编号/登记号：
NCT04157335
注册时间：
2019-11-08
研究开始时间：
2019-11-25
研究结束时间：
2025-10-10
项目类型：
clinicaltrials临床试验
本院角色：
牵头单位
多中心研究：
国际多中心
参与国家：
Argentina;Australia;Belgium;Bulgaria;Chile;France;Hungary;Italy;Japan;Poland;Russian Federation;Sweden;Taiwan;Thailand;Turkey;United States;Vietnam
招募状态：
Recruiting
试验分期：
III期
研究疾病/适应症：
Nasal Polyposis
研究类型：
Interventional
研究单位：
[1]Beijing Tongren Hospital
[2]AstraZeneca
[3]Research Site,Fresno,California,United States,93720
[4]Research Site,Huntington Beach,California,United States,92647
[5]Research Site,Stockton,California,United States,95207
[6]Research Site,Grand Junction,Colorado,United States,81501
[7]Research Site,Gainesville,Florida,United States,32605
[8]Research Site,Lake Mary,Florida,United States,32746
[9]Research Site,Anderson,Indiana,United States,46016
[10]Research Site,Kansas City,Kansas,United States,66160
[11]Research Site,Louisville,Kentucky,United States,40220
[12]Research Site,White Marsh,Maryland,United States,21162
[13]Research Site,Boston,Massachusetts,United States,02111
[14]Research Site,Missoula,Montana,United States,59808
[15]Research Site,Bronx,New York,United States,10461
[16]Research Site,White Plains,New York,United States,10605
[17]Research Site,Cleveland,Ohio,United States,44195
[18]Research Site,Tulsa,Oklahoma,United States,74136
[19]Research Site,Bethlehem,Pennsylvania,United States,18017
[20]Research Site,Philadelphia,Pennsylvania,United States,19107
[21]Research Site,Fort Worth,Texas,United States,76109
[22]Research Site,McKinney,Texas,United States,75070
[23]Research Site,Saint George,Utah,United States,84790
[24]Research Site,Richmond,Virginia,United States,23235
[25]Research Site,Bellingham,Washington,United States,98225
[26]Research Site,Milwaukee,Wisconsin,United States,53228
[27]Research Site,Buenos Aires,Argentina,C1121 ABE
[28]Research Site,Buenos Aires,Argentina,C1414AIF
[29]Research Site,Ciudad de Buenos Aire,Argentina,C1425BEN
[30]Research Site,San Fernando,Argentina,B1646EBJ
[31]Research Site,Herston,Australia,4029
[32]Research Site,Melbourne,Australia,3004
[33]Research Site,Spearwood,Australia,6163
[34]Research Site,Bruxelles,Belgium,1200
[35]Research Site,Gent,Belgium,9000
[36]Research Site,Leuven,Belgium,3000
[37]Research Site,Plovdiv,Bulgaria,4001
[38]Research Site,Sofia,Bulgaria,1303
[39]Research Site,Sofia,Bulgaria,1606
[40]Research Site,Quillota,Chile,2260000
[41]Research Site,Santiago,Chile,7500588
[42]Research Site,Santiago,Chile,8150000
[43]Research Site,Talca,Chile,3465584
[44]Research Site,Beijing,China,100044
[45]Research Site,Beijing,China,100191
[46]Research Site,Beijing,China,100730
[47]Research Site,Changchun,China,130061
[48]Research Site,Changsha,China,410008
[49]Research Site,Changsha,China,410013
[50]Research Site,Changsha,China
[51]Research Site,Chengdu,China,610041
[52]Research Site,Chengdu,China,610072
[53]Research Site,Chongqing,China,400042
[54]Research Site,Foshan,China,528000
[55]Research Site,Guangzhou,China,510000
[56]Research Site,Guangzhou,China,510180
[57]Research Site,Hangzhou,China,310003
[58]Research Site,Jinan,China,250014
[59]Research Site,Nanchang,China,330006
[60]Research Site,Nanjing,China,210029
[61]Research Site,Nanning,China,530021
[62]Research Site,Qingdao,China,266071
[63]Research Site,Shanghai,China,200065
[64]Research Site,Shanghai,China,200092
[65]Research Site,Tianjin,China,300052
[66]Research Site,Urumqi,China,830054
[67]Research Site,Wuhan,China,430022
[68]Research Site,Xi'an,China,710004
[69]Research Site,Xian,China,710061
[70]Research Site,Yantai,China,264000
[71]Research Site,Le Kremlin Bicetre,France,94275
[72]Research Site,Lille,France,59037
[73]Research Site,Marseille,France,13005
[74]Research Site,Nantes CEDEX 1,France,44093
[75]Research Site,Toulouse CEDEX 09,France,31059
[76]Research Site,Budapest,Hungary,1033
[77]Research Site,Budapest,Hungary,1046
[78]Research Site,Gyöngyös,Hungary,3200
[79]Research Site,Győr,Hungary,9024
[80]Research Site,Kaposvár,Hungary,7400
[81]Research Site,Siófok,Hungary,8600
[82]Research Site,Szombathely,Hungary,9700
[83]Research Site,Székesfehérvár,Hungary,8000
[84]Research Site,Tatabánya,Hungary,2800
[85]Research Site,Bologna,Italy,40138
[86]Research Site,Catanzaro,Italy,88100
[87]Research Site,Milano,Italy,20156
[88]Research Site,Pisa,Italy,56124
[89]Research Site,Roma,Italy,00161
[90]Research Site,Roma,Italy,00168
[91]Research Site,Varese,Italy,21100
[92]Research Site,Chiba-shi,Japan,262-0015
[93]Research Site,Fujisawa-shi,Japan,251-0052
[94]Research Site,Hiroshima-shi,Japan,734-8551
[95]Research Site,Ichikawa-shi,Japan,272-0143
[96]Research Site,Iida-shi,Japan,395-8505
[97]Research Site,Kawasaki-shi,Japan,211-0063
[98]Research Site,Kumamoto-shi,Japan,860-0814
[99]Research Site,Meguro-ku,Japan,153-0061
[100]Research Site,Meguro-ku,Japan,153-8515
[101]Research Site,Minato-ku,Japan,105-8471
[102]Research Site,Moriguchi-shi,Japan,570-0074
[103]Research Site,Nagaoka-shi,Japan,940-2085
[104]Research Site,Osaka-shi,Japan,540-0008
[105]Research Site,Shinjuku-ku,Japan,160-0017
[106]Research Site,Yoshida-gun,Japan,910-1193
[107]Research Site,Bydgoszcz,Poland,85-231
[108]Research Site,Cieszyn,Poland,43-400
[109]Research Site,Elbląg,Poland,82-300
[110]Research Site,Katowice,Poland,40-282
[111]Research Site,Kraków,Poland,31-513
[112]Research Site,Lublin,Poland,20-552
[113]Research Site,Nadarzyn,Poland,05-830
[114]Research Site,Poznań,Poland,60-537
[115]Research Site,Poznań,Poland,60-805
[116]Research Site,Wrocław,Poland,53-301
[117]Research Site,Zawadzkie,Poland,47-120
[118]Research Site,Łodź,Poland,90-153
[119]Research Site,Izhevsk,Russian Federation,426061
[120]Research Site,Penza,Russian Federation,440067
[121]Research Site,Saint-Petersburg,Russian Federation,196158
[122]Research Site,Saratov,Russian Federation,410028
[123]Research Site,Lund,Sweden,221 85
[124]Research Site,Örebro,Sweden,70185
[125]Research Site,Taipei City,Taiwan,110
[126]Research Site,Taipei City,Taiwan,11217
[127]Research Site,Taipei City,Taiwan,114
[128]Research Site,Taipei,Taiwan,10002
[129]Research Site,Taipei,Taiwan,235
[130]Research Site,Taoyuan,Taiwan,333
[131]Research Site,Bangkok,Thailand,10330
[132]Research Site,Bangkok,Thailand,10400
[133]Research Site,Bangkok,Thailand,10700
[134]Research Site,Chiang Mai,Thailand,50200
[135]Research Site,Khon Kaen,Thailand,40002
[136]Research Site,Phitsanulok,Thailand,65000
[137]Research Site,Ankara,Turkey,06100
[138]Research Site,Aydin,Turkey,09100
[139]Research Site,Bakirkoy,Turkey,34147
[140]Research Site,Izmir,Turkey,35340
[141]Research Site,Malatya,Turkey,44280
[142]Research Site,Hanoi,Vietnam,100000
[143]Research Site,Ho Chi Minh City,Vietnam,70000
[144]Research Site,Ho Chi Minh,Vietnam,700000
[145]Research Site,Ho Chi Minh,Vietnam,700000
[146]Research Site,Hochiminh,Vietnam,700000
[147]Research Site,Hochiminh,Vietnam,70000
关键词：
Benralizumab
Nasal Polyposis
Eosinophilic Chronic Rhinosinusitis with Nasal Polyposis
Nasal Polyps
Asthma
研究目的：
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.
