A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
10 juin 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
1257
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 10789
- 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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Darmstadt, Allemagne, 64283
- 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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Kiel, Allemagne, 24148
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Mahlow, Allemagne, 15831
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Munster, Allemagne, 48159
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Buenos Aires, Argentine, C1425DKG
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Mendoza, Argentine, 5500
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Benowa, Australie, 4217
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Carlton, Australie, 3053
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Darlinghurst, Australie, 2010
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Fremantle, Australie, 6160
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Phillip, Australie, 02606
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Woolloongabba, Australie, 4102
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Barrie, Canada, L4M 6L2
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Calgary, Canada, T2G 1B1
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Halifax, Canada, B3H1Z2
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Hamilton, Canada, L8N1V6
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London, Canada, N6A 3H7
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Markham, Canada, L3P1X2
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Montreal, Canada, H2K4L5
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Oakville, Canada, L6J7W5
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Peterborough, Canada, K9J 5K2
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Quebec, Canada, G1V 4X7
- 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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Richmond Hill, Canada, L4B 1A5
- 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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Sherbrooke, Canada, J1J 2G2
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Surrey, Canada, V3V 0C6
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Waterloo, Canada, N2J 1C4
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Windsor, Canada, N8W 1E6
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Bucheon, Corée, République de, 420-717
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Pusan, Corée, République de, 602-739
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Seongnam, Corée, République de, 463-707
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Seoul, Corée, République de, 100799
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Budapest, Hongrie, 1238
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Debrecen, Hongrie, 4032
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Oroshaza, Hongrie, 5901
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Szolnok, Hongrie, 5000
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Osaka, Japon, 545-8586
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Takaoka, Japon, 9330871
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Tsu, Japon, 514-8507
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Mexicali, Mexique, 21100
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Mexico City, Mexique, 3100
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Monterrey, Mexique, 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, Mexique, CP 58249
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Bialystok, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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, Porto Rico, 00727
- Office of Dr. Samuel Sanchez PSC
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Carolina, Porto Rico, 00985
- Office of Dr. Alma M. Cruz
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Ponce, Porto Rico, 00716
- Ponce School of Medicine CAIMED Center
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San Juan, Porto Rico, 00909
- GCM Medical Group PSC
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San Juan, Porto Rico, 00918
- Mindful Medical Research
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Bucuresti, Roumanie, 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, Roumanie, 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, Roumanie, 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, Roumanie, 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, Taïwan, 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, Taïwan, 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, Tchéquie, 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, Tchéquie, 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, Tchéquie, 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, Tchéquie, 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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Alabama
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Birmingham, Alabama, États-Unis, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, États-Unis, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, États-Unis, 90212
- David Stoll, M.D.
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Los Angeles, California, États-Unis, 90045
- Dermatology Research Associates
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Sacramento, California, États-Unis, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, États-Unis, 92108
- Medical Center for Clinical Research
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San Diego, California, États-Unis, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, États-Unis, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, États-Unis, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, États-Unis, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, États-Unis, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, États-Unis, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, États-Unis, 34471
- Renstar Medical Research
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Ormond Beach, Florida, États-Unis, 32174
- Ameriderm Research
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Tampa, Florida, États-Unis, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, États-Unis, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, États-Unis, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, États-Unis, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, États-Unis, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, États-Unis, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, États-Unis, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, États-Unis, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, États-Unis, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, États-Unis, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, États-Unis, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, États-Unis, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, États-Unis, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, États-Unis, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, États-Unis, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, États-Unis, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, États-Unis, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, États-Unis, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, États-Unis, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, États-Unis, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, États-Unis, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, États-Unis, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, États-Unis, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, États-Unis, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, États-Unis, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, États-Unis, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, États-Unis, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, États-Unis, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, États-Unis, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, États-Unis, 78705
- Austin Dermatology Associates
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Dallas, Texas, États-Unis, 75246
- Menter Dermatology Research Institute
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Houston, Texas, États-Unis, 77004
- Center for Clinical Studies
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Houston, Texas, États-Unis, 77065
- Center for Clinical Studies
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Pflugerville, Texas, États-Unis, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, États-Unis, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, États-Unis, 77598
- Center for Clinical Studies
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, États-Unis, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, États-Unis, 98101
- Dermatology Associates
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Tacoma, Washington, États-Unis, 98405
- MultiCare Health System
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Wenatchee, Washington, États-Unis, 98801
- Wenatchee Valley Hospital & Clinics
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
SQ administré
Administered SQ
Autres noms:
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|
Expérimental: 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.
|
SQ administré
Administered SQ
Autres noms:
|
|
Expérimental: 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.
|
SQ administré
Administered SQ
Autres noms:
|
|
Expérimental: 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.
|
SQ administré
Administered SQ
Autres noms:
|
|
Expérimental: 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.
|
SQ administré
Administered SQ
Autres noms:
|
|
Expérimental: 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.
|
SQ administré
Administered SQ
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Achieving sPGA (0)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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])
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline through Week 52
|
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
|
Baseline through Week 52
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2015
Achèvement primaire (Réel)
1 novembre 2016
Achèvement de l'étude (Réel)
3 août 2017
Dates d'inscription aux études
Première soumission
30 juillet 2015
Première soumission répondant aux critères de contrôle qualité
30 juillet 2015
Première publication (Estimation)
31 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juin 2020
Dernière vérification
1 juin 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15988
- I1F-MC-RHBP (Autre identifiant: Eli Lilly and Company)
- 2015-000190-12 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .