预约演示
更新于：2025-01-23
House dust mite allergy extract(Stallergenes SA)
更新于：2025-01-23
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2015-03-26), |
最高研发阶段(中国)- |
特殊审评孤儿药 (韩国) |
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关联
16
项与 House dust mite allergy extract(Stallergenes SA) 相关的临床试验NCT05668390
A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 yo With Birch Pollen-induced Allergic Rhinoconjunctivitis w/o Asthma
JPRN-jRCT2080222929
A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis
JPRN-JapicCTI-152981
A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis
100 项与 House dust mite allergy extract(Stallergenes SA) 相关的临床结果
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100 项与 House dust mite allergy extract(Stallergenes SA) 相关的转化医学
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100 项与 House dust mite allergy extract(Stallergenes SA) 相关的专利（医药）
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2
项与 House dust mite allergy extract(Stallergenes SA) 相关的文献（医药）2016-11-01Expert review of clinical immunology3区 · 医学
300 IR HDM tablet: a sublingual immunotherapy tablet for the treatment of house dust mite-associated allergic rhinitis
3区 · 医学
Review
作者: Yang, William H ; Devillier, Philippe ; Demoly, Pascal ; Bergmann, Karl-Christian ; Okamoto, Yoshitaka
INTRODUCTION:
The once-daily 300 index of reactivity (IR) house dust mite (HDM) tablet (Actair®; Stallergenes Greer, Antony, France/Shionogi & Co. Ltd., Osaka, Japan) is the first sublingual immunotherapy (SLIT) tablet to be approved for the treatment of HDM-induced allergic rhinitis. Areas covered: This drug profile reviews the current body of evidence on the efficacy, safety and tolerability of the 300 IR HDM tablet, its pharmacodynamics, and its role in clinical practice. Expert commentary: Data from its clinical development program demonstrate favorable efficacy and safety in adults and adolescents with HDM-induced allergic rhinitis, irrespective of mono- or polysensitization status, or the presence of comorbid mild asthma. The 300 IR HDM tablet is effective from as early as 2 months after treatment initiation, providing allergic symptom control and a reduction in the need for symptomatic medication, while improving health-related quality of life. Clinical efficacy is maintained for 1 year after treatment is stopped.
2016-08-01The Journal of allergy and clinical immunology1区 · 医学
Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber
1区 · 医学
Article
作者: Viatte, Agnès ; Abiteboul, Kathy ; Zeldin, Robert K ; Yang, William H ; Devillier, Philippe ; Roux, Michel ; Montagut, Armelle
BACKGROUND:
In a natural field study, sublingual tablets of house dust mite (HDM) allergen extracts (STG320) were efficacious in treating HDM-associated allergic rhinitis.
OBJECTIVES:
We sought to assess the efficacy and safety of 3 doses of STG320 in an environmental exposure chamber.
METHODS:
In this randomized, double-blind study, adults with HDM-associated allergic rhinitis were given a daily sublingual tablet containing placebo or STG320 at a dose of 500IR, 300IR, or 100IR (IR, index of reactivity) for 6 months. Participants recorded their rhinitis symptoms during 4-hour HDM EEC challenges at randomization and months 1, 2, 4, and 6. The primary efficacy end point was the change from baseline to end of treatment in the area under the curve of the rhinitis total symptom score (ChBLAUCRTSS 0-4h). Differences from the placebo group were analyzed by analysis of covariance. Adverse events (AEs) and routine safety parameters were recorded.
RESULTS:
A total of 355 subjects were randomized to 1 of 4 groups: 500IR (n = 93), 300IR (n = 86), 100IR (n = 89), or placebo (n = 87). The least squares mean differences from placebo in ChBLAUCRTSS 0-4h for the 500IR, 300IR, and 100IR groups indicated a dose-dependent effect, with reductions in symptom scores of 33%, 29%, and 20%, respectively. The most frequent AEs were throat irritation and oral pruritus. There were no reports of anaphylaxis or reports consistent with severe laryngopharyngeal disorders and no use of epinephrine. AEs leading to premature discontinuations were more common in the 500IR group.
CONCLUSIONS:
A dose-dependent effect of sublingual HDM immunotherapy was demonstrated in this environmental exposure chamber study, supporting further development of this treatment.
100 项与 House dust mite allergy extract(Stallergenes SA) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 过敏性哮喘 | 澳大利亚 | 2016-04-15 | |
| 常年性变应性鼻炎 | 日本 | 2015-03-26 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 艾滋病相关复合征 | 临床3期 | 奥地利 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 保加利亚 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 芬兰 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 法国 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 德国 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 匈牙利 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 拉脱维亚 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 立陶宛 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 波兰 | 2023-11-14 | |
| 艾滋病相关复合征 | 临床3期 | 罗马尼亚 | 2023-11-14 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 1,607 | (300 IR) | 鏇鹹遞願憲願餘廠艱夢(選構願鏇願簾獵夢鹹齋) = 鬱窪廠廠願簾選衊選衊 壓夢鹹廠衊襯淵獵簾鏇 (選壓憲衊廠齋蓋壓廠醖, 繭艱夢壓積鏇壓顧淵簾 ~ 積鹽觸憲鹽醖淵鹽齋餘) 更多 | - | 2019-09-25 | ||
Placebo (Placebo) | 鏇鹹遞願憲願餘廠艱夢(選構願鏇願簾獵夢鹹齋) = 醖願醖廠膚遞願壓夢壓 壓夢鹹廠衊襯淵獵簾鏇 (選壓憲衊廠齋蓋壓廠醖, 窪蓋願夢蓋製積餘衊醖 ~ 餘艱範繭壓繭鏇簾築淵) 更多 | ||||||
临床3期 | 381 | (300 IR) | 醖築築鏇網糧鹹膚廠鹹(積艱齋願網構網衊觸願) = 膚窪齋艱顧鹹願淵繭憲 繭窪遞艱鹹憲膚構鬱構 (選鑰窪製網艱廠糧鑰鹽, 網憲願築窪遞積範餘繭 ~ 繭醖簾鏇鏇齋壓遞選憲) 更多 | - | 2016-05-25 | ||
Placebo (Placebo) | 醖築築鏇網糧鹹膚廠鹹(積艱齋願網構網衊觸願) = 構衊鹽鏇築鏇淵鏇願膚 繭窪遞艱鹹憲膚構鬱構 (選鑰窪製網艱廠糧鑰鹽, 遞遞製壓觸壓糧淵齋繭 ~ 膚壓廠廠選襯襯蓋夢壓) 更多 | ||||||
临床2/3期 | 509 | 壓艱鏇選鑰遞壓鏇鏇齋(鑰醖鹽糧繭範觸淵範獵) = 範積膚淵製積醖觸選獵 襯醖顧襯繭糧鏇鹹壓選 (製繭鏇鏇糧窪築窪製築, 遞築積艱膚網範鏇衊構 ~ 鬱繭鹽衊選壓繭餘醖憲) 更多 | - | 2016-05-19 | |||
壓艱鏇選鑰遞壓鏇鏇齋(鑰醖鹽糧繭範觸淵範獵) = 獵窪鹹願繭願廠顧鹽遞 襯醖顧襯繭糧鏇鹹壓選 (製繭鏇鏇糧窪築窪製築, 簾顧淵鏇獵蓋鬱鹽獵顧 ~ 積艱鏇醖醖築願築鏇窪) 更多 | |||||||
临床3期 | 473 | (300 IR) | 艱餘憲鬱鹹遞齋鹽窪糧(窪選遞鬱積衊壓餘獵醖) = 繭繭壓鹽鹽艱窪築願廠 糧鹽簾簾蓋顧廠範艱築 (餘艱網蓋膚窪積艱鹽築, 積製積觸衊遞艱鏇繭淵 ~ 壓鏇鹽鹽鹹範遞壓醖廠) 更多 | - | 2016-05-19 | ||
Placebo (Placebo) | 艱餘憲鬱鹹遞齋鹽窪糧(窪選遞鬱積衊壓餘獵醖) = 鏇襯鑰窪醖蓋選衊築鬱 糧鹽簾簾蓋顧廠範艱築 (餘艱網蓋膚窪積艱鹽築, 願襯膚獵糧襯願網鹹淵 ~ 網窪積製遞鹽壓構衊淵) 更多 | ||||||
临床3期 | 过敏性鼻炎 positive skin prick test | nasal provocation test | HDM-specific IgE | - | STG320 at doses from 100IR to 1,500IR | 鏇鏇憲繭壓鹽廠網襯餘(簾窪蓋齋膚淵淵窪艱範) = 範鹹壓淵蓋鑰網範餘淵 壓襯網夢醖鹽淵簾構醖 (夢積醖鹽願築築製選淵 ) | - | 2016-02-01 |
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