Short ragweed pollen allergen extract(ALK-Abello A/S)(Short ragweed pollen allergen extract(ALK-Abello A/S)) - 在研适应症：变应性结膜炎，结膜炎，过敏性鼻炎_专利_临床

A Randomized Comparative Clinical Study to Evaluate the Efficacy of Rasona Vati (Allium sativum) and Shuddha Guggulu Vati (Commiphora mukul) in the management of Gridhrasi.

开始日期2023-04-11

申办/合作机构-

NCT05119751 / Completed临床4期IIT

An Investigator-initiated Single Center Randomised Clinical Pilot Study to Compare Tolerability of the Sublingual Versus Vestibular Administration Routes for Birch Pollen, Grass Pollen, Ragweed Pollen, or House Dust Mite Allergy Immunotherapy (AIT)

To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)

开始日期2021-10-25

申办/合作机构

ALK-Abello A/S

NCT04176185 / Terminated临床3期

A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber

This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

开始日期2019-11-04

申办/合作机构

ALK-Abello A/S

100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的临床结果

登录后查看更多信息

100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的转化医学

登录后查看更多信息

100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的专利（医药）

登录后查看更多信息

11

项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的文献（医药）

2021-12-01·Allergy, Asthma & Clinical Immunology4区 · 医学

Randomized controlled trial of ragweed sublingual immunotherapy tablet in the subpopulation of Canadian children and adolescents with allergic rhinoconjunctivitis

4区 · 医学

ArticleOA

作者: Nolte, Hendrik ; Ellis, Anne K ; Gagnon, Remi ; Bernstein, David I

AbstractBackgroundPost hoc analyses of randomized placebo-controlled trials have demonstrated efficacy and tolerability of the ragweed sublingual immunotherapy (SLIT)-tablet in Canadian adults with ragweed pollen-induced allergic rhinitis/conjunctivitis (AR/C). This post hoc analysis evaluated the efficacy and tolerability of the ragweed SLIT-tablet in the subpopulation of Canadian children and adolescents with AR/C in a previously described randomized, double-blind, placebo-controlled trial.MethodsThe trial (NCT02478398) was conducted in North American and European children/adolescents ages 5–17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥ 80% predicted). Participants were randomized to daily ragweed SLIT-tablet (12 Amb a 1-U) or placebo for up to 28 weeks. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary endpoints were TCS during the entire RPS, and DSS and DMS during peak RPS. Post hoc analyses of the primary and key secondary endpoints were conducted in the subpopulation of Canadian participants.ResultsOf the 1025 randomized participants, 246 (SLIT-tablet, n = 116; placebo, n = 130) were in the Canadian subpopulation. In the total study population, relative TCS (95% CI) improvement with ragweed SLIT-tablet versus placebo was − 38.3% (− 46.0%, − 29.7%; least square [LS] mean difference, − 2.73; P < 0.001) during peak RPS. In the Canadian subpopulation, relative TCS improvements with ragweed SLIT-tablet versus placebo were − 40.8% (− 54.5%, − 20.2%; LS mean difference, − 1.59; P = 0.001) during peak RPS and − 36.6% (− 50.2%, − 16.5%; LS mean difference, − 1.36; P = 0.002) during the entire RPS. DSS and DMS during peak RPS in the Canadian subpopulation improved with SLIT-tablet versus placebo by − 30.6% (− 45.2%, − 7.7%; LS mean difference, − 0.94; P = 0.010) and − 77.2% (− 97.5%, − 44.2%; LS mean difference, − 0.66; P = 0.003), respectively. No events of anaphylaxis, airway compromise, intramuscular epinephrine administration, eosinophilic esophagitis, or severe treatment-related systemic allergic reactions were reported in the overall population or Canadian subpopulation.ConclusionEfficacy and safety of the ragweed SLIT-tablet in Canadian children/adolescents with ragweed pollen-induced AR/C was consistent with the total study population. The ragweed SLIT-tablet resulted in clinically meaningful improvement in symptoms, decreased symptom-relieving medication use, and was well tolerated in Canadian children/adolescents.Trial registration: clinicaltrials.gov, NCT02478398. Registered June 23, 2015, https://clinicaltrials.gov/ct2/show/NCT02478398?term=NCT02478398&draw=2&rank=1

2020-12-01·PharmacoEconomics - Open

Application of a Mapping Function to Estimate Utilities for Ragweed Allergy Immunotherapy Trials

Article

作者: Brandi, Henrik ; Briggs, Andrew ; Dick, Katherine

BACKGROUNDRagweed pollen sensitivity is a common cause of allergic rhinitis (AR) worldwide. AR symptoms include itchy and runny eyes, sneezing, blocked nose, impaired sleep and social and emotional problems, which can have a significant impact on quality of life.OBJECTIVEThe objective of this analysis was to estimate utilities for two pooled standardised quality (SQ) ragweed sublingual immunotherapy (SLIT) tablet trials by applying a previously developed mapping algorithm. This study validated the algorithm and extended its application to ragweed seasonal allergy trials. The mapping algorithm relates disease-specific quality-of-life scores to preference-based utilities that may be used to calculate quality-adjusted life-years (QALYs) in cost-effectiveness studies.METHODSA mapping algorithm based on a grass pollen allergy immunotherapy trial, GT-08 (EudraCT no. 2004-000083-27) was applied to pooled data from two ragweed pollen immunotherapy trials, P05233 (EudraCT 2008-003863-38) and P05234 (EudraCT 2008-003864-20) to generate EuroQoL 5-Dimensions, 3-Levels (EQ-5D-3L) utilities from Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) data.RESULTSThe mean utility difference between the SQ ragweed SLIT tablet and placebo was 0.025 [95% confidence interval (CI) 0.011-0.038]. The SQ ragweed SLIT tablet showed an incremental quality-adjusted life-days (QALDs) benefit of 1.900 (95% CI 0.835-2.916) over 75 days.CONCLUSIONSApplication of a previously developed mapping function allowed for the calculation of QALDs associated with the SQ ragweed SLIT tablet. The results showed a QALD benefit of the SQ ragweed SLIT tablet in P05233 and P05234 trials in the treatment of ragweed pollen-induced AR.

2020-07-01·The Journal of Allergy and Clinical Immunology: In Practice1区 · 医学

Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial

1区 · 医学

Article

作者: Nelson, Harold S ; Ellis, Anne K ; Nolte, Hendrik ; Bernstein, David I ; Lu, Susan ; Kleine-Tebbe, Jörg

BACKGROUNDRagweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.OBJECTIVEThis international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.METHODSChildren (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV₁ ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.RESULTSRelative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.CONCLUSIONSRagweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.

2

项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的新闻（医药）

2024-01-18

·GlobeNewswire-Health Care

ALK completes first part of phase 1 trial with peanut SLIT-tablet

The trial now progresses into its second part, expected to complete later in 2024. ALK to submit a protocol amendment for Phase 1-2 efficacy trial extension. ALK (ALKB:DC / OMX: ALK B / AKBLF) announced today that it has completed the first part of its phase 1 clinical trial (named ‘ALLIANCE’) for its investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy. The first part of the trial investigated the safety and tolerability of 14 days treatment with the peanut tablet at different starting doses. For all dose levels, the peanut tablet was shown to be safe and tolerable and with a safety and tolerability profile in accordance with that of the approved SLIT-tablets (ACARIZAX/ODACTRA®, GRAZAX®/GRASTEK®, RAGWIZAX®/RAGWITEK®, ITULAZAX®/ITULATEK®). No serious adverse events and no cases of treatment emergent anaphylaxis were reported. Based on results from part 1, the starting dose for the second part of the study has been selected. This part of the study will evaluate the safety and tolerability of up-dosing to the highest tolerable maintenance dose. The second part will be initiated imminently and is scheduled to complete later in 2024. Furthermore, ALK has decided to amend the ALLIANCE study protocol to include a third part involving approximately 100 additional patients. This part will evaluate safety and efficacy of the peanut SLIT-tablet as assessed by an oral food challenge following a period of maintenance treatment. The implementation of the third part is contingent upon a successful outcome of the second part. The revised protocol is expected soon to be submitted to the relevant authorities. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “We are pleased to report positive progress in our ALLIANCE trial, addressing potentially life-threatening peanut allergy. Encouraged by the initial results for the peanut tablet, we have made a provisional decision to extend the trial into a seamless Phase 1-2 design allowing us to explore the efficacy of the tablet as well. Leveraging our profound R&D expertise, we remain committed to developing valuable new treatment options for people with allergy”. In the USA, peanut allergy affects up to 1.5 million children and adolescents aged 4-17, while in Europe, around 1 million children and adolescents are affected by this potentially life-threatening condition. The disease often presents in early childhood and can last a lifetime. For some of these patients, allergy immunotherapy may become a relevant treatment option with the potential to improve quality of life, both for them and their families. This announcement is not expected to materially change the R&D cost outlook for 2024-25. ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation. About the ALLIANCE trialInitiated in 2022, the ALLIANCE trial was designed to assess the tolerability and safety of an up-dosing regimen with a once-daily peanut SLIT-tablet in adults, adolescents, and children. The trial is a phase I, open-label, dose-escalation, multi-site trial conducted in North America, with approximately 100 participants with peanut allergy confirmed by screening via a double-blind, placebo-controlled food challenge. The first part of the trial aimed at determining the starting dose of the up-dosing regimen and the second part to assess safety and tolerability of the up-dosing regimen as well as gather early data on its biological action. The third part intends to investigate safety and efficacy of selected doses of the peanut SLIT-tablet compared with placebo. The trial marked the formal start of ALK’s clinical development of a novel food allergy treatment which uses the same technology as ALK’s SLIT tablets for respiratory allergies. About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment FM_01_2024UK_18012024

免疫疗法临床1期

2021-04-19

·BioSpace

U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis About ALK ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and doctors. Headquartered in Hørsholm, Denmark, the company employs around 2,500 people worldwide and is listed on Nasdaq Copenhagen. To learn more about ALK and allergies, visit . For further information, please contact: ALK: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Stuart Loesch, tel. +1 908 842 8363, mobile +1 267 753 5838 View original content to download multimedia: SOURCE ALK, INC.

免疫疗法

100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	V01AA02	-

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
变应性结膜炎	俄罗斯	ALK-Abello A/S	2019-12-31
结膜炎	美国	ALK-Abello A/S	2014-04-17
结膜炎	美国	Merck Sharp & Dohme Corp.	2014-04-17
过敏性鼻炎	美国	Merck Sharp & Dohme Corp.	2014-04-17
过敏性鼻炎	美国	ALK-Abello A/S	2014-04-17
季节性过敏性鼻炎	法国	-	2012-01-01

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
过敏	临床前	丹麦	ALK-Abello A/S	2004-10-01
鼻结膜炎	临床前	丹麦	ALK-Abello A/S	2004-10-01
哮喘	药物发现	-	Merck Sharp & Dohme Corp.	2015-07-20
豚草过敏	药物发现	-	ALK-Abello A/S	2011-11-01
过敏性鼻炎伴哮喘	药物发现	-	ALK-Abello A/S	2009-09-01
过敏性鼻结膜炎	药物发现	-	ALK-Abello A/S	2009-09-01
结膜炎	药物发现	-	Lundbeckfonden	2009-09-01
过敏性鼻炎	药物发现	-	Lundbeckfonden	2009-09-01
过敏性鼻炎	药物发现	-	ALK-Abello A/S	2009-09-01
季节性过敏性鼻炎	药物发现	丹麦	ALK-Abello A/S	2004-10-01

登录后查看更多信息

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


NCT02478398 (CTgov)	临床3期	季节性过敏性鼻炎 \| 哮喘 \| 过敏性鼻结膜炎	1,025	Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine+Short ragweed pollen allergen extract (Short Ragweed Pollen Allergen Extract)	構製糧窪夢繭襯簾淵鹽(觸鬱齋窪願憲選網衊簾) = 網觸願獵艱顧衊鏇夢鬱遞築廠夢膚膚壓獵壓製 (夢獵獵餘衊遞遞淵廠衊, 壓範鹹遞製餘鬱範淵獵 ~ 鹽鹽醖齋構淵壓築鹹壓) 更多	-	2019-07-09
				Placebo+Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine (Placebo)	構製糧窪夢繭襯簾淵鹽(觸鬱齋窪願憲選網衊簾) = 顧獵壓鏇襯構衊觸醖窪遞築廠夢膚膚壓獵壓製 (夢獵獵餘衊遞遞淵廠衊, 衊繭膚蓋鹹壓積齋夢膚 ~ 獵鏇觸鹹積廠窪醖觸簾) 更多
NCT02256553 (P08607, CTgov)	临床4期	季节性过敏性鼻炎 \| 结膜炎	102	MK-7243+MK-3641 (MK-3641+MK-7243)	鬱積夢衊選壓繭鏇淵構(遞淵衊遞餘願膚壓遞夢) = 憲範鏇襯糧遞積簾艱觸齋糧壓壓艱廠獵蓋遞構 (齋積窪襯獵獵築範選餘, 選遞製憲壓鹹鏇鬱積觸 ~ 獵衊膚繭製鬱淵遞鬱艱) 更多	-	2016-01-18
				MK-7243 (Period I: MK-7243)	積願遞鏇醖選憲選膚糧(觸淵襯鹽齋糧範糧鹽範) = 蓋糧觸衊選繭醖獵積齋鑰製鑰獵製鏇網憲顧衊 (繭蓋範鹹蓋淵繭願窪憲, 鹹觸範簾醖齋築窪網觸 ~ 廠艱範獵窪鏇鑰窪構構) 更多
NCT00783198 (P05233, CTgov)	临床2/3期	过敏性鼻结膜炎 \| 过敏性鼻炎伴哮喘	565	SCH 39641 6 Amb a 1-U (SCH 39641 6 Amb a 1-U)	選觸糧艱窪繭淵齋淵餘(艱襯構憲憲網範鏇蓋繭) = 糧壓構構壓齋顧製糧製醖壓範構範壓艱鏇鑰糧 (壓廠遞艱醖衊製鹽糧齋, 獵遞醖築顧糧鏇膚襯遞 ~ 糧簾夢鹹範鑰鑰繭鬱製) 更多	-	2014-07-14
				SCH 39641 12 Amb a 1-U (SCH 39641 12 Amb a 1-U)	選觸糧艱窪繭淵齋淵餘(艱襯構憲憲網範鏇蓋繭) = 艱淵構顧鬱製鑰艱壓築醖壓範構範壓艱鏇鑰糧 (壓廠遞艱醖衊製鹽糧齋, 艱鏇顧壓簾築選築築遞 ~ 鏇衊獵鬱獵夢簾襯構顧) 更多
NCT01469182 (P05751, CTgov)	临床3期	豚草过敏 \| 过敏	914	SCH 39641 (SCH 39641 12 Amb a 1-U)	鏇窪遞鹽餘鏇構簾願蓋(廠醖艱遞廠觸繭觸遞鹽) = 膚餘製鏇醖淵醖醖憲積廠夢憲鹹襯鏇襯獵淵餘 (簾願醖獵蓋衊獵構鹽齋, 膚壓糧築襯鑰積製鬱顧 ~ 襯蓋鑰鹹蓋憲觸觸願餘) 更多	-	2014-06-05
				Placebo for SCH 39641 (Placebo)	鏇窪遞鹽餘鏇構簾願蓋(廠醖艱遞廠觸繭觸遞鹽) = 蓋蓋淵艱顧憲顧鑰窪構廠夢憲鹹襯鏇襯獵淵餘 (簾願醖獵蓋衊獵構鹽齋, 顧襯鬱網鹹蓋範糧夢齋 ~ 衊蓋膚壓鏇襯遞遞構膚) 更多
NCT00978029 (P06081, CTgov)	临床2期	鼻结膜炎 \| 过敏性鼻结膜炎 \| 过敏	203	Placebo (Placebo)	顧鬱夢艱鬱製積構鬱鏇(鑰憲窪觸壓齋顧衊積選) = 窪齋齋觸窪窪夢憲顧觸憲製構壓鹹積顧齋鏇範 (憲窪艱製淵廠遞觸鹽壓, 淵艱襯艱積憲築製廠鬱 ~ 蓋廠鹽齋築壓衊壓糧餘) 更多	-	2014-05-23
				SCH 39641 (SCH 39641 6 Amb a 1-U)	顧鬱夢艱鬱製積構鬱鏇(鑰憲窪觸壓齋顧衊積選) = 蓋襯蓋繭餘鬱製鏇夢選憲製構壓鹹積顧齋鏇範 (憲窪艱製淵廠遞觸鹽壓, 襯夢糧糧鏇築餘鑰積繭 ~ 繭願顧鑰繭艱願鹹鑰鏇) 更多