A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
10. juni 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
1257
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, 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
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Richmond Hill, Canada, L4B 1A5
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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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Alabama
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Birmingham, Alabama, Forente stater, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, Forente stater, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, Forente stater, 90212
- David Stoll, M.D.
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Los Angeles, California, Forente stater, 90045
- Dermatology Research Associates
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Sacramento, California, Forente stater, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, Forente stater, 92108
- Medical Center for Clinical Research
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San Diego, California, Forente stater, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, Forente stater, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Forente stater, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, Forente stater, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, Forente stater, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, Forente stater, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, Forente stater, 34471
- Renstar Medical Research
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Ormond Beach, Florida, Forente stater, 32174
- Ameriderm Research
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Tampa, Florida, Forente stater, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, Forente stater, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, Forente stater, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, Forente stater, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, Forente stater, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, Forente stater, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, Forente stater, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, Forente stater, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, Forente stater, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, Forente stater, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, Forente stater, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, Forente stater, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, Forente stater, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, Forente stater, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, Forente stater, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, Forente stater, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, Forente stater, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Forente stater, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Forente stater, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, Forente stater, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Forente stater, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Forente stater, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, Forente stater, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, Forente stater, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, Forente stater, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, Forente stater, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, Forente stater, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, Forente stater, 78705
- Austin Dermatology Associates
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Dallas, Texas, Forente stater, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Forente stater, 77004
- Center for Clinical Studies
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Houston, Texas, Forente stater, 77065
- Center for Clinical Studies
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Pflugerville, Texas, Forente stater, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, Forente stater, 77598
- Center for Clinical Studies
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, Forente stater, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, Forente stater, 98101
- Dermatology Associates
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Tacoma, Washington, Forente stater, 98405
- MultiCare Health System
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Wenatchee, Washington, Forente stater, 98801
- Wenatchee Valley Hospital & Clinics
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Osaka, Japan, 545-8586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Takaoka, Japan, 9330871
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tsu, Japan, 514-8507
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucheon, Korea, Republikken, 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, Korea, Republikken, 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, Korea, Republikken, 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, Korea, Republikken, 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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Mexicali, Mexico, 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, Mexico, 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, Mexico, 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, Mexico, CP 58249
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Bialystok, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Romania, 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, Romania, 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, Romania, 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, Romania, 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, Taiwan, 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, Taiwan, 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, Tsjekkia, 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, Tsjekkia, 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, Tsjekkia, 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, Tsjekkia, 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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Berlin, Tyskland, 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, Tyskland, 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, Tyskland, 24148
- 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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Mahlow, Tyskland, 15831
- 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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Munster, Tyskland, 48159
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Budapest, Ungarn, 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, Ungarn, 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, Ungarn, 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, Ungarn, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Administrert SQ
Administered SQ
Andre navn:
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Eksperimentell: 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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Administrert SQ
Administered SQ
Andre navn:
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Eksperimentell: 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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Administrert SQ
Administered SQ
Andre navn:
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Eksperimentell: 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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Administrert SQ
Administered SQ
Andre navn:
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Eksperimentell: 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.
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Administrert SQ
Administered SQ
Andre navn:
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Eksperimentell: 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.
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Administrert SQ
Administered SQ
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Achieving sPGA (0)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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])
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2015
Primær fullføring (Faktiske)
1. november 2016
Studiet fullført (Faktiske)
3. august 2017
Datoer for studieregistrering
Først innsendt
30. juli 2015
Først innsendt som oppfylte QC-kriteriene
30. juli 2015
Først lagt ut (Anslag)
31. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15988
- I1F-MC-RHBP (Annen identifikator: Eli Lilly and Company)
- 2015-000190-12 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .