Birch pollen allergy vaccine(Anergis)(Birch pollen allergy vaccine(Anergis))

概要

基本信息

药物类型

变应原提取物

别名

AllerT、AllerT-Birch

靶点-

作用方式

调节剂

作用机制

免疫调节剂

治疗领域

免疫系统疾病感染眼部疾病+ [2]

在研适应症-

非在研适应症

过敏性鼻结膜炎过敏反应过敏性鼻炎+ [2]

原研机构

University of Lausanne

在研机构-

非在研机构

Anergis SA

权益机构

Anergis SA

Mymetics Corp.

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 Birch pollen allergy vaccine(Anergis) 相关的临床试验

NCT02943720

/ Completed临床2期

A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis

A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis

开始日期2016-09-01

申办/合作机构

Anergis SA

NCT02271009

/ Completed临床2期

A Double-Blind, Placebo-Controlled, Randomized Trial to Compare the Efficacy and Tolerability of Three Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in Environmental Exposure Chamber

The purpose of this study is to find the optimal dose of AllerT that should be used to treat moderate to severe allergies due to birch tree pollen.
There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at different doses and 1 treatment group will receive placebo.
This study will also assess the effectiveness and safety of AllerT compared to placebo in relieving allergy symptoms.

开始日期2014-10-01

申办/合作机构

Anergis SA

[+1]

NCT01720251

/ Completed临床2期

Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen

The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

开始日期2012-10-01

申办/合作机构

Anergis SA

100 项与 Birch pollen allergy vaccine(Anergis) 相关的临床结果

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100 项与 Birch pollen allergy vaccine(Anergis) 相关的转化医学

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100 项与 Birch pollen allergy vaccine(Anergis) 相关的专利（医药）

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1

项与 Birch pollen allergy vaccine(Anergis) 相关的文献（医药）

2014-07-01·The Journal of allergy and clinical immunology1区 · 医学

Safety and immunogenicity of immunotherapy with Bet v 1–derived contiguous overlapping peptides

1区 · 医学

Letter

作者: Audran, Régine ; Thierry, Anne-Christine ; Barbier, Nathalie ; Reymond, Christophe ; Spertini, François ; Charlon, Vincent ; Boudousquié, Caroline ; Pellaton, Céline ; Perrin, Yannick

This article presents the safety and immunogenicity of immunotherapy with Bet v 1-derived contiguous overlapping peptides.Clin. trial showed that 5 injections of AllerT administered over 2 mo elicit a strong immune response in the range of that observed after 50 injections and 3 years with other allergens and led to long-term immunol. memory were presented.Changes from baseline in Bet v 1-specific IgG4 and IgE levels were determined, and the ratios of normalized anti-Bet v 1 IgG4 and anti-Bet v 1 IgE over baseline were shown graphically.On an exploratory basis, P values for the median fold difference in IgG4 and IgE levels between AllerT- and placebo-treated patients were determined by using the nonparametric, nonpaired Mann-Whitney test.

100 项与 Birch pollen allergy vaccine(Anergis) 相关的药物交易

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研发状态

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
过敏性鼻结膜炎	临床2期	加拿大	Anergis SA	2014-10-01
过敏性鼻炎	临床2期	加拿大	Anergis SA	2014-10-01
季节性过敏性鼻炎	临床2期	丹麦	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	法国	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	拉脱维亚	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	立陶宛	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	波兰	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	瑞典	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	瑞士	Anergis SA	2012-10-01
鼻结膜炎	临床2期	丹麦	Anergis SA	2012-10-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01720251 (CTgov)	临床2期	鼻结膜炎 \| 季节性过敏性鼻炎	240	placebo (Placebo)	夢選網淵襯簾鏇糧獵選(淵網廠艱鹹壓衊鹽遞鹽) = 夢遞膚膚艱遞製膚膚築範簾願齋願齋醖蓋獵網 (鬱壓鹽簾簾襯夢網憲製, 0.603) 更多	-	2015-04-13
				AllerT low dose (AllerT Low Dose)	夢選網淵襯簾鏇糧獵選(淵網廠艱鹹壓衊鹽遞鹽) = 鹹衊製齋遞製餘製構鏇範簾願齋願齋醖蓋獵網 (鬱壓鹽簾簾襯夢網憲製, 0.530)
AAAAI2014	临床2期	过敏反应 IgG4 \| IgE	239	50μg COPs in Aluminum hydroxide	鬱膚鏇獵簾廠糧顧糧齋(壓憲窪艱餘襯餘顧窪網) = 4 grade 3 systemic allergic reactions (WAO grading) that occurred more than 30 min after injection (total 769 injections of active compound) 網廠觸糧鹹遞構積夢壓 (餘構選膚鬱網築鏇顧襯 )	积极	2014-02-01
				100μg COPs in Aluminum hydroxide