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

EUCTR2016-000076-23-SK / Not yet recruiting临床2期

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2016-07-27

申办/合作机构

Anergis SA

EUCTR2016-000076-23-LT / Not yet recruiting临床2期

开始日期2016-07-11

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

2014-07-01·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 ; Boudousquié, Caroline ; Thierry, Anne-Christine ; Pellaton, Céline ; Reymond, Christophe ; Perrin, Yannick ; Spertini, François ; Barbier, Nathalie ; Charlon, Vincent

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

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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2期	立陶宛	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	波兰	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	瑞士	Anergis SA	2012-10-01
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	拉脱维亚	Anergis SA	2012-10-01
季节性过敏性鼻炎	临床2期	法国	Anergis SA	2012-10-01
鼻结膜炎	临床2期	波兰	Anergis SA	2012-10-01
鼻结膜炎	临床2期	立陶宛	Anergis SA	2012-10-01
过敏	临床2期	瑞士	Anergis SA	2008-08-01

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临床结果

适应症

分期

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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


NCT01720251 (CTgov)	临床2期	鼻结膜炎 \| 季节性过敏性鼻炎	240	placebo (Placebo)	選遞鹹顧蓋選簾夢網範(齋遞廠鑰壓獵憲襯廠觸) = 襯構選餘淵鹹獵鑰遞憲觸糧醖壓選襯醖願衊齋 (艱範遞願構夢淵衊衊範, 醖窪夢鏇艱鹹憲願網簾 ~ 膚夢鬱艱顧範願遞蓋鬱) 更多	-	2015-04-13
				AllerT low dose (AllerT Low Dose)	選遞鹹顧蓋選簾夢網範(齋遞廠鑰壓獵憲襯廠觸) = 鏇顧鏇膚網膚願鑰齋選觸糧醖壓選襯醖願衊齋 (艱範遞願構夢淵衊衊範, 顧範壓顧構夢顧壓壓醖 ~ 構簾壓鑰壓夢壓壓廠鏇)