- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02513550
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Przegląd badań
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Buenos Aires, Argentyna, 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, Argentyna, 5500
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Benowa, Australia, 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, Australia, 3053
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Darlinghurst, Australia, 2010
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Fremantle, Australia, 6160
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Phillip, Australia, 02606
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Woolloongabba, Australia, 4102
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Brno, Czechy, 656 91
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Novy Jicin, Czechy, 741 01
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Plzen-Bory, Czechy, 305-99
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Praha, Czechy, 100 34
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Osaka, Japonia, 545-8586
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Takaoka, Japonia, 9330871
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Tsu, Japonia, 514-8507
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Barrie, Kanada, L4M 6L2
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Calgary, Kanada, T2G 1B1
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Halifax, Kanada, B3H1Z2
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Hamilton, Kanada, L8N1V6
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London, Kanada, N6A 3H7
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Markham, Kanada, L3P1X2
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Montreal, Kanada, H2K4L5
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Oakville, Kanada, L6J7W5
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Peterborough, Kanada, K9J 5K2
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Quebec, Kanada, G1V 4X7
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Richmond Hill, Kanada, L4B 1A5
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Sherbrooke, Kanada, J1J 2G2
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Surrey, Kanada, V3V 0C6
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Waterloo, Kanada, N2J 1C4
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Windsor, Kanada, N8W 1E6
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Mexicali, Meksyk, 21100
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Mexico City, Meksyk, 3100
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Monterrey, Meksyk, 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, Meksyk, CP 58249
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Berlin, Niemcy, 10789
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Darmstadt, Niemcy, 64283
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Kiel, Niemcy, 24148
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Mahlow, Niemcy, 15831
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Munster, Niemcy, 48159
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Bialystok, Polska, 15-351
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Gdansk, Polska, 80-546
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Kielce, Polska, 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, Polska, 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, Polska, 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, Polska, 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, Polska, 70-332
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Wroclaw, Polska, 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, Portoryko, 00727
- Office of Dr. Samuel Sanchez PSC
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Carolina, Portoryko, 00985
- Office of Dr. Alma M. Cruz
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Ponce, Portoryko, 00716
- Ponce School of Medicine CAIMED Center
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San Juan, Portoryko, 00909
- GCM Medical Group PSC
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San Juan, Portoryko, 00918
- Mindful Medical Research
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Bucheon, Republika Korei, 420-717
- 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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Pusan, Republika Korei, 602-739
- 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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Seongnam, Republika Korei, 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, Republika Korei, 100799
- 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, Rumunia, 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, Rumunia, 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, Rumunia, 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, Rumunia, 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, Stany Zjednoczone, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, Stany Zjednoczone, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, Stany Zjednoczone, 90212
- David Stoll, M.D.
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Los Angeles, California, Stany Zjednoczone, 90045
- Dermatology Research Associates
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Sacramento, California, Stany Zjednoczone, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, Stany Zjednoczone, 92108
- Medical Center for Clinical Research
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San Diego, California, Stany Zjednoczone, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, Stany Zjednoczone, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, Stany Zjednoczone, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, Stany Zjednoczone, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, Stany Zjednoczone, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, Stany Zjednoczone, 34471
- Renstar Medical Research
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Ormond Beach, Florida, Stany Zjednoczone, 32174
- Ameriderm Research
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Tampa, Florida, Stany Zjednoczone, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, Stany Zjednoczone, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, Stany Zjednoczone, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, Stany Zjednoczone, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, Stany Zjednoczone, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, Stany Zjednoczone, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, Stany Zjednoczone, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, Stany Zjednoczone, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, Stany Zjednoczone, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, Stany Zjednoczone, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, Stany Zjednoczone, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, Stany Zjednoczone, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, Stany Zjednoczone, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, Stany Zjednoczone, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, Stany Zjednoczone, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, Stany Zjednoczone, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, Stany Zjednoczone, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Stany Zjednoczone, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Stany Zjednoczone, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Stany Zjednoczone, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Stany Zjednoczone, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, Stany Zjednoczone, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, Stany Zjednoczone, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, Stany Zjednoczone, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, Stany Zjednoczone, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, Stany Zjednoczone, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, Stany Zjednoczone, 78705
- Austin Dermatology Associates
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Dallas, Texas, Stany Zjednoczone, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Stany Zjednoczone, 77004
- Center For Clinical Studies
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Houston, Texas, Stany Zjednoczone, 77065
- Center For Clinical Studies
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Pflugerville, Texas, Stany Zjednoczone, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, Stany Zjednoczone, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, Stany Zjednoczone, 77598
- Center For Clinical Studies
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, Stany Zjednoczone, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, Stany Zjednoczone, 98101
- Dermatology Associates
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Tacoma, Washington, Stany Zjednoczone, 98405
- MultiCare Health System
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Wenatchee, Washington, Stany Zjednoczone, 98801
- Wenatchee Valley Hospital & Clinics
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Tainan, Tajwan, 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, Tajwan, 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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Budapest, Węgry, 1238
- 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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Debrecen, Węgry, 4032
- 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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Oroshaza, Węgry, 5901
- 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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Szolnok, Węgry, 5000
- 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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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
Administrowany SQ
Administered SQ
Inne nazwy:
|
|
Eksperymentalny: 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.
|
Administrowany SQ
Administered SQ
Inne nazwy:
|
|
Eksperymentalny: 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.
|
Administrowany SQ
Administered SQ
Inne nazwy:
|
|
Eksperymentalny: 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.
|
Administrowany SQ
Administered SQ
Inne nazwy:
|
|
Eksperymentalny: 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.
|
Administrowany SQ
Administered SQ
Inne nazwy:
|
|
Eksperymentalny: 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.
|
Administrowany SQ
Administered SQ
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants Achieving sPGA (0)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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])
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline through Week 52
|
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
|
Baseline through Week 52
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 15988
- I1F-MC-RHBP (Inny identyfikator: Eli Lilly and Company)
- 2015-000190-12 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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