A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
2020年6月10日 更新者：Eli Lilly and Company
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.
研究概览
详细说明
The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens.
There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.
研究类型
介入性
注册 (实际的)
1257
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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Barrie、加拿大、L4M 6L2
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Calgary、加拿大、T2G 1B1
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Halifax、加拿大、B3H1Z2
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Hamilton、加拿大、L8N1V6
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London、加拿大、N6A 3H7
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Markham、加拿大、L3P1X2
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Montreal、加拿大、H2K4L5
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Oakville、加拿大、L6J7W5
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Peterborough、加拿大、K9J 5K2
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Quebec、加拿大、G1V 4X7
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Richmond Hill、加拿大、L4B 1A5
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Sherbrooke、加拿大、J1J 2G2
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Surrey、加拿大、V3V 0C6
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Waterloo、加拿大、N2J 1C4
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Windsor、加拿大、N8W 1E6
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Budapest、匈牙利、1238
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Debrecen、匈牙利、4032
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Oroshaza、匈牙利、5901
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Szolnok、匈牙利、5000
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Tainan、台湾、70166
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Taipei、台湾、10048
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Mexicali、墨西哥、21100
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Mexico City、墨西哥、3100
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Monterrey、墨西哥、64060
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Morelia、墨西哥、CP 58249
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Bucheon、大韩民国、420-717
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Pusan、大韩民国、602-739
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Seongnam、大韩民国、463-707
- 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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Seoul、大韩民国、100799
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Berlin、德国、10789
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Darmstadt、德国、64283
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Kiel、德国、24148
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Mahlow、德国、15831
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Munster、德国、48159
- 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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Brno、捷克语、656 91
- 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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Novy Jicin、捷克语、741 01
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Plzen-Bory、捷克语、305-99
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Praha、捷克语、100 34
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Osaka、日本、545-8586
- 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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Takaoka、日本、9330871
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Tsu、日本、514-8507
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Bialystok、波兰、15-351
- 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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Gdansk、波兰、80-546
- 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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Kielce、波兰、25-316
- 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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Krakow、波兰、30-438
- 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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Lodz、波兰、90-265
- 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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Swidnik、波兰、21-040
- 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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Szczecin、波兰、70-332
- 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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Wroclaw、波兰、51-318
- 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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Caguas、波多黎各、00727
- Office of Dr. Samuel Sanchez PSC
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Carolina、波多黎各、00985
- Office of Dr. Alma M. Cruz
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Ponce、波多黎各、00716
- Ponce School of Medicine CAIMED Center
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San Juan、波多黎各、00909
- GCM Medical Group PSC
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San Juan、波多黎各、00918
- Mindful Medical Research
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Benowa、澳大利亚、4217
- 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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Carlton、澳大利亚、3053
- 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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Darlinghurst、澳大利亚、2010
- 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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Fremantle、澳大利亚、6160
- 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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Phillip、澳大利亚、02606
- 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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Woolloongabba、澳大利亚、4102
- 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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Bucuresti、罗马尼亚、011025
- 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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Cluj Napoca、罗马尼亚、400006
- 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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Constanta、罗马尼亚、900125
- 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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Craiova、罗马尼亚、200642
- 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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Alabama
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Birmingham、Alabama、美国、35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim、California、美国、92801
- Anaheim Clinical Trials, LLC
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Beverly Hills、California、美国、90212
- David Stoll, M.D.
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Los Angeles、California、美国、90045
- Dermatology Research Associates
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Sacramento、California、美国、95819
- Center for Dermatology and Laser Surgery
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San Diego、California、美国、92108
- Medical Center for Clinical Research
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San Diego、California、美国、92123
- University Clinical Trials, Inc.
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Santa Monica、California、美国、90404
- Clinical Science Institute
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Colorado
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Denver、Colorado、美国、80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables、Florida、美国、33134
- Florida Academic Dermatology Centers
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DeLand、Florida、美国、32720
- Avail Clinical Research LLC
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Jacksonville、Florida、美国、32216
- Jacksonville Center for Clinical Research
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Ocala、Florida、美国、34471
- Renstar Medical Research
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Ormond Beach、Florida、美国、32174
- Ameriderm Research
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Tampa、Florida、美国、33624
- University of South Florida
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Georgia
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Atlanta、Georgia、美国、30342
- Advanced Medical Research
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Illinois
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Darien、Illinois、美国、60561
- University Dermatology
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Indiana
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Evansville、Indiana、美国、47714
- Deaconess Clinic Inc
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Indianapolis、Indiana、美国、46256
- Dawes Fretzin Clinical Research
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South Bend、Indiana、美国、46617
- The South Bend Clinic
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Kansas
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Overland Park、Kansas、美国、66215
- Kansas City Dermatology, PA
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Wichita、Kansas、美国、67207
- Heartland Research Associates
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Kentucky
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Louisville、Kentucky、美国、40202
- Dermatology Specialist
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Louisiana
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Lake Charles、Louisiana、美国、70605
- Dr. Shondra Smith MD
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Maryland
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Rockville、Maryland、美国、20850
- DermAssociates, P.C.
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Massachusetts
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Beverly、Massachusetts、美国、01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis、Missouri、美国、63117
- Central Dermatology PC
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New Hampshire
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Newington、New Hampshire、美国、03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor、New Jersey、美国、08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque、New Mexico、美国、87106-5239
- Academic Dermatology Associates
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New York
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New York、New York、美国、10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester、New York、美国、14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill、North Carolina、美国、27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington、North Carolina、美国、28401
- PMG Research of Wilmington, LLC
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Wilmington、North Carolina、美国、28405
- Wilmington Dermatology Center
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Winston-Salem、North Carolina、美国、27103
- Piedmont Medical Research
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Ohio
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Cleveland、Ohio、美国、44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa、Oklahoma、美国、74135
- Healthcare Research Consultant
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Oregon
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Portland、Oregon、美国、97210
- Oregon Dermatology and Research Center
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Portland、Oregon、美国、97223
- Oregon Medical Research Center
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Pennsylvania
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Exton、Pennsylvania、美国、19341
- Dermatology and Skin Surgery Center
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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Wyomissing、Pennsylvania、美国、19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley、Pennsylvania、美国、19067
- Yardley Dermatology
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Rhode Island
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Johnston、Rhode Island、美国、02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant、South Carolina、美国、29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville、Tennessee、美国、37922
- The Skin Wellness Center PC
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Texas
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Austin、Texas、美国、78705
- Austin Dermatology Associates
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Dallas、Texas、美国、75246
- Menter Dermatology Research Institute
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Houston、Texas、美国、77004
- Center for Clinical Studies
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Houston、Texas、美国、77065
- Center for Clinical Studies
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Pflugerville、Texas、美国、78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio、Texas、美国、78229
- Clinical Trials of Texas, Inc.
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Webster、Texas、美国、77598
- Center for Clinical Studies
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah Medical Center
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Virginia
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Norfolk、Virginia、美国、23507
- Virginia Clinical Research
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Washington
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Seattle、Washington、美国、98101
- Dermatology Associates
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Tacoma、Washington、美国、98405
- MultiCare Health System
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Wenatchee、Washington、美国、98801
- Wenatchee Valley Hospital & Clinics
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Buenos Aires、阿根廷、C1425DKG
- 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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Mendoza、阿根廷、5500
- 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
Inclusion Criteria:
- Present with chronic plaque psoriasis for at least 6 months prior to enrollment
- At least 10% BSA of psoriasis at screening and at enrollment
- sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
- Candidates for phototherapy and/or systemic therapy
- Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment
Exclusion Criteria:
- Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
- History of drug-induced psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
- Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
- Concurrent or recent use of any biologic agent
- Have participated in any study with ixekizumab
- Received a live vaccination within 12 weeks prior to enrollment
- Serious disorder or illness other than psoriasis
- Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
- Major surgery within 8 weeks of baseline, or will require surgery during the study
- Breastfeeding or nursing (lactating) women
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：80 mg Ixekizumab Q2W
160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
管理SQ
Administered SQ
其他名称：
|
|
实验性的：80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
管理SQ
Administered SQ
其他名称：
|
|
实验性的：80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
管理SQ
Administered SQ
其他名称：
|
|
实验性的：80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
管理SQ
Administered SQ
其他名称：
|
|
实验性的：80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
管理SQ
Administered SQ
其他名称：
|
|
实验性的：80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
管理SQ
Administered SQ
其他名称：
|
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 |
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
大体时间：Week 52
|
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Week 52
|
|
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
大体时间：Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
|
Week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants Achieving sPGA (0)
大体时间：Week 52
|
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Week 52
|
|
Percentage of Participants Achieving PASI 90
大体时间：Week 52
|
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
|
Week 52
|
|
Percentage of Participants Achieving PASI 100
大体时间：Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
|
Week 52
|
|
Change From Baseline in PASI
大体时间：Baseline, Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. |
Baseline, Week 52
|
|
Percent Improvement in PASI
大体时间：Baseline, Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. |
Baseline, Week 52
|
|
Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
大体时间：Baseline, Week 52
|
The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. |
Baseline, Week 52
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
大体时间：Baseline, Week 52
|
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps.
This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit.
The fn is divided with imaginary horizontal and longitudinal lines into quadrants.
Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant.
The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8).
Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps).
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
大体时间：Baseline, Week 52
|
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe).
The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Mean Change From Baseline in Palmoplantar PASI (PPASI)
大体时间：Baseline, Week 52
|
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI).
The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
大体时间：Baseline, Week 52
|
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable."
Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Baseline, Week 52
|
|
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
大体时间：Week 52
|
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0."
Totals range from 0 to 30 (less to more impairment).
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Week 52
|
|
Change From Baseline in DLQI Total Score
大体时间：Baseline, Week 52
|
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0."
Totals range from 0 to 30 (less to more impairment).
LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Change From Baseline in Itch NRS Score
大体时间：Baseline, Week 52
|
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable."
Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Change From Baseline in Skin Pain Visual Analog Scale (VAS)
大体时间：Baseline, Week 52
|
The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS.
Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain).
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
大体时间：Baseline, Week 52
|
EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal.
The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain).
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
大体时间：Predose, Week 4, 12, 24, 36 and 52 Post dose
|
Trough concentrations at steady state of Ixekizumab were evaluated.
|
Predose, Week 4, 12, 24, 36 and 52 Post dose
|
|
Number of Participants With Anti-Ixekizumab Antibodies
大体时间：Baseline through Week 52
|
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
|
Baseline through Week 52
|
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。
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
2015年8月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2017年8月3日
研究注册日期
首次提交
2015年7月30日
首先提交符合 QC 标准的
2015年7月30日
首次发布 (估计)
2015年7月31日
研究记录更新
最后更新发布 (实际的)
2020年6月17日
上次提交的符合 QC 标准的更新
2020年6月10日
最后验证
2020年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 15988
- I1F-MC-RHBP (其他标识符：Eli Lilly and Company)
- 2015-000190-12 (EudraCT编号)
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
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共享时间框架
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.