A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
10 июня 2020 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
1257
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Benowa, Австралия, 4217
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Carlton, Австралия, 3053
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Darlinghurst, Австралия, 2010
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Fremantle, Австралия, 6160
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Phillip, Австралия, 02606
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Woolloongabba, Австралия, 4102
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Buenos Aires, Аргентина, C1425DKG
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Mendoza, Аргентина, 5500
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Budapest, Венгрия, 1238
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Debrecen, Венгрия, 4032
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Oroshaza, Венгрия, 5901
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Szolnok, Венгрия, 5000
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Berlin, Германия, 10789
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Darmstadt, Германия, 64283
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Kiel, Германия, 24148
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Mahlow, Германия, 15831
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Munster, Германия, 48159
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Barrie, Канада, L4M 6L2
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Calgary, Канада, T2G 1B1
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Halifax, Канада, B3H1Z2
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Hamilton, Канада, L8N1V6
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London, Канада, N6A 3H7
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Markham, Канада, L3P1X2
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Montreal, Канада, H2K4L5
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Oakville, Канада, L6J7W5
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Peterborough, Канада, K9J 5K2
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Quebec, Канада, G1V 4X7
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Richmond Hill, Канада, L4B 1A5
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Sherbrooke, Канада, J1J 2G2
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Surrey, Канада, V3V 0C6
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Waterloo, Канада, N2J 1C4
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Windsor, Канада, N8W 1E6
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Bucheon, Корея, Республика, 420-717
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Pusan, Корея, Республика, 602-739
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Seongnam, Корея, Республика, 463-707
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Seoul, Корея, Республика, 100799
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Mexicali, Мексика, 21100
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Mexico City, Мексика, 3100
- 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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Monterrey, Мексика, 64060
- 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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Morelia, Мексика, CP 58249
- 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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Bialystok, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Пуэрто-Рико, 00727
- Office of Dr. Samuel Sanchez PSC
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Carolina, Пуэрто-Рико, 00985
- Office of Dr. Alma M. Cruz
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Ponce, Пуэрто-Рико, 00716
- Ponce School of Medicine CAIMED Center
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San Juan, Пуэрто-Рико, 00909
- GCM Medical Group PSC
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San Juan, Пуэрто-Рико, 00918
- Mindful Medical Research
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Bucuresti, Румыния, 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, Румыния, 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, Румыния, 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, Румыния, 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, Соединенные Штаты, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, Соединенные Штаты, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, Соединенные Штаты, 90212
- David Stoll, M.D.
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Los Angeles, California, Соединенные Штаты, 90045
- Dermatology Research Associates
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Sacramento, California, Соединенные Штаты, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, Соединенные Штаты, 92108
- Medical Center for Clinical Research
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San Diego, California, Соединенные Штаты, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, Соединенные Штаты, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Соединенные Штаты, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, Соединенные Штаты, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, Соединенные Штаты, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, Соединенные Штаты, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, Соединенные Штаты, 34471
- Renstar Medical Research
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Ormond Beach, Florida, Соединенные Штаты, 32174
- Ameriderm Research
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Tampa, Florida, Соединенные Штаты, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, Соединенные Штаты, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, Соединенные Штаты, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, Соединенные Штаты, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, Соединенные Штаты, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, Соединенные Штаты, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, Соединенные Штаты, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, Соединенные Штаты, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, Соединенные Штаты, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, Соединенные Штаты, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, Соединенные Штаты, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, Соединенные Штаты, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, Соединенные Штаты, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, Соединенные Штаты, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, Соединенные Штаты, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, Соединенные Штаты, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Соединенные Штаты, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, Соединенные Штаты, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Соединенные Штаты, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Соединенные Штаты, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, Соединенные Штаты, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, Соединенные Штаты, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, Соединенные Штаты, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, Соединенные Штаты, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, Соединенные Штаты, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, Соединенные Штаты, 78705
- Austin Dermatology Associates
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Dallas, Texas, Соединенные Штаты, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Соединенные Штаты, 77004
- Center for Clinical Studies
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Houston, Texas, Соединенные Штаты, 77065
- Center for Clinical Studies
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Pflugerville, Texas, Соединенные Штаты, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, Соединенные Штаты, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, Соединенные Штаты, 77598
- Center for Clinical Studies
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, Соединенные Штаты, 98101
- Dermatology Associates
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Tacoma, Washington, Соединенные Штаты, 98405
- MultiCare Health System
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Wenatchee, Washington, Соединенные Штаты, 98801
- Wenatchee Valley Hospital & Clinics
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Tainan, Тайвань, 70166
- 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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Taipei, Тайвань, 10048
- 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, Чехия, 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, Чехия, 741 01
- 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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Plzen-Bory, Чехия, 305-99
- 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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Praha, Чехия, 100 34
- 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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Osaka, Япония, 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, Япония, 9330871
- 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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Tsu, Япония, 514-8507
- 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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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Администрируемый SQ
Administered SQ
Другие имена:
|
|
Экспериментальный: 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.
|
Администрируемый SQ
Administered SQ
Другие имена:
|
|
Экспериментальный: 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.
|
Администрируемый SQ
Administered SQ
Другие имена:
|
|
Экспериментальный: 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.
|
Администрируемый SQ
Administered SQ
Другие имена:
|
|
Экспериментальный: 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.
|
Администрируемый SQ
Administered SQ
Другие имена:
|
|
Экспериментальный: 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.
|
Администрируемый SQ
Administered SQ
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Временное ограничение: 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)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants Achieving sPGA (0)
Временное ограничение: 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
|
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Percentage of Participants Achieving PASI 90
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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])
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
|
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Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Временное ограничение: 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
|
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Number of Participants With Anti-Ixekizumab Antibodies
Временное ограничение: Baseline through Week 52
|
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
|
Baseline through Week 52
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 августа 2015 г.
Первичное завершение (Действительный)
1 ноября 2016 г.
Завершение исследования (Действительный)
3 августа 2017 г.
Даты регистрации исследования
Первый отправленный
30 июля 2015 г.
Впервые представлено, что соответствует критериям контроля качества
30 июля 2015 г.
Первый опубликованный (Оценивать)
31 июля 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 июня 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 июня 2020 г.
Последняя проверка
1 июня 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 15988
- I1F-MC-RHBP (Другой идентификатор: Eli Lilly and Company)
- 2015-000190-12 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .