一项针对中度至重度银屑病参与者的研究 (UNCOVER-3) (UNCOVER-3)
2020年7月17日 更新者：Eli Lilly and Company
一项为期 12 周的多中心、随机、双盲、安慰剂对照研究，比较 LY2439821 与依那西普和安慰剂在长期延长期的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 ixekizumab (LY2439821) 与依那西普和安慰剂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)
1346
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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Krasnodar、俄罗斯联邦、350020
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Moscow、俄罗斯联邦、127473
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Saint Petersburg、俄罗斯联邦、194356
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Sankt-Peterburg、俄罗斯联邦、195112
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Smolensk、俄罗斯联邦、214019
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Yaroslavl、俄罗斯联邦、150002
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Plovdiv、保加利亚、4000
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Sofia、保加利亚、1632
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Varna、保加利亚、9010
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Alberta
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Calgary、Alberta、加拿大、T3A 2N1
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z-3Y1
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H0A2
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Ontario
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Brampton、Ontario、加拿大、L6R 0W3
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Ottawa、Ontario、加拿大、K2G 6E2
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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、N8W5L7
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Quebec
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Drummondville、Quebec、加拿大、J2B 5L4
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Montreal、Quebec、加拿大、H2K4L5
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Budapest、匈牙利、1036
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Debrecen、匈牙利、4032
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Kecskemet、匈牙利、6000
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Mako、匈牙利、6900
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Miskolc、匈牙利、3529
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Oroshaza、匈牙利、5900
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Pecs、匈牙利、7632
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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、9700
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Veszprem、匈牙利、8200
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Monterrey、墨西哥、64460
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Augsburg、德国、86179
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Berlin、德国、13125
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Bonn、德国、53111
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Dresden、德国、01069
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Erfurt、德国、99084
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Ergolding、德国、84038
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Frankfurt、德国、60596
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Freiburg、德国、79100
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Freising、德国、85354
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Friedrichshafen、德国、88045
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Gera、德国、07548
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Hamburg、德国、20253
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Hanau、德国、63450
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Kiel、德国、24148
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Leipzig、德国、04103
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Mahlow、德国、15831
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Mainz、德国、55131
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Mannheim、德国、68167
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Mönchengladbach、德国、41236
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Münster、德国、48159
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Northeim、德国、37154
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Schwerin、德国、19055
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Würzburg、德国、97080
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Santiago、智利、8420383
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Bialystok、波兰、15-017
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Krakow、波兰、30-510
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Warsaw、波兰、02-201
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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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Bell Gardens、California、美国、90201
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Beverly Hills、California、美国、90212
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Irvine、California、美国、92697
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Los Angeles、California、美国、90045
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Oceanside、California、美国、92056
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San Diego、California、美国、92123
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Santa Monica、California、美国、90404
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Colorado
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Aurora、Colorado、美国、80045
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Connecticut
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New Haven、Connecticut、美国、06511
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Florida
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Edgewater、Florida、美国、32132
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Jacksonville、Florida、美国、32216
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Miami、Florida、美国、33144
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Ocala、Florida、美国、34471
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Ormond Beach、Florida、美国、32174
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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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Skokie、Illinois、美国、60077
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Indiana
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Indianapolis、Indiana、美国、46256
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Iowa
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West Des Moines、Iowa、美国、50265
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Kentucky
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Louisville、Kentucky、美国、40217
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Owensboro、Kentucky、美国、42303
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Massachusetts
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Boston、Massachusetts、美国、02111
- 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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Ann Arbor、Michigan、美国、48109
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Nebraska
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Omaha、Nebraska、美国、68144
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Nevada
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Henderson、Nevada、美国、89074
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New Hampshire
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Newington、New Hampshire、美国、03801
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New Jersey
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East Windsor、New Jersey、美国、08520
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New Mexico
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Albuquerque、New Mexico、美国、87106
- 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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New York、New York、美国、10075
- 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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Stony Brook、New York、美国、11790
- 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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High Point、North Carolina、美国、27262
- 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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Winston-Salem、North Carolina、美国、27157
- 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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Pennsylvania
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Hazleton、Pennsylvania、美国、18201
- 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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South Carolina
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Anderson、South Carolina、美国、29621
- 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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Texas
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Dallas、Texas、美国、75246
- 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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San Antonio、Texas、美国、78229
- 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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West Jordan、Utah、美国、84088
- 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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Buenos Aires、阿根廷、C1055AA0
- 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.
-
Ciudad Autónoma De Buenosaire、阿根廷、C1199ABD
- 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：
- 根据随机化前至少 6 个月的慢性银屑病确诊诊断患有慢性斑块状银屑病
- 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
- 男性必须同意使用可靠的避孕方法或在研究期间保持禁欲
- 女性必须同意在研究期间和停止治疗后至少 12 周内使用可靠的避孕措施或保持禁欲
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
- 先前使用依那西普
- 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 周内接受过非生物系统性银屑病治疗或光疗（包括补骨脂素和紫外线 A [PUVA]、紫外线 B [UVB]）；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
- 参加过任何使用白细胞介素 17 (IL-17) 拮抗剂（包括 ixekizumab）的研究
- 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
- 哺乳期或哺乳期（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 |
|---|---|
|
安慰剂比较：安慰剂
Ixekizumab 的安慰剂在第 0 周通过两次 SC 注射给药，然后每个给药方案 1 一次 SC 注射直至第 12 周。依那西普的安慰剂通过从第 0 周开始至第 12 周每周两次 1 次 SC 注射给药。
在第 12 周，参与者被分配到给药方案 2。
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施行SC
|
|
有源比较器：50 毫克依那西普
从第 0 周开始至第 12 周，每周两次通过 SC 注射给药。
在第 12 周，手臂被分配到给药方案 2
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施行 SC
|
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实验性的：80 mg ixekizumab 给药方案 2
在第 0 周通过两次 80 mg SC 注射给药，然后每个给药方案 2 一次 80 mg SC 注射给药直至第 264 周。
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施行 SC
其他名称：
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实验性的：80 mg ixekizumab 给药方案 1
在第 0 周通过两次 80 毫克 (mg) 皮下 (SC) 注射给药，然后按照给药方案 1 进行一次 80 mg SC 注射直至第 12 周。
在第 12 周，手臂被分配到给药方案 2。
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施行 SC
其他名称：
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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 |
|---|---|---|
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达到 (0, 1) 的静态医师整体评估 (sPGA) 的参与者人数（Ixekizumab 在患有中度至重度慢性斑块状银屑病的参与者中的疗效。测量：sPGA）
大体时间：第 12 周
|
SPGA 是医生在给定时间点根据硬结、红斑和脱屑的描述对参与者的总体银屑病病变进行的测定。
对于反应分析，参与者的牛皮癣被评估为清晰 (0)、最小 (1)、轻微 (2)、中度 (3)、严重 (4) 或非常严重 (5)。
sPGA (0,1) 反应定义为基线后 sPGA 评分为 0 或 1。
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第 12 周
|
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达到银屑病面积和严重程度指数 ≥75% (PASI 75) 改善的参与者人数（Ixekizumab 在患有中度至重度慢性斑块状银屑病的参与者中的疗效。测量：PASI）
大体时间：第 12 周
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PASI 综合评估了 4 个解剖区域（头部、躯干、手臂和腿部）的体表受累程度以及每个区域的脱屑（脱屑）、红斑和斑块硬化/浸润（厚度）的严重程度，得出无银屑病的总体评分为 0，最严重的疾病为 72。
达到 PASI 75 的参与者被定义为与基线相比，PASI 分数至少提高了 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 |
|---|---|---|
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达到 sPGA 的参与者人数 (0)
大体时间：第 12 周
|
SPGA 是医生在给定时间点根据硬结、红斑和脱屑的描述对参与者的总体银屑病病变进行的测定。
对于反应分析，参与者的牛皮癣被评估为清晰 (0)、最小 (1)、轻微 (2)、中度 (3)、严重 (4) 或非常严重 (5)。
sPGA (0) 反应定义为基线后 sPGA 评分为 0。
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第 12 周
|
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达到 ≥ 90% (PASI 90) 改善的参与者人数（Ixekizumab 在患有中度至重度慢性斑块状银屑病的参与者中的疗效。测量：PASI）
大体时间：第 12 周
|
PASI 综合评估了 4 个解剖区域（头部、躯干、手臂和腿部）的体表受累程度以及每个区域的脱屑（脱屑）、红斑和斑块硬化/浸润（厚度）的严重程度，得出无银屑病的总体评分为 0，最严重的疾病为 72。
达到 PASI 90 的参与者被定义为与基线相比，PASI 分数至少提高了 90%。
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第 12 周
|
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达到 100% (PASI 100) 改善的参与者人数（Ixekizumab 在患有中度至重度慢性斑块状银屑病的参与者中的疗效。测量：PASI）
大体时间：第 12 周
|
PASI 综合评估了 4 个解剖区域（头部、躯干、手臂和腿部）的体表受累程度以及每个区域的脱屑（脱屑）、红斑和斑块硬化/浸润（厚度）的严重程度，得出无银屑病的总体评分为 0，最严重的疾病为 72。
达到 PASI 100 的参与者被定义为与基线相比，PASI 分数至少提高了 100%。
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第 12 周
|
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达到瘙痒数值评定量表 (NRS) ≥ 4 点减少的参与者人数 [生活质量和结果评估。措施：患者报告的结果（PRO）]
大体时间：第 12 周
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Itch NRS 是参与者管理的单项 11 点水平量表，固定在 0 和 10，0 代表“不痒”，10 代表“可以想象到的最痒”。
参与者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明他们因银屑病引起的瘙痒的总体严重程度。
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第 12 周
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皮肤科生活质量指数 (DLQI) 总分相对于基线的变化
大体时间：基线，第 12 周
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DLQI 是一个简单的、参与者管理的、有 10 个问题、经过验证的生活质量问卷，涵盖 6 个领域：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“完全没有”、“很多”和“非常多”，相应的得分分别为 1、2 和 3，未回答（“不相关”）的回答得分为“0”。
总数范围从 0 到 30（损伤从小到大），与基线相比 5 分的变化被认为具有临床相关性。
使用混合模型重复测量 (MMRM) 计算总 DLQI 得分的最小二乘法 (LS) 平均值，其中基线得分作为协变量，治疗、合并中心、就诊和治疗-就诊相互作用作为固定效应。
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基线，第 12 周
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甲银屑病严重程度指数 (NAPSI) 评分相对于基线的变化
大体时间：基线，第 12 周
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NAPSI 是一种数字的、可重复的、客观的工具，用于根据指甲单元的受累面积评估指甲床银屑病和指甲基质银屑病的严重程度。
指甲被假想的水平线和纵向线分成象限。
每个指甲的指甲床银屑病评分：0（无）至 4（指甲 4 个象限的银屑病）和指甲基质银屑病（0 至 4），具体取决于存在（1 分）或不存在（0 分） ) 每个象限中指甲床和指甲基质银屑病的任何特征。
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）。
对每个指甲进行评估，所有指甲的总和就是总的 NAPSI 分数（范围，0 到 80）。
NAPSI 评分中的 LS 均值使用 MMRM 计算，基线评分作为协变量，治疗、合并中心、就诊和治疗与就诊交互作用作为固定效应。
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基线，第 12 周
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银屑病受累体表面积 (BSA) 百分比
大体时间：第 12 周
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研究者根据从 0%（无参与）到 100%（完全参与）的连续量表评估每位参与者体表面积的牛皮癣受累百分比，其中 1% 对应于参与者手的大小（包括手掌、手指和拇指）。
BSA 中的 LS 均值是使用 MMRM 计算的，其中基线 BSA 作为协变量，治疗、合并中心、访视和治疗与访视交互作用作为固定效应。
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第 12 周
|
|
银屑病头皮严重程度指数 (PSSI) 评分相对于基线的变化
大体时间：基线，第 12 周
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PSSI 是一个综合评分，范围从 0（最好）到 72（最差），由红斑、硬结和脱屑的总分乘以涉及的头皮区域范围的分数得出。
使用 MMRM 计算 PSSI 评分中的 LS 均值，其中基线评分作为协变量，治疗、合并中心、就诊和治疗与就诊交互作用作为固定效应。
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基线，第 12 周
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抑郁症状快速盘点基线的变化-自我报告 16 项 (QIDS-SR16) 总分 [生活质量和结果评估。措施：患者报告的结果（PRO）]
大体时间：基线，第 12 周
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QIDS-SR16 是一种自我管理的 16 项工具，要求参与者考虑每项陈述，因为它与他们过去 7 天的感受方式相关。
每个项目有一个 4 分制，范围从 0（最好）到 3（最差）。
对 16 个项目进行评分，给出 9 个单独的抑郁领域（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[初始、中期和晚期失眠或嗜睡]、食欲/体重减少/增加和精神运动性激越/迟滞），将它们相加得到一个从 0 到 27 不等的分数，分数越高表示症状越严重。
QIDS-SR16 总分的 LS 平均值是使用协方差分析 (ANCOVA) 模型与治疗、合并中心和基线 QIDS 总分计算得出的。
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基线，第 12 周
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工作生产力活动损害问卷-银屑病 (WPAI-PSO) 所有分数相对于基线的变化
大体时间：基线，第 12 周
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WPAI-PSO 是一个包含 6 项的工具，用于评估过去 7 天内银屑病对生产力损害的影响。
它有四个方面：缺勤率、出勤率（工作时生产力下降）、总体工作损害评分和工作以外日常活动的损害。
以百分比形式得出四个分数：旷工率、出勤率、整体工作障碍（旷工率和出勤率）以及工作以外的活动障碍。
百分比的计算方式为：每个分数 * 100，范围为 0 到 100。
分数越高表明生产力受损越大。
每个 WPAI-PSO 分数的 LS 均值是使用 ANCOVA 模型计算的，该模型具有处理、合并中心和基线 WPAI-PSO 分数。
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基线，第 12 周
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医疗结果研究 36 项简表 (SF-36) 健康调查、身体成分总结 (PCS) 和心理成分总结 (MCS) 评分相对于基线的变化
大体时间：基线，第 12 周
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SF-36 是参与者报告的评估参与者健康状况的结果指标。
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 个领域被重新组合为 PCS 和 MCS 分数。
总分范围从 0 到 100，分数越高表示功能水平越好和/或健康状况越好。
在这项研究中，使用了 SF-36 急性版本，它有 1 周的回忆期。
SF-36 评分中的 LS 均值使用具有治疗、合并中心和基线 SF-36 评分的 ANCOVA 模型计算。
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基线，第 12 周
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患者对疾病严重程度的整体评估相对于基线的变化
大体时间：基线，第 12 周
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患者对疾病严重程度的总体评估是一项单项参与者报告的结果测量，参与者被要求对其“今天”的银屑病严重程度进行评分，从 0（无症状）= 无银屑病，到 5（严重）= 最严重曾经有过牛皮癣。
使用 MMRM 计算患者疾病严重程度评分整体评估中的 LS 均值，其中基线评分作为协变量，治疗、合并中心、就诊和治疗与就诊交互作用作为固定效应。
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基线，第 12 周
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实现掌跖 PASI ≥ 50% (PPASI 50) 改善的参与者人数
大体时间：第 12 周
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掌跖 PASI 是一个综合评分，由红斑、硬结和脱屑的总分乘以手掌和足底区域受累程度的评分得出，范围从 0 到 72。
达到 PPASI 50 的参与者被定义为与基线相比，PPASI 分数至少提高了 50%。
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第 12 周
|
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实现掌跖 PASI ≥ 75% (PPASI 75) 改善的参与者人数
大体时间：第 12 周
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掌跖 PASI 是一个综合评分，由红斑、硬结和脱屑的总分乘以手掌和足底区域受累程度的评分得出，范围从 0 到 72。
达到 PPASI 75 的参与者被定义为与基线相比，PPASI 分数至少提高了 75%。
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第 12 周
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实现掌跖 PASI 100% (PPASI 100) 改善的参与者人数
大体时间：第 12 周
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掌跖 PASI 是一个综合评分，由红斑、硬结和脱屑的总分乘以手掌和足底区域受累程度的评分得出，范围从 0 到 72。
达到 PPASI 100 的参与者被定义为与基线相比，PPASI 分数提高了 100%。
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第 12 周
|
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具有治疗紧急抗 Ixekizumab 抗体的参与者人数
大体时间：第 12 周
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按治疗组汇总在基线后任何时间出现治疗中出现阳性抗 ixekizumab 抗体的参与者百分比。
具有治疗中出现阳性抗ixekizumab抗体的参与者百分比计算如下：具有可评估基线样本和≥1个可评估基线后样本的参与者数量/分析人群中的参与者数量* 100。
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第 12 周
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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.
- 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.
- Blauvelt A, Lebwohl MG, Mabuchi T, Leung A, Garrelts A, Crane H, ElMaraghy H, Patel H, Ridenour T, See K, Gallo G, Paul C. Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021 Aug;85(2):360-368. doi: 10.1016/j.jaad.2020.11.022. Epub 2020 Nov 28.
- Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.
- Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.
- Reich K, Jackson K, Ball S, Garces S, Kerr L, Chua L, Muram TM, Blauvelt A. Ixekizumab Pharmacokinetics, Anti-Drug Antibodies, and Efficacy through 60 Weeks of Treatment of Moderate to Severe Plaque Psoriasis. J Invest Dermatol. 2018 Oct;138(10):2168-2173. doi: 10.1016/j.jid.2018.04.019. Epub 2018 May 8.
- Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9. Erratum In: Am J Clin Dermatol. 2018 Mar 29;:
- van de Kerkhof P, Guenther L, Gottlieb AB, Sebastian M, Wu JJ, Foley P, Morita A, Goldblum O, Zhang L, Erickson J, Ball S, Rich P. Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis: results from the randomized, controlled and open-label phases of UNCOVER-3. J Eur Acad Dermatol Venereol. 2017 Mar;31(3):477-482. doi: 10.1111/jdv.14033. Epub 2016 Dec 2.
- Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.
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)
2012年7月28日
初级完成 (实际的)
2014年5月22日
研究完成 (实际的)
2019年7月22日
研究注册日期
首次提交
2012年7月18日
首先提交符合 QC 标准的
2012年7月18日
首次发布 (估计)
2012年7月20日
研究记录更新
最后更新发布 (实际的)
2020年7月28日
上次提交的符合 QC 标准的更新
2020年7月17日
最后验证
2019年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 13685
- I1F-MC-RHBC (其他标识符：Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。
IPD 共享时间框架
在美国和欧盟 (EU) 研究的适应症首次公布和批准（以较晚者为准）后 6 个月可提供数据。
数据将无限期地可供请求。
IPD 共享访问标准
研究计划必须得到独立审查小组的批准，研究人员必须签署数据共享协议。
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
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.