A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2) (UNCOVER-2)
9. června 2020 aktualizováno: Eli Lilly and Company
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1224
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Australian Capital Territory
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Phillip, Australian Capital Territory, Austrálie, 02606
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New South Wales
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St. Leonards, New South Wales, Austrálie, 2065
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Sydney, New South Wales, Austrálie, 02000
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Queensland
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Woolloogabba, Queensland, Austrálie, 4120
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South Australia
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Hectorville, South Australia, Austrálie, 05073
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Victoria
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Box Hill, Victoria, Austrálie, 3128
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Carlton, Victoria, Austrálie, 3053
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Amiens, Francie, 80054
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Besancon, Francie, 25030
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Boulogne, Francie, 92104
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Cannes, Francie, 06400
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Chambray Les Tours, Francie, 37170
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Marseille, Francie, 13385
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Nice, Francie, 06202
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Paris, Francie, 75475
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Poitiers, Francie, 86021
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Rouen, Francie, 76036
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Toulouse, Francie, 31059
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Breda, Holandsko, 4818 CK
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Nijmegen, Holandsko, 6525 GA
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Rotterdam, Holandsko
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Alberta
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Calgary, Alberta, Kanada, T3G 0B4
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Edmonton, Alberta, Kanada, T5K 1X3
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British Columbia
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Surrey, British Columbia, Kanada, V3R 6A7
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Ontario
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Barrie, Ontario, Kanada, L4M6L2
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Hamilton, Ontario, Kanada, L8N1V6
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London, Ontario, Kanada, N6A 3H7
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Markham, Ontario, Kanada, L3P1A8
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North Bay, Ontario, Kanada, P1B 3Z7
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Peterborough, Ontario, Kanada, K9J 1Z2
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Toronto, Ontario, Kanada, M5S 3B4
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Quebec
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Sainte-Foy, Quebec, Kanada, G1V 3T6
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Sherbrooke, Quebec, Kanada, J1J 2G2
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Berlin, Německo, 14197
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Darmstadt, Německo, 64283
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Dresden, Německo, 01307
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Essen, Německo, 45122
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Giessen, Německo, 35390
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Göttingen, Německo, 37075
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Hamburg, Německo, 22143
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Hannover, Německo, 30449
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Jena, Německo, 07740
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Osnabrück, Německo, 49078
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Tübingen, Německo, 72076
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Witten, Německo, 58453
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Gdansk, Polsko, 80-952
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Kielce, Polsko, 25-317
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Lodz, Polsko, 90-265
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Lublin, Polsko, 20-081
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Opole, Polsko, 48-080
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Szczecin, Polsko, 70-111
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Warsaw, Polsko, 02-507
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Feldkirch, Rakousko, 6807
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Graz, Rakousko, 8036
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Innsbruck, Rakousko, 6020
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Vienna, Rakousko, A1090
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Bucharest, Rumunsko, 020125
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Craiova, Rumunsko, 200642
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Iasi, Rumunsko, 700381
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Timisoara, Rumunsko, 300077
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Lanarkshire, Spojené království, ML6 0JS
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Salford, Spojené království, M6 8HD
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Scunthorpe, Spojené království, DN15 7BA
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Sheffield, Spojené království, S10 2JF
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Angus
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Dundee, Angus, Spojené království, DD1 9SY
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Hampstead
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London, Hampstead, Spojené království, NW3 2QG
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Scotland
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Glasgow, Scotland, Spojené království, G11 6NT
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Arizona
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Phoenix, Arizona, Spojené státy, 85032
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Scottsdale, Arizona, Spojené státy, 85254
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72204
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California
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Riverside, California, Spojené státy, 92505
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San Diego, California, Spojené státy, 92123
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Colorado
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Denver, Colorado, Spojené státy, 80220
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Connecticut
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Farmington, Connecticut, Spojené státy, 06030
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20037
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Florida
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Boca Raton, Florida, Spojené státy, 33431
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DeLand, Florida, Spojené státy, 32720
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Jacksonville, Florida, Spojené státy, 32204
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Tampa, Florida, Spojené státy, 33612
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West Palm Beach, Florida, Spojené státy, 33409
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Georgia
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Alpharetta, Georgia, Spojené státy, 30022
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Atlanta, Georgia, Spojené státy, 30327
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Indiana
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Plainfield, Indiana, Spojené státy, 46168
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Kansas
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Overland Park, Kansas, Spojené státy, 66215
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70809
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Maryland
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Silver Spring, Maryland, Spojené státy, 20902
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Massachusetts
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Andover, Massachusetts, Spojené státy, 01810
- 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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Worcester, Massachusetts, Spojené státy, 01605
- 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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Missouri
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Saint Louis, Missouri, Spojené státy, 63117
- 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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New Jersey
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Paramus, New Jersey, Spojené státy, 07652
- 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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Verona, New Jersey, Spojené státy, 07044
- 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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New York
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New York, New York, Spojené státy, 10029
- 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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North Carolina
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Wilmington, North Carolina, Spojené státy, 28403
- 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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Oklahoma
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Norman, Oklahoma, Spojené státy, 73071
- 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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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19103
- 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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Pittsburgh, Pennsylvania, Spojené státy, 15213
- 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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South Carolina
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Greer, South Carolina, Spojené státy, 29650
- 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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Tennessee
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Bristol, Tennessee, Spojené státy, 37620
- 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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Knoxville, Tennessee, Spojené státy, 37922
- 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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Texas
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Arlington, Texas, Spojené státy, 76011
- 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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Austin, Texas, Spojené státy, 78705
- 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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Dallas, Texas, Spojené státy, 75230
- 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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San Antonio, Texas, Spojené státy, 78229
- 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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Webster, Texas, Spojené státy, 77598
- 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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Utah
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Salt Lake City, Utah, Spojené státy, 84132
- 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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Virginia
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Norfolk, Virginia, Spojené státy, 23507
- 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, Virginia, Spojené státy, 23294
- 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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Washington
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Spokane, Washington, Spojené státy, 99204
- 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, Česko, 602 00
- 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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Prague, Česko, 150 06
- 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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-
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Alcorcón, Španělsko, 28922
- 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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Alicante, Španělsko, 03010
- 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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Badalona, Španělsko, 08916
- 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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Barcelona, Španělsko, 08025
- 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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Las Palmas, Španělsko, 35010
- 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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Madrid, Španělsko, 28041
- 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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Málaga, Španělsko, 29010
- 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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Sevilla, Španělsko, 41071
- 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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
- At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
- Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
- Candidate for phototherapy and/or systemic therapy
- Men must agree to use a reliable method of birth control or remain abstinent during the study
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria:
- Pustular, erythrodermic, and/or guttate forms of psoriasis
- History of drug-induced psoriasis
- Prior use of etanercept
- Clinically significant flare of psoriasis during the 12 weeks prior to randomization
- Concurrent or recent use of any biologic agent
- Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
- Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- Serious disorder or illness other than plaque psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 80 mg ixekizumab Dosing Regimen 1
Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12.
At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.
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Administered SC
Ostatní jména:
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Experimentální: 80 mg ixekizumab Dosing Regimen 2
Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 12.
At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.
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Administered SC
Ostatní jména:
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Experimentální: 80 mg ixekizumab Dosing Regimen 3
Dosing Regimen 3 is not used until Week 12.
At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.
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Administered SC
Ostatní jména:
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Aktivní komparátor: 50 mg etanercept
Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12.
At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2.
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Spravováno SC
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Komparátor placeba: Placebo for ixekizumab
Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12.
At Week 12, placebo responders are assigned to placebo, and nonresponders to Dosing Regimen 2. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12 was used to blind etanercept injections for Dosing Regimen 1, Dosing Regimen 2, and Placebo Comparator groups.
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Spravováno SC
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
Časové okno: Week 12
|
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.
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Week 12
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Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Časové okno: Week 12
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs).
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 achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
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Week 12
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])
Časové okno: Week 12
|
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).
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Week 12
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Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])
Časové okno: Week 12
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs).
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 by itself and the scores were 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 achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.
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Week 12
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Percentage of Participants Achieving PASI 100% (PASI100)
Časové okno: Week 12
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs).
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 by itself and the scores were 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 achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.
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Week 12
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Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60
Časové okno: Week 60
|
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).
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Week 60
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Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline
Časové okno: Week 12
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The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable".
The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4.
Describes worst level of itching in past 24 hours.
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Week 12
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Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])
Časové okno: Baseline, Week 12
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DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much); and "not relevant" and unanswered responses were scored as "0."
Total scores range from 0 to 30, with higher score indicating greater quality of life impairment.
A 5-point change from baseline is considered clinically relevant.
Least Squares (LS) Mean change from baseline was calculated using mixed model repeated measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
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Baseline, Week 12
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Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Časové okno: Baseline, Week 12
|
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps.
The fingernail bed and fingernail matrix are each divided into quadrants.
Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix.
The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8).
The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps.
LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
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Baseline, Week 12
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Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score
Časové okno: Baseline, Week 12
|
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 scores range from 0 (less severity) to 72 (more severity), with lower scores indicating less severity.
LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.
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Baseline, Week 12
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Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis
Časové okno: Baseline, Week 12
|
The percentage involvement of psoriasis on each participant's body surface area 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 change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.
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Baseline, Week 12
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Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score
Časové okno: Baseline, Week 12
|
The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days.
There is a 4-point scale for each item ranging from 0 (best) to 3 (worst).
The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity.
LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.
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Baseline, Week 12
|
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Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
Časové okno: Baseline, Week 12
|
The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work.
Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work.
Percentage is calculated as each score * 100 and ranges from 0 to 100; greater scores indicate greater impairment.
LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.
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Baseline, Week 12
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Časové okno: Baseline, Week 12
|
The SF-36 is a participant-reported outcome measure evaluating participant's health status.
It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health.
Items are answered on Likert scales of varying lengths.
The 8 domains are regrouped into the PCS and MCS scores.
The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
In this study, the SF-36 acute version was used, which has a 1 week recall period.
LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.
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Baseline, Week 12
|
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Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity
Časové okno: Baseline, 12 weeks
|
The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.
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Baseline, 12 weeks
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Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement
Časové okno: Week 12
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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 to 72.
The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.
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Week 12
|
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Percentage of Participants With Anti-Ixekizumab Antibodies
Časové okno: Baseline to Week 12
|
Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
Percentage was calculated based on the # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
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Baseline to Week 12
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
- Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
- Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.
- Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.
- Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.
- Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.
- Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9. Erratum In: Am J Clin Dermatol. 2018 Mar 29;:
- Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
18. května 2012
Primární dokončení (Aktuální)
25. března 2014
Dokončení studie (Aktuální)
18. června 2019
Termíny zápisu do studia
První předloženo
10. května 2012
První předloženo, které splnilo kritéria kontroly kvality
10. května 2012
První zveřejněno (Odhad)
14. května 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
26. června 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. června 2020
Naposledy ověřeno
1. srpna 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Kožní choroby
- Kožní onemocnění, papuloskvamózní
- Psoriáza
- Fyziologické účinky léků
- Agenti periferního nervového systému
- Analgetika
- Agenti smyslového systému
- Protizánětlivé látky, nesteroidní
- Analgetika, nenarkotika
- Protizánětlivé látky
- Antirevmatika
- Imunosupresivní látky
- Imunologické faktory
- Gastrointestinální látky
- Dermatologická činidla
- Etanercept
- Ixekizumab
Další identifikační čísla studie
- 12973
- I1F-MC-RHBA (Jiný identifikátor: Eli Lilly and Company)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Plan Description:
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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .