预约演示
更新于：2025-02-11
House dust mite allergy extract(Stallergenes SA)
更新于：2025-02-11
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
14
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-JapicCTI-152981
A Phase 3 Study of S-524101 in the Pediatric Patients with Perennial Allergic Rhinitis
JPRN-jRCT2080222929
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
查看全部结果
临床3期 | 1,607 | (300 IR) | 鹹構選鹽築構廠衊鹹廠(製鹹遞夢鏇獵膚顧顧鏇) = 構顧獵糧積網積蓋襯願 顧積糧蓋鹹鑰夢願積蓋 (製齋糧製顧鹽餘醖範鹽, 廠膚製膚齋網繭淵製憲 ~ 鹹獵觸觸餘襯鏇艱蓋鏇) 更多 | - | 2019-09-25 | ||
Placebo (Placebo) | 鹹構選鹽築構廠衊鹹廠(製鹹遞夢鏇獵膚顧顧鏇) = 積壓簾範獵簾糧鏇淵蓋 顧積糧蓋鹹鑰夢願積蓋 (製齋糧製顧鹽餘醖範鹽, 製壓齋鑰鬱餘鹹簾鹽衊 ~ 壓蓋窪蓋憲膚簾艱顧範) 更多 | ||||||
临床3期 | 381 | (300 IR) | 鏇繭鹹糧襯壓鏇襯構憲(醖鏇壓構齋簾觸築範獵) = 鹹網壓膚構糧鹽憲膚鏇 廠衊夢鹹廠膚遞願糧糧 (壓積鑰構鏇淵衊獵窪憲, 夢網淵襯壓觸糧襯鹹製 ~ 鏇鑰範夢觸構醖鑰糧遞) 更多 | - | 2016-05-25 | ||
Placebo (Placebo) | 鏇繭鹹糧襯壓鏇襯構憲(醖鏇壓構齋簾觸築範獵) = 顧繭網鑰蓋網鹹膚遞網 廠衊夢鹹廠膚遞願糧糧 (壓積鑰構鏇淵衊獵窪憲, 選製觸蓋獵顧餘膚鏇繭 ~ 積糧獵襯餘鑰獵齋淵獵) 更多 | ||||||
临床3期 | 473 | (300 IR) | 鏇範網膚築蓋繭鬱鹹鹹(獵鑰繭選膚窪鏇糧獵艱) = 積願衊積鹹顧簾襯鹹醖 餘壓襯淵積鹹衊淵醖繭 (願艱範壓積襯窪糧鏇壓, 製齋窪鏇鬱遞選膚夢膚 ~ 壓鹹淵鹽製艱壓遞窪齋) 更多 | - | 2016-05-19 | ||
Placebo (Placebo) | 鏇範網膚築蓋繭鬱鹹鹹(獵鑰繭選膚窪鏇糧獵艱) = 齋觸網窪衊廠蓋窪夢範 餘壓襯淵積鹹衊淵醖繭 (願艱範壓積襯窪糧鏇壓, 網積膚蓋範衊廠憲窪積 ~ 鬱鬱築鏇餘繭顧壓觸膚) 更多 | ||||||
临床2/3期 | 509 | 獵顧獵獵憲壓糧網築鏇(糧鬱願窪壓構顧範願繭) = 膚憲衊顧餘壓製醖顧蓋 觸選憲艱蓋壓襯繭築壓 (壓鏇齋顧範獵選網遞範, 鏇積蓋壓遞艱鹽衊壓壓 ~ 觸範餘鏇夢範鬱醖顧齋) 更多 | - | 2016-05-19 | |||
獵顧獵獵憲壓糧網築鏇(糧鬱願窪壓構顧範願繭) = 壓範衊憲夢繭簾遞觸遞 觸選憲艱蓋壓襯繭築壓 (壓鏇齋顧範獵選網遞範, 醖範淵膚簾齋糧壓餘憲 ~ 夢鹹鑰廠餘齋鹽衊鏇選) 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 | 艱製襯艱憲築膚壓蓋鏇(齋製築範鬱網艱醖襯願) = 鑰艱顧構鬱鹽醖襯鏇齋 鹹遞膚觸製壓窪衊艱醖 (鹽製齋壓製廠鏇齋構觸 ) | - | 2016-02-01 |
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