一项针对中度至重度银屑病参与者的 3 期研究 (UNCOVER-1)
2019年9月17日 更新者：Eli Lilly and Company
一项随机、双盲、安慰剂对照诱导给药期、随后随机维持给药期和长期延长期的多中心研究，以评估 LY2439821 在中度至重度斑块状银屑病患者中的疗效和安全性
本研究将评估 LY2439821 与安慰剂相比在中度至重度慢性斑块状银屑病参与者中的安全性和有效性。
研究概览
研究类型
介入性
注册 (实际的)
1296
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aarhus、丹麦、8000
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Hellerup、丹麦、2900
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Kobenhavn、丹麦、2400
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British Columbia
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Surrey、British Columbia、加拿大、V3R 6A7
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Manitoba
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Winnipeg、Manitoba、加拿大、R3C 1R4
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New Brunswick
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Moncton、New Brunswick、加拿大、E1C8X3
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B5H1Z4
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Ontario
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Ajax、Ontario、加拿大、L1S7K8
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Barrie、Ontario、加拿大、L4M6L2
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London、Ontario、加拿大、N6A 3H7
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Newmarket、Ontario、加拿大、L3Y6P5
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Richmond Hill、Ontario、加拿大、L4B 1A5
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Waterloo、Ontario、加拿大、N2J 1C4
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Windsor、Ontario、加拿大、N8W 1E6
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Quebec
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Montreal、Quebec、加拿大、H3Z 2S6
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Budapest、匈牙利、1036
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Debrecen、匈牙利、4032
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Miskolc、匈牙利、3529
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Szeged、匈牙利、H-6720
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Szolnok、匈牙利、H-5000
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Szombathely、匈牙利、H-9700
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Berlin、德国、13125
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Darmstadt、德国、64283
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Frankfurt、德国、60596
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Hamburg、德国、22143
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Hanau、德国、63450
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Hannover、德国、30449
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Kiel、德国、24105
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Köln、德国、50937
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Mahlow、德国、39110
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Mainz、德国、55131
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Münster、德国、48149
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Quedlinburg、德国、06484
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Wuppertal、德国、42275
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Bergamo、意大利、24128
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Bologna、意大利、40100
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Padova、意大利、35128
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Pisa、意大利、56126
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Aichi、日本、467-0001
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Fukuoka、日本、814-0180
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Kochi、日本、783-8505
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Kyoto、日本、602-0841
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Shiga、日本、520-2192
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Shizuoka、日本、431-3125
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Tochigi、日本、329- 0498
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Tokyo、日本、169-0073
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Bialystok、波兰、15-017
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Elblag、波兰、82-300
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Krakow、波兰、30-510
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Lodz、波兰、90-265
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Lublin、波兰、20-081
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Szczecin、波兰、70-111
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Torun、波兰、87-100
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Warsaw、波兰、04-749
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New South Wales
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Kogarah、New South Wales、澳大利亚、2217
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Queensland
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Benowa、Queensland、澳大利亚、4217
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Woolloogabba、Queensland、澳大利亚、4120
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South Australia
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Adelaide、South Australia、澳大利亚、5000
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Victoria
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Carlton、Victoria、澳大利亚、3053
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Parkville、Victoria、澳大利亚、3050
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Western Australia
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Fremantle、Western Australia、澳大利亚、6160
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Baia Mare、罗马尼亚、430193
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Bucharest、罗马尼亚、21155
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Craiova、罗马尼亚、200642
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Iasi、罗马尼亚、700125
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Alabama
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Birmingham、Alabama、美国、35233
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California
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Anaheim、California、美国、92801
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Bakersfield、California、美国、93309
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Fremont、California、美国、94538
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Connecticut
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New Haven、Connecticut、美国、06511
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Florida
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Jacksonville、Florida、美国、32216
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Miami、Florida、美国、33175
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Miramar、Florida、美国、33027
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Ocala、Florida、美国、34471
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Ormond Beach、Florida、美国、32174
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Pinellas Park、Florida、美国、33781
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Tampa、Florida、美国、33624
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West Palm Beach、Florida、美国、33409
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Georgia
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Atlanta、Georgia、美国、30327
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Illinois
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Arlington Heights、Illinois、美国、60005
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Chicago、Illinois、美国、60611
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Indiana
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Evansville、Indiana、美国、47714
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indianapolis、Indiana、美国、46256
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South Bend、Indiana、美国、46617
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Kentucky
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Owensboro、Kentucky、美国、42303
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Louisiana
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Baton Rouge、Louisiana、美国、70809
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Troy、Michigan、美国、48084
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Saint Louis、Missouri、美国、63117
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Bronx、New York、美国、10467
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York、New York、美国、10021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rochester、New York、美国、14623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Raleigh、North Carolina、美国、27612
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cleveland、Ohio、美国、44106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Portland、Oregon、美国、97223
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rhode Island
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Johnston、Rhode Island、美国、02919
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Knoxville、Tennessee、美国、37922
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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Salt Lake City、Utah、美国、84132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Bellingham、Washington、美国、98225
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seattle、Washington、美国、98101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lanarkshire、英国、ML6 0JS
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manchester
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Salford、Manchester、英国、M6 8HD
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Lincolnshire
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Scunthorpe、North Lincolnshire、英国、DN15 7BH
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Scotland
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Dundee、Scotland、英国、DD1 9SY
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Warwickshire
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Nuneaton、Warwickshire、英国、CV10 7BL
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 根据慢性寻常型银屑病的确诊诊断，在随机分组前至少 6 个月出现慢性斑块型银屑病
- 在筛选和随机化时至少有 10% 的银屑病体表面积 (BSA)
- 在筛选和随机分组时，静态医师整体评估 (sPGA) 得分至少为 3，银屑病面积和严重程度指数 (PASI) 得分至少为 12
- 光疗和/或全身治疗的候选人
- 男性必须同意在研究期间使用可靠的避孕方法
- 女性必须同意在研究期间和停止治疗后至少 12 周内使用节育措施或保持禁欲
排除标准：
- 脓疱型、红皮病型和/或滴状型银屑病
- 药物性银屑病病史
- 随机分组前 12 周内有临床意义的银屑病发作
- 同时或最近使用任何生物制剂
- 在过去 4 周内接受过全身性银屑病治疗 [如补骨脂素和紫外线 A (PUVA) 光疗] 或光疗；或在随机分组前 2 周内接受过局部银屑病治疗
- 在随机化之前和研究期间至少 4 周内无法避免过度日晒或使用晒黑间
- 参加过任何有关白细胞介素 (IL)-17 拮抗剂的研究，包括 LY2439821
- 斑块状银屑病以外的严重疾病或疾病
- 最近 3 个月内严重感染
- 母乳喂养或哺乳期（哺乳期）妇女。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：80 毫克 (mg) Ixekizumab 给药方案 1 (Q2W)
在第 0 周以两次 80 mg 皮下 (SC) 注射给药，然后每次给药方案 1 [每 2 周 (Q2W)] 给药一次 80 mg SC 注射，直至并包括第 10 周。
在第 12 周，将手臂重新随机分配至安慰剂、给药方案 2 [每 4 周 (Q4W)] 或给药方案 3 [每 12 周 Q12W)]。
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施行 SC
其他名称：
|
|
实验性的：80 mg Ixekizumab 给药方案 2 (Q4W)
在第 0 周以 2 次 80 mg SC 注射给药，然后在第 10 周（包括第 10 周）每个给药方案 2 (Q4W) 进行 1 次 80 mg SC 注射。
在第 12 周，将手臂重新随机分配至安慰剂、给药方案 2 (Q4W) 或给药方案 3 (Q12W)。
|
施行 SC
其他名称：
|
|
实验性的：80 mg Ixekizumab 给药方案 3 (Q12W)
给药方案 3 (Q12W) 直到第 12 周才使用。
在第 12 周，重新随机分配到该组的参与者接受了一次 80 毫克皮下注射 Q12W。
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施行 SC
其他名称：
|
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安慰剂比较：安慰剂
在第 0 周进行 2 次 SC 注射，然后每个给药方案 1 (Q2W) 进行 1 次 SC 注射，直至并包括第 10 周。
在第 12 周，将手臂重新随机分配至安慰剂或给药方案 2 (Q4W)。
|
施行SC
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
静态医师整体评估 (sPGA) 为 0 或 1 的参与者百分比（Ixekizumab 在具有中度至重度斑块 Ps 测量的参与者中的疗效：sPGA）
大体时间：第 12 周
|
SPGA 是医生在给定时间点对参与者 Ps 病变的总体确定。
根据硬结、红斑和脱屑的描述对病变进行分类。
参与者 Ps 被评估为 0（清除）、1（最小）、2（轻度）、3（中度）、4（严重）或 5（非常严重）。
sPGA 反应者被定义为具有“0”或“1”的基线后 sPGA 评分，并且至少比基线提高 2 分。
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第 12 周
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Ps 面积和严重程度指数 (PASI75) 达到 ≥ 75% 改善的参与者百分比
大体时间：第 12 周
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PASI 结合了 4 个解剖区域（头部、躯干、手臂和腿部）的体表受累程度。
对于每个区域，涉及的皮肤面积百分比估计为 0 (0%) 至 6 (90%-100%)，严重程度根据红斑、硬结和鳞屑的临床体征估计，评分范围为 0（无受累）至4（严重参与）。
每个领域单独评分，然后将分数合并为最终的 PASI。
最终 PASI 计算为：每个区域的严重性参数总和 * 区域得分 * 权重因子 [头部 (0.1)、上肢 (0.2)、躯干 (0.3)、下肢 (0.4)]。
总分范围从 0（无 Ps）到 72（最严重的疾病）。
达到 PASI75 的参与者被定义为与基线相比 PASI 评分提高 ≥ 75%。
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第 12 周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
实现 sPGA 为 0 的参与者百分比（Ixekizumab 在具有中度至重度斑块 Ps 测量的参与者中的功效：sPGA）
大体时间：第 12 周
|
SPGA 是医生在给定时间点对参与者 Ps 病变的总体确定。
根据硬结、红斑和脱屑的描述对病变进行分类。
参与者 Ps 被评估为 0（清除）、1（最小）、2（轻度）、3（中度）、4（严重）或 5（非常严重）。
|
第 12 周
|
|
达到 PASI 90% (PASI90) 或 100% (PASI100) 的参与者百分比
大体时间：第 12 周
|
PASI 结合了 4 个解剖区域（头部、躯干、手臂和腿部）的体表受累程度。
对于每个区域，涉及的皮肤面积百分比估计为 0 (0%) 至 6 (90%-100%)，严重程度根据红斑、硬结和鳞屑的临床体征估计，评分范围为 0（无受累）至4（严重参与）。
每个领域都单独评分，然后将分数合并为最终的 PASI。
最终 PASI 计算为：每个区域的严重性参数总和 * 区域得分 * 权重因子 [头部 (0.1)、上肢 (0.2)、躯干 (0.3)、下肢 (0.4)]。
总分范围从 0（无 Ps）到 72（最严重的疾病）。
与基线相比，达到 PASI90 或 PASI100 的参与者被定义为 PASI 分数分别提高 ≥ 90% 或 100%。
|
第 12 周
|
|
在维持剂量期开始时重新随机化后维持 sPGA 0 或 1 的参与者百分比
大体时间：第 60 周
|
SPGA 是医生在给定时间点对参与者 Ps 病变的总体确定。
根据硬结、红斑和脱屑的描述对病变进行分类。
参与者 Ps 被评估为 0（清除）、1（最小）、2（轻度）、3（中度）、4（严重）或 5（非常严重）。
|
第 60 周
|
|
瘙痒数字评定量表 (Itch NRS) 得分从基线减少 ≥ 4 分的参与者百分比
大体时间：基线，第 12 周
|
Itch NRS 是参与者管理的 11 点水平量表，固定在 0（不痒）和 10（可想象的最严重的痒）。
通过圈出最能描述过去 24 小时内最严重瘙痒程度的数字来表示参与者因 Ps 引起的瘙痒的总体严重程度。
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基线，第 12 周
|
|
皮肤科特定生活质量指数 (DLQI) 评分相对于基线的变化
大体时间：基线，第 12 周
|
DLQI 是一份由参与者管理、包含 10 个问题、经过验证的生活质量问卷，涵盖 6 个领域，包括症状和感受、日常活动、休闲、工作和学校、人际关系和治疗。
回答类别包括 0（完全不相关）、1（一点点）、2（很多）和 3（非常多），未回答（“不相关”）的回答计为“0”。
总分范围从 0 到 30，分数越高表明生活质量越差。
从基线的 5 点变化被认为是临床相关的。
使用混合模型重复测量 (MMRM) 计算相对于基线的最小二乘法 (LS) 平均变化。
|
基线，第 12 周
|
|
指甲银屑病严重程度指数 (NAPSI) 相对于基线的变化
大体时间：基线，第 12 周
|
NAPSI 是一种用于评估指甲 Ps 的数字、可重复、客观的工具。
该量表用于按指甲单位受累面积评估指甲床 Ps 和指甲基质 Ps 的严重程度。
指甲被假想的水平线和纵向线分成象限。
每个指甲的指甲床 Ps 0（无）到 4（指甲的 4 个象限中的 Ps）和指甲基质 Ps 0（无）到 4（矩阵的 4 个象限中的 Ps）的分数，取决于存在（每个象限中指甲床或基质 Ps 的任何特征得分为 1) 或缺失（得分为 0）。
指甲的 NAPSI 分数是每个象限的指甲床和指甲基质的分数之和（最大值为 8）。
评估每个手指甲，然后所有手指甲的总和等于总 NAPSI 评分，范围从 0 到 80，评分越高表明银屑病越严重。
使用 MMRM 计算相对于基线的 LS 平均变化。
|
基线，第 12 周
|
|
Ps 受累的体表面积 (BSA) 百分比
大体时间：第 12 周
|
BSA 是医生对每个参与者的 Ps 参与百分比的评级。
BSA 以从 0%（无参与）到 100%（完全参与）的连续尺度进行评估，其中 1% 对应于参与者手的大小（包括手掌、手指和拇指）。
总 BSA 是受影响区域的手印总和。
使用 MMRM 计算相对于基线的 LS 平均变化。
|
第 12 周
|
|
银屑病头皮严重程度指数 (PSSI) 相对于基线的变化
大体时间：基线，第 12 周
|
PSSI 是医生对红斑、硬化和脱屑的评估，以及被覆盖的头皮百分比，评分范围从 0（无）到 4（非常严重）。
综合评分由红斑、硬结和脱屑的评分总和乘以头皮受累范围的评分得出，1 (<10%) 至 6 (90%-100%) 总分范围从 0 到 72，分数越低表示严重程度越低。
使用 MMRM 计算相对于基线的 LS 平均变化。
|
基线，第 12 周
|
|
工作生产力活动损害问卷-银屑病 (WPAI-PSO) 生活质量和结果评估的所有分数相对于基线的变化。措施：参与者报告的结果（PRO）
大体时间：基线，第 12 周
|
WPAI-PSO 是参与者管理的 6 项工具，用于评估 Ps 在过去 7 天内对生产力损害的影响。
WPAI-PSO 有 4 个领域：缺勤率、出勤率（工作时生产力下降）、总体工作损伤分数和工作以外的日常活动损伤。
以百分比形式得出四个分数：旷工率、出勤率（工作时生产力下降）、整体工作障碍（旷工率和出勤率）以及工作以外活动的障碍。
百分比计算如下：每个分数 * 100，分数越高表示损伤越大。
使用协方差分析 (ANCOVA) 计算相对于基线的 LS 平均变化。
|
基线，第 12 周
|
|
抑郁症状快速盘点基线的变化-自我报告的 16 项 (QIDS-SR16)
大体时间：基线，第 12 周
|
QIDS-SR16 是一种参与者管理的 16 项工具，旨在评估抑郁症状的存在和严重程度。
参与者被要求考虑每个陈述，因为它与他们过去 7 天的感受方式相关，并以 4 分制对每个陈述进行评分：0（最好）到 3（最差）。
9个抑郁领域[悲伤情绪、注意力集中、自我批评、自杀意念、兴趣、精力/疲劳、睡眠障碍（初期、中期和晚期失眠或嗜睡）、食欲下降/增加/体重下降/增加]对应的16项总和和精神运动性激越/迟滞]给出的单一总分范围从 0 到 27，分数越高表示症状越严重。
使用 ANCOVA 计算相对于基线的 LS 平均变化。
|
基线，第 12 周
|
|
医疗结果研究基线的变化 36 项短期健康调查 (SF-36) 和身体成分总结 (PCS) 和心理成分总结 (MCS)
大体时间：基线，第 12 周
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SF-36 是一种自我报告的工具，用于测量参与者在过去 7 天内的健康状况。
它包括 36 个项目，涵盖 8 个领域：身体机能、身体角色、情感角色、身体疼痛、活力、社会功能、心理健康和一般健康。
项目在不同长度的李克特量表上回答。
这 8 个域在 PCS 和 MCS 分数中重新分组。
分数范围从 0 到 100，分数越高表示功能水平越好和/或健康状况越好。
使用 ANCOVA 计算相对于基线的 LS 平均变化。
|
基线，第 12 周
|
|
患者疾病严重程度总体评估 (PatGA) 相对于基线的变化
大体时间：基线，第 12 周
|
PatGA 是一项单项自我报告工具，要求参与者通过在数字评分量表上圈出从 0（无银屑病）到 5（严重 = 银屑病最严重）的数字来评价他们“今天”的银屑病严重程度曾经）。
使用 MMRM 计算的相对于基线的 LS 平均变化。
|
基线，第 12 周
|
|
实现掌跖 PASI (PPASI) ≥ 50% (PPASI50)、≥75% (PPASI75) 或 100% (PPASI100) 改善的参与者百分比
大体时间：第 12 周
|
掌跖 PASI 是一个综合评分，由红斑、硬化和脱屑的评分总和 [每个评分范围从 0（无）到 4（非常严重）] 乘以手掌和足底区域受累程度的评分得出[分数范围从 0（0%）到 6（90 到 100%）]，总分范围从 0 到 72。
与基线相比，达到 PPASI50、PPASI75 或 PASI100 的参与者被定义为 PPASI 分数分别提高至少 50%、90% 或 100%。
|
第 12 周
|
|
药代动力学 (PK)：稳态下的谷浓度（谷 ss）
大体时间：第 12 周：第 84 天和第 24 周：第 168 天
|
第 12 周：第 84 天和第 24 周：第 168 天
|
|
|
具有抗 ixekizumab 抗体的参与者百分比
大体时间：第 12 周的基线
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按治疗组总结治疗中出现阳性抗 ixekizumab 抗体的参与者百分比。
百分比是根据可评估参与者的数量计算的，并通过具有治疗中出现阳性抗 ixekizumab 抗体的参与者数量/可评估参与者数量 * 100% 计算得出。
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第 12 周的基线
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
- Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
- Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.
- Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年11月16日
初级完成 (实际的)
2014年6月24日
研究完成 (实际的)
2018年9月20日
研究注册日期
首次提交
2011年11月15日
首先提交符合 QC 标准的
2011年11月17日
首次发布 (估计)
2011年11月18日
研究记录更新
最后更新发布 (实际的)
2019年10月3日
上次提交的符合 QC 标准的更新
2019年9月17日
最后验证
2019年1月18日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的