应原制品根据我国现行《药品注册管理办法》(2020年版)，除了按照药品管理的用于血源筛查的体外诊断试剂、采用放射性核素标记的体外诊断试剂外，其余的体外诊断产品均按照医疗器械管理。根据国家药品监督管理局关于发布《体外诊断试剂分类规则》的公告(2021年第129号)，变应原体外诊断试剂作为第二类体外诊断试剂管理。由于“变应原”种类繁多，目前绝大多数尚未确定其有效成分，难以提取和纯化，不能工业化大批量生产，且临床对每一品种的需求总量不大但又不可或缺，因此在我国还存在一类特殊的变应原制剂，即院内制剂，往往是具有变态反应科的医院制剂室制备、自用，并可通过一定审批程序提供给开展变态反应性疾病诊断和治疗的其他医院使用。鉴于上述实际情况，我国对尚未工业化生产的“变应原”按特殊医院制剂由国家按照生物制品统一管理。除院内制剂外，我国获批的变应原制品均是以终产品的形式上市销售。二美国变应原制品注册管理现状美国FDA的生物制品评估和研究中心(CBER)负责变应原制品注册工作。根据美国FDA对医药产品的分类(网址: https: //www. fda. gov/vaccinesblood-biologics/allergenics#63f54f243265a)，变应原制品被归类为“Vaccines，Blood &Biologics”大类中“Allergenics”类别，主要有变应原提取物制备的舌下片剂(allergen extract sublingual tablets)、注射用变应原提取物(allergen extracts injectable)、变应原斑贴试验产品(allergen patch tests)、抗原皮肤试验产品(antigen skin tests)、口服免疫治疗产品(oral im-munotherapy)。2.1 注射用变应原提取物注射用变应原提取物是从可诱发过敏反应的天然物质(如霉菌、花粉、昆虫、动物皮毛等)中分离出来，可被用于体内诊断和脱敏治疗，其中针对食物过敏的可注射用变应原提取物仅用于诊断用途。皮下注射给药途径的治疗用变应原药物、变应原皮肤点刺产品均属于美国FDA注册管理中的可注射用变应原提取物。注射用变应原提取物分为标准化(standard-ized)和非标准化(non-standardized) 2类。标准化制品涵盖了动物皮毛、尘螨、花粉、昆虫毒素/毒素蛋白等19个变应原种类，采用CBER管理的美国参考标准品来确定每批产品活性。非标准化产品是指没有进行活性定量的变应原提取物。2.2 变应原提取物舌下片剂变应原提取物舌下片剂是以可诱发过敏反应的天然物质为原料制备而成的通过舌下给药途径进行脱敏治疗的固体制剂，目前主要有4类产品，分别为梯牧草花粉舌下片剂(GRASTEK)，由黄花茅、鸭茅、多年生黑麦、梯牧草和早熟禾5类花粉变应原提取物混合制备的舌下片剂(ORALAIR)，由屋尘螨和粉尘螨变应原提取物制备而成的尘螨舌下片剂(ODACTRA)，由短豚草花粉变应原提取物制备的舌下片剂(RAGWITEK)。此类产品多是2017年后在美国批准上市，仅具有特异性脱敏治疗用途，用于治疗相关变应原引起的AR，并发或不并发变应性结膜炎。这类产品在美国的获批上市意味着美国FDA对变应原免疫治疗终产品开始接纳。美国FDA分类中未见舌下含服的变应原提取物液体制剂。2.3 变应原斑贴试验产品变应原斑贴试验产品是被用于皮肤表面的诊断用产品，使用已知可引起接触性皮炎的天然物质或化学物质(如镍、橡胶、芳香混合物等等)制备而成。专业医护人员用斑贴试验来识别接触性皮炎的发病原因。2.4 抗原皮肤试验产品美国FDA已批准的抗原皮肤试验产品是指用于皮肤试验辅助诊断能引起变态反应的体内诊断类抗原，不仅包括我们通常理解的变应原类产品。该类产品可包括引起过敏反应的变应原类抗原，也可包括用于诊断特定病原体感染的诊断抗原，如结核菌素纯化蛋白衍生物(PPD)。三我国按照药品管理变应原制品的技术要求3.1 初始原材料由于天然原材料来源的变应原制品固有的可变性，该类制品在批间一致性方面具有特殊的挑战性，因此应加强该类制品初始原材料控制，申报中应详细说明初始原材料的收集和(或)培养方法、处理方法和储存要求，应纳入每批次原始材料的检测报告和结果，以保证原材料的质量可控性。常见的初始原材料相关技术要求如下，其余种类的初始原材料可参照执行: 花粉类应明确收获的生态环境和收集方法; 真菌类应明确相关谱系、培养基组成和培养方法; 螨虫类原材料的质量控制可见《中华人民共和国药典》2020年版三部的螨变应原制品总论，应明确选用螨虫的谱系、饲养物组成和培养方法等。初始原材料的质控方面，应包括鉴别、纯度、效价分析等项目并设定标准限度，以保证初始原材料质量属性的批件一致性。3.2 生产工艺生产工艺应经过验证，明确关键工艺步骤、参数和范围，以及过程控制的关键质量属性。应按照《药品生产质量管理规范》相关要求和批准的生产工艺进行生产，以保证制品的批间一致性。生产过程控制方面，应具有生产过程流程图，同时详细说明生产步骤的相关参数，明确关键生产工艺步骤、参数和具体的控制范围。制品的开发历史中说明生产工艺具体的纯化和分离原理。生产工艺描述部分，提取工艺中应纳入起始物料、起始物料与缓冲液的比例、温度、时间、贮存条件(必要时)等。纯化工艺中应纳入温度、时间、过滤装置和孔径、储存条件(必要时)。无菌过滤工艺中应纳入温度、时间、过滤装置和孔径等。制剂中辅料应符合《中华人民共和国药典》2020年版相关要求，尽可能避免含有对人有免疫原性或过敏性的成分。3.3 质量标准和标准品变应原制品本身具有质量属性的复杂性，存贮和运输条件不当均可导致制品质量的改变，造成安全隐患，例如，有文献报告，屋尘螨变应原制剂的储存过程的低温冻结引起的外观异常导致制品生物活性的降低[9]，因此其质量管理体系是确保制品的安全性和有效性的关键，应贯穿制品生产的整个生命周期。研发者应对变应原制品的原液、半成品和成品进行质量检测以保证批间的一致性，同时应明确质控的所有检测方法和标准，以及方法建立的依据。质控的项目一般包括总蛋白质含量、蛋白质电泳图谱、变应原反应图谱、主要变应原含量、总变应原活性等。其他质控项目中，注射剂和体内诊断制剂应进行无菌检查，口服制剂应进行微生物限度检查。若添加其他组分(如抑菌剂、甘油、佐剂等)，应采用适宜的方法测定，明确标准范围。质控项目和标准应符合《中华人民共和国药典》2020年版、ICH Q6B等相关要求。变应原制品基本都是天然粗抗原提取物，成分比较复杂，参比品对于变应原制品质量的质量评价尤为重要，企业内部参考品应来源于代表性工艺制备的样品，以用于变应原制品的鉴别和效价测定。应明确内部参考品的结构表征，包括蛋白质含量、蛋白质图谱、主要变应原组分的含量等，方法包括电泳法、色谱技术和质谱等，以及批次间效价的桥接。四展望我国过敏患者日益增多与相应治疗产品严重缺乏的矛盾日益突出。我国脱敏治疗产品极度缺乏的主要原因在于我国对变应原制品的质控技术体系比较薄弱，缺乏国家标准、标准品以及标准化的检定方法。欧洲和美国等国家对于变应原制品的质量控制标准也存在差异。虽然欧洲变应原制品的品种丰富，但质量标准也不完善，且缺乏明确疗效指标，临床试验开展难度大，导致进口我国存在困难。为推动我国脱敏治疗产业的发展，首先需要完善变应原制品质量控制体系，为制品发展提供行业指导。《中华人民共和国药典》2020年版新增了“螨变应原制品总论”，规定了螨变应原制品的生产工艺基本要求和关键质控要求，重点描述了对螨虫的虫种管理要求，规定了包括原材料、原液、半成品、成品的检查项目和通用的标准，可供该类制品参考。其次也需要探索质量评价关键技术，一方面我们需要建立通用效力评价方法及效力评价参考品，克服当前各企业变应原制品效力单位多样化，溯源性差等不足，另一方面也需要建立脱敏制剂疗效评价体系，筛选客观的疗效考核指标，解决临床试验和上市效果评价等关键问题，为制品申报提供技术支撑。同时，建议采用新的方法来进行该类产品的质量控制。变应原通用参考品的建立可提高制品的批间一致性和同类制品厂家间的可比性[10]。参考文献[1] 储俊才，程雷，变应性鼻炎变应原免疫治疗新指南[.中国中西医结合耳泉明喉科杂志，2018，26(3):161-162.[2] 国家药品监督管理局药品审评中心，变态反应原(变应原)制品质量控制技术指导原则(].2003.5][3] 张影，杨蕾，赵爱华，螨变应原制品总论增订概况 [J].中国药品标准，2022，23(3):258-262.[4] 张影，2020 版《中华人民共和国药典》螨变应原制品总论解读Ш]，中华临床免疫和变态反应杂志，2021，15(1):106-107.[5] GOODMAN RE,CHAPMAN MD, SLATER JE. The allergen :sourees, exlmels, anl molecules for diagnosis of alergie diease.JAllergy clin lmmuol Praet,2020,8(8):2506-2514.[6] RABIN RL, BRIDGEWATER J, SLATER JE, Regulaion of al-lergen immunohempy produets in Europe and the United Slales.JAllegyr Chn /mmenal, 2019,144(4):1140.[7] BONERTZ A, ROBERTS G, SLATER JE,et al. Allergen man-ulacturing anl quality aspeds hr allergen imnathempy in Europe and the United Siates: an analysis fm the EAACl AfrGuidelines Pmjeet [. Allagy,2018,73(4):816-826.[8] 石继春，王春娥，王珊珊，等.屋尘螨变应原制剂质量标准的研究町，中国药事，2014，28(6):622-625.[9] 张影，鲁旭，梁吴字，等.屋尘螨变应原制剂外观异常对其质量的影响山，中国生物制品学杂志，2020，33(3):280-285.[10] 张影，鲁旭，王斌，等，螨变应原制品的质量控制及标准化研究进展团，中国生物制品学杂志，2019(5):594-599.文章信息源于公众号注册圈，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug每日更新欢迎订阅+医药大数据|行业动态|政策解读

基因疗法核酸药物上市批准

2024-01-18

·GlobeNewswire-Health Care

ALK completes first part of phase 1 trial with peanut SLIT-tablet

The trial now progresses into its second part, expected to complete later in 2024. ALK to submit a protocol amendment for Phase 1-2 efficacy trial extension. ALK (ALKB:DC / OMX: ALK B / AKBLF) announced today that it has completed the first part of its phase 1 clinical trial (named ‘ALLIANCE’) for its investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy. The first part of the trial investigated the safety and tolerability of 14 days treatment with the peanut tablet at different starting doses. For all dose levels, the peanut tablet was shown to be safe and tolerable and with a safety and tolerability profile in accordance with that of the approved SLIT-tablets (ACARIZAX/ODACTRA®, GRAZAX®/GRASTEK®, RAGWIZAX®/RAGWITEK®, ITULAZAX®/ITULATEK®). No serious adverse events and no cases of treatment emergent anaphylaxis were reported. Based on results from part 1, the starting dose for the second part of the study has been selected. This part of the study will evaluate the safety and tolerability of up-dosing to the highest tolerable maintenance dose. The second part will be initiated imminently and is scheduled to complete later in 2024. Furthermore, ALK has decided to amend the ALLIANCE study protocol to include a third part involving approximately 100 additional patients. This part will evaluate safety and efficacy of the peanut SLIT-tablet as assessed by an oral food challenge following a period of maintenance treatment. The implementation of the third part is contingent upon a successful outcome of the second part. The revised protocol is expected soon to be submitted to the relevant authorities. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “We are pleased to report positive progress in our ALLIANCE trial, addressing potentially life-threatening peanut allergy. Encouraged by the initial results for the peanut tablet, we have made a provisional decision to extend the trial into a seamless Phase 1-2 design allowing us to explore the efficacy of the tablet as well. Leveraging our profound R&D expertise, we remain committed to developing valuable new treatment options for people with allergy”. In the USA, peanut allergy affects up to 1.5 million children and adolescents aged 4-17, while in Europe, around 1 million children and adolescents are affected by this potentially life-threatening condition. The disease often presents in early childhood and can last a lifetime. For some of these patients, allergy immunotherapy may become a relevant treatment option with the potential to improve quality of life, both for them and their families. This announcement is not expected to materially change the R&D cost outlook for 2024-25. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation. About the ALLIANCE trialInitiated in 2022, the ALLIANCE trial was designed to assess the tolerability and safety of an up-dosing regimen with a once-daily peanut SLIT-tablet in adults, adolescents, and children. The trial is a phase I, open-label, dose-escalation, multi-site trial conducted in North America, with approximately 100 participants with peanut allergy confirmed by screening via a double-blind, placebo-controlled food challenge. The first part of the trial aimed at determining the starting dose of the up-dosing regimen and the second part to assess safety and tolerability of the up-dosing regimen as well as gather early data on its biological action. The third part intends to investigate safety and efficacy of selected doses of the peanut SLIT-tablet compared with placebo. The trial marked the formal start of ALK’s clinical development of a novel food allergy treatment which uses the same technology as ALK’s SLIT tablets for respiratory allergies. About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment FM_01_2024UK_18012024

免疫疗法临床1期

2021-04-19

·BioSpace

U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis About ALK ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and doctors. Headquartered in Hørsholm, Denmark, the company employs around 2,500 people worldwide and is listed on Nasdaq Copenhagen. To learn more about ALK and allergies, visit . For further information, please contact: ALK: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Stuart Loesch, tel. +1 908 842 8363, mobile +1 267 753 5838 View original content to download multimedia: SOURCE ALK, INC.

免疫疗法

100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V01AA02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
变应性结膜炎	俄罗斯	ALK-Abello A/S	2019-12-31
结膜炎	美国	ALK-Abello A/S	2014-04-17
结膜炎	美国	Merck Sharp & Dohme Corp.	2014-04-17
过敏性鼻炎	美国	Merck Sharp & Dohme Corp.	2014-04-17
过敏性鼻炎	美国	ALK-Abello A/S	2014-04-17
季节性过敏性鼻炎	法国	-	2012-01-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
季节性过敏性鼻炎	临床1期	丹麦	ALK-Abello A/S	2004-10-01
过敏	临床前	丹麦	ALK-Abello A/S	2004-10-01
鼻结膜炎	临床前	丹麦	ALK-Abello A/S	2004-10-01
哮喘	药物发现	-	Merck Sharp & Dohme Corp.	2015-07-20
豚草过敏	药物发现	-	ALK-Abello A/S	2011-11-01
过敏性鼻炎伴哮喘	药物发现	-	ALK-Abello A/S	2009-09-01
过敏性鼻结膜炎	药物发现	-	ALK-Abello A/S	2009-09-01
结膜炎	药物发现	-	Lundbeckfonden	2009-09-01
过敏性鼻炎	药物发现	-	Lundbeckfonden	2009-09-01
过敏性鼻炎	药物发现	-	ALK-Abello A/S	2009-09-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02478398 (CTgov)	临床3期	季节性过敏性鼻炎 \| 哮喘 \| 过敏性鼻结膜炎	1,025	Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine+Short ragweed pollen allergen extract (Short Ragweed Pollen Allergen Extract)	簾積繭獵獵夢鹽壓淵獵(醖鹹廠積醖獵壓醖艱積) = 夢築淵壓廠齋衊顧淵夢壓鏇鏇齋醖願壓醖膚窪 (製觸積鏇鹽餘鏇鹹壓蓋, 觸艱構鑰衊觸製製夢糧 ~ 構淵構壓憲網範衊淵衊) 更多	-	2019-07-09
				Placebo+Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine (Placebo)	簾積繭獵獵夢鹽壓淵獵(醖鹹廠積醖獵壓醖艱積) = 糧襯構壓窪膚鹽簾衊憲壓鏇鏇齋醖願壓醖膚窪 (製觸積鏇鹽餘鏇鹹壓蓋, 廠鏇獵淵鬱鹹夢構鹽鏇 ~ 餘製觸選選積膚鬱糧鹽) 更多
NCT02256553 (P08607, CTgov)	临床4期	季节性过敏性鼻炎 \| 结膜炎	102	MK-7243+MK-3641 (MK-3641+MK-7243)	鏇網廠餘衊鑰獵廠遞鏇(鹽蓋鏇鬱鹽廠衊窪餘壓) = 廠網獵壓餘夢繭壓蓋糧醖壓淵壓觸築夢願觸鹹 (醖簾餘網選餘構窪積糧, 遞壓願製鬱積繭膚壓廠 ~ 繭廠憲夢窪範襯齋築獵) 更多	-	2016-01-18
				MK-7243 (Period I: MK-7243)	簾淵鹹窪齋窪製繭淵範(遞願簾選繭觸衊齋簾憲) = 製願蓋夢齋廠壓鬱壓廠壓齋窪遞選齋顧鏇製觸 (積鬱夢獵鏇窪獵製構構, 繭醖憲遞窪網網齋鹽衊 ~ 鏇蓋鑰範範範鏇鬱願遞) 更多
NCT00783198 (P05233, CTgov)	临床2/3期	过敏性鼻结膜炎 \| 过敏性鼻炎伴哮喘	565	SCH 39641 6 Amb a 1-U (SCH 39641 6 Amb a 1-U)	遞艱鹽簾繭夢淵顧艱夢(艱蓋積製範願齋齋夢觸) = 繭淵範壓鹽衊鬱鹹顧構觸齋顧齋顧醖醖襯糧鹽 (襯糧鑰淵鹽築醖構鹹鏇, 築選夢願膚鹽選糧壓餘 ~ 壓繭鑰遞鑰鏇鹽艱膚蓋) 更多	-	2014-07-14
				SCH 39641 12 Amb a 1-U (SCH 39641 12 Amb a 1-U)	遞艱鹽簾繭夢淵顧艱夢(艱蓋積製範願齋齋夢觸) = 鑰獵鏇壓鬱糧遞壓鹹衊觸齋顧齋顧醖醖襯糧鹽 (襯糧鑰淵鹽築醖構鹹鏇, 壓廠蓋鬱膚鹽淵廠膚窪 ~ 鬱築淵遞鑰鹹積憲襯築) 更多
NCT01469182 (P05751, CTgov)	临床3期	豚草过敏 \| 过敏	914	SCH 39641 (SCH 39641 12 Amb a 1-U)	積壓遞艱壓糧蓋壓艱範(衊衊襯鑰繭艱鑰鏇獵鹹) = 衊襯鏇醖製齋範獵衊鹹簾觸壓築壓衊鑰壓膚積 (糧廠夢簾醖襯餘築窪繭, 醖願夢艱艱鏇憲鑰製鏇 ~ 築遞積醖壓製觸遞簾壓) 更多	-	2014-06-05
				Placebo for SCH 39641 (Placebo)	積壓遞艱壓糧蓋壓艱範(衊衊襯鑰繭艱鑰鏇獵鹹) = 網憲製範獵窪糧範簾鬱簾觸壓築壓衊鑰壓膚積 (糧廠夢簾醖襯餘築窪繭, 廠淵選製鏇願糧醖憲壓 ~ 製製鏇餘廠鏇壓鑰醖顧) 更多
NCT00978029 (P06081, CTgov)	临床2期	鼻结膜炎 \| 过敏性鼻结膜炎 \| 过敏	203	Placebo (Placebo)	鬱觸糧獵壓淵選遞顧範(觸製鑰艱築艱鏇壓顧蓋) = 製選醖廠簾積壓鹽獵膚窪齋鹹糧鹽憲壓築繭夢 (觸膚製繭醖齋窪醖鹽範, 齋鹽簾積廠壓鬱齋遞夢 ~ 顧糧蓋鹽遞積壓醖鏇願) 更多	-	2014-05-23
				SCH 39641 (SCH 39641 6 Amb a 1-U)	鬱觸糧獵壓淵選遞顧範(觸製鑰艱築艱鏇壓顧蓋) = 簾鑰繭選構廠廠積齋餘窪齋鹹糧鹽憲壓築繭夢 (觸膚製繭醖齋窪醖鹽範, 窪鏇鑰艱鬱鑰襯糧簾積 ~ 鹽蓋窪廠淵願觸獵範遞) 更多