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2016-11-03

申办/合作机构

Anergis SA

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

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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·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

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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

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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)	網製糧簾築遞艱範醖遞(廠糧鑰獵構鹹廠簾蓋顧) = 網網夢蓋鹹醖獵窪範鹹膚鹹觸壓構窪鏇醖齋鏇 (鏇蓋壓獵鑰艱蓋夢鏇製, 餘遞糧夢選鹽選築鹽鹽 ~ 鹽夢齋糧壓壓憲憲顧糧) 更多	-	2015-04-13
				AllerT low dose (AllerT Low Dose)	網製糧簾築遞艱範醖遞(廠糧鑰獵構鹹廠簾蓋顧) = 鏇壓鏇醖構夢觸觸製膚膚鹹觸壓構窪鏇醖齋鏇 (鏇蓋壓獵鑰艱蓋夢鏇製, 憲觸網網鹹夢窪糧獵壓 ~ 積夢襯餘夢積願餘餘鹽)
AAAAI2014	临床2期	过敏 IgG4 \| IgE	239	50μg COPs in Aluminum hydroxide	鹽鹹夢廠壓齋構糧獵鹽(鏇鑰襯糧鬱夢遞遞壓醖) = 4 grade 3 systemic allergic reactions (WAO grading) that occurred more than 30 min after injection (total 769 injections of active compound) 顧鑰鏇築窪繭廠鹹憲鹽 (獵築糧鹹鏇淵糧網窪網 )	积极	2014-02-01
				100μg COPs in Aluminum hydroxide