A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
10 de junio de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1257
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 10789
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Darmstadt, Alemania, 64283
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Kiel, Alemania, 24148
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Mahlow, Alemania, 15831
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Munster, Alemania, 48159
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Buenos Aires, Argentina, C1425DKG
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Mendoza, Argentina, 5500
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Benowa, Australia, 4217
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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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Barrie, Canadá, L4M 6L2
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Calgary, Canadá, T2G 1B1
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Halifax, Canadá, B3H1Z2
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Hamilton, Canadá, L8N1V6
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London, Canadá, N6A 3H7
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Markham, Canadá, L3P1X2
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Montreal, Canadá, H2K4L5
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Oakville, Canadá, L6J7W5
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Peterborough, Canadá, K9J 5K2
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Quebec, Canadá, G1V 4X7
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Richmond Hill, Canadá, L4B 1A5
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Sherbrooke, Canadá, J1J 2G2
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Surrey, Canadá, V3V 0C6
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Waterloo, Canadá, N2J 1C4
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Windsor, Canadá, N8W 1E6
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Brno, Chequia, 656 91
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Novy Jicin, Chequia, 741 01
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Plzen-Bory, Chequia, 305-99
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Praha, Chequia, 100 34
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Bucheon, Corea, república de, 420-717
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Pusan, Corea, república de, 602-739
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Seongnam, Corea, república de, 463-707
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Seoul, Corea, república de, 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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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, Estados Unidos, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, Estados Unidos, 90212
- David Stoll, M.D.
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Los Angeles, California, Estados Unidos, 90045
- Dermatology Research Associates
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Sacramento, California, Estados Unidos, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, Estados Unidos, 92108
- Medical Center for Clinical Research
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San Diego, California, Estados Unidos, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, Estados Unidos, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Estados Unidos, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, Estados Unidos, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, Estados Unidos, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, Estados Unidos, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, Estados Unidos, 34471
- Renstar Medical Research
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Ormond Beach, Florida, Estados Unidos, 32174
- Ameriderm Research
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Tampa, Florida, Estados Unidos, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, Estados Unidos, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, Estados Unidos, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, Estados Unidos, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, Estados Unidos, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, Estados Unidos, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, Estados Unidos, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, Estados Unidos, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, Estados Unidos, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, Estados Unidos, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, Estados Unidos, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, Estados Unidos, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, Estados Unidos, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, Estados Unidos, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, Estados Unidos, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Estados Unidos, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Estados Unidos, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, Estados Unidos, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, Estados Unidos, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, Estados Unidos, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, Estados Unidos, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, Estados Unidos, 78705
- Austin Dermatology Associates
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Dallas, Texas, Estados Unidos, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Estados Unidos, 77004
- Center for Clinical Studies
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Houston, Texas, Estados Unidos, 77065
- Center for Clinical Studies
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Pflugerville, Texas, Estados Unidos, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, Estados Unidos, 77598
- Center for Clinical Studies
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Dermatology Associates
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Tacoma, Washington, Estados Unidos, 98405
- MultiCare Health System
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Wenatchee, Washington, Estados Unidos, 98801
- Wenatchee Valley Hospital & Clinics
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Budapest, Hungría, 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, Hungría, 4032
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Oroshaza, Hungría, 5901
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Szolnok, Hungría, 5000
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Osaka, Japón, 545-8586
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Takaoka, Japón, 9330871
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Tsu, Japón, 514-8507
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Mexicali, México, 21100
- 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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Mexico City, México, 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, México, 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, México, CP 58249
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Bialystok, Polonia, 15-351
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Gdansk, Polonia, 80-546
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Kielce, Polonia, 25-316
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Krakow, Polonia, 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, Polonia, 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, Polonia, 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, Polonia, 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, Polonia, 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, Puerto Rico, 00727
- Office of Dr. Samuel Sanchez PSC
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Carolina, Puerto Rico, 00985
- Office of Dr. Alma M. Cruz
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Ponce, Puerto Rico, 00716
- Ponce School of Medicine CAIMED Center
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San Juan, Puerto Rico, 00909
- GCM Medical Group PSC
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San Juan, Puerto Rico, 00918
- Mindful Medical Research
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Bucuresti, Rumania, 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, Rumania, 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, Rumania, 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, Rumania, 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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Tainan, Taiwán, 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, Taiwán, 10048
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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SC administrado
Administered SQ
Otros nombres:
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Experimental: 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.
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SC administrado
Administered SQ
Otros nombres:
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Experimental: 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.
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SC administrado
Administered SQ
Otros nombres:
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Experimental: 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.
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SC administrado
Administered SQ
Otros nombres:
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Experimental: 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.
|
SC administrado
Administered SQ
Otros nombres:
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Experimental: 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.
|
SC administrado
Administered SQ
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Periodo de tiempo: Week 52
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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.
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Week 52
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Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Periodo de tiempo: Week 52
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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.
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Week 52
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Achieving sPGA (0)
Periodo de tiempo: 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.
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Week 52
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Percentage of Participants Achieving PASI 90
Periodo de tiempo: Week 52
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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).
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Week 52
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Percentage of Participants Achieving PASI 100
Periodo de tiempo: Week 52
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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).
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Week 52
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Change From Baseline in PASI
Periodo de tiempo: Baseline, Week 52
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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
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Percent Improvement in PASI
Periodo de tiempo: Baseline, Week 52
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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
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Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
Periodo de tiempo: Baseline, Week 52
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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
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Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Mean Change From Baseline in Palmoplantar PASI (PPASI)
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
Periodo de tiempo: Week 52
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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.
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Week 52
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Change From Baseline in DLQI Total Score
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline in Itch NRS Score
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline in Skin Pain Visual Analog Scale (VAS)
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
Periodo de tiempo: Baseline, Week 52
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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.
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Baseline, Week 52
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Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Periodo de tiempo: Predose, Week 4, 12, 24, 36 and 52 Post dose
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Trough concentrations at steady state of Ixekizumab were evaluated.
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Predose, Week 4, 12, 24, 36 and 52 Post dose
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Number of Participants With Anti-Ixekizumab Antibodies
Periodo de tiempo: Baseline through Week 52
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Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
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Baseline through Week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2015
Finalización primaria (Actual)
1 de noviembre de 2016
Finalización del estudio (Actual)
3 de agosto de 2017
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2015
Publicado por primera vez (Estimar)
31 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2020
Última verificación
1 de junio de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15988
- I1F-MC-RHBP (Otro identificador: Eli Lilly and Company)
- 2015-000190-12 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .