En undersøgelse af deltagere med moderat til svær psoriasis (UNCOVER-3) (UNCOVER-3)
17. juli 2020 opdateret af: Eli Lilly and Company
En 12-ugers multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse, der sammenligner effektiviteten og sikkerheden af LY2439821 med Etanercept og placebo hos patienter med moderat til svær plakpsoriasis med en langvarig forlængelsesperiode
Denne undersøgelse vil vurdere sikkerheden og effektiviteten af ixekizumab (LY2439821) sammenlignet med etanercept og placebo hos deltagere med moderat til svær kronisk plaque-psoriasis.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
1346
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, C1055AA0
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Ciudad Autónoma De Buenosaire, Argentina, C1199ABD
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Plovdiv, Bulgarien, 4000
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Sofia, Bulgarien, 1632
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Varna, Bulgarien, 9010
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Alberta
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Calgary, Alberta, Canada, T3A 2N1
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British Columbia
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Vancouver, British Columbia, Canada, V5Z-3Y1
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H0A2
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Ontario
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Brampton, Ontario, Canada, L6R 0W3
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Ottawa, Ontario, Canada, K2G 6E2
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Richmond Hill, Ontario, Canada, L4B 1A5
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Waterloo, Ontario, Canada, N2J 1C4
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Windsor, Ontario, Canada, N8W5L7
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Quebec
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Drummondville, Quebec, Canada, J2B 5L4
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Montreal, Quebec, Canada, H2K4L5
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Santiago, Chile, 8420383
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Krasnodar, Den Russiske Føderation, 350020
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Moscow, Den Russiske Føderation, 127473
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Saint Petersburg, Den Russiske Føderation, 194356
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Sankt-Peterburg, Den Russiske Føderation, 195112
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Smolensk, Den Russiske Føderation, 214019
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Yaroslavl, Den Russiske Føderation, 150002
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California
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Anaheim, California, Forenede Stater, 92801
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Bakersfield, California, Forenede Stater, 93309
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Bell Gardens, California, Forenede Stater, 90201
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Beverly Hills, California, Forenede Stater, 90212
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Irvine, California, Forenede Stater, 92697
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Los Angeles, California, Forenede Stater, 90045
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Oceanside, California, Forenede Stater, 92056
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San Diego, California, Forenede Stater, 92123
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Santa Monica, California, Forenede Stater, 90404
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
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Florida
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Edgewater, Florida, Forenede Stater, 32132
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Jacksonville, Florida, Forenede Stater, 32216
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Miami, Florida, Forenede Stater, 33144
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Ocala, Florida, Forenede Stater, 34471
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Ormond Beach, Florida, Forenede Stater, 32174
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
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Chicago, Illinois, Forenede Stater, 60611
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Skokie, Illinois, Forenede Stater, 60077
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46256
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50265
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40217
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Owensboro, Kentucky, Forenede Stater, 42303
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68144
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Nevada
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Henderson, Nevada, Forenede Stater, 89074
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New Hampshire
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Newington, New Hampshire, Forenede Stater, 03801
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New Jersey
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East Windsor, New Jersey, Forenede Stater, 08520
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
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New York
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New York, New York, Forenede Stater, 10075
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Stony Brook, New York, Forenede Stater, 11790
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North Carolina
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High Point, North Carolina, Forenede Stater, 27262
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Winston-Salem, North Carolina, Forenede Stater, 27157
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Oregon
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Portland, Oregon, Forenede Stater, 97223
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Pennsylvania
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Hazleton, Pennsylvania, Forenede Stater, 18201
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
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Texas
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Dallas, Texas, Forenede Stater, 75246
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San Antonio, Texas, Forenede Stater, 78229
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
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West Jordan, Utah, Forenede Stater, 84088
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Monterrey, Mexico, 64460
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Bialystok, Polen, 15-017
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Krakow, Polen, 30-510
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Warsaw, Polen, 02-201
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Augsburg, Tyskland, 86179
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Berlin, Tyskland, 13125
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Bonn, Tyskland, 53111
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Dresden, Tyskland, 01069
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Erfurt, Tyskland, 99084
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Ergolding, Tyskland, 84038
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Frankfurt, Tyskland, 60596
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Freiburg, Tyskland, 79100
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Freising, Tyskland, 85354
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Friedrichshafen, Tyskland, 88045
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Gera, Tyskland, 07548
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Hamburg, Tyskland, 20253
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Hanau, Tyskland, 63450
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Kiel, Tyskland, 24148
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Leipzig, Tyskland, 04103
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Mahlow, Tyskland, 15831
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Mainz, Tyskland, 55131
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Mannheim, Tyskland, 68167
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Mönchengladbach, Tyskland, 41236
- 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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Münster, 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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Northeim, Tyskland, 37154
- 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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Schwerin, Tyskland, 19055
- 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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Würzburg, Tyskland, 97080
- 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, 1036
- 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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Kecskemet, Ungarn, 6000
- 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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Mako, Ungarn, 6900
- 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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Miskolc, Ungarn, 3529
- 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, 5900
- 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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Pecs, Ungarn, 7632
- 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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Szeged, Ungarn, H-6720
- 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, H-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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Szombathely, Ungarn, 9700
- 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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Veszprem, Ungarn, 8200
- 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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Præsenterer med kronisk plakpsoriasis baseret på en bekræftet diagnose af kronisk psoriasis i mindst 6 måneder før randomisering
- Mindst 10 % kropsoverfladeareal (BSA) af psoriasis ved screening og ved randomisering
- Static Physician Global Assessment (sPGA) score på mindst 3 og Psoriasis Area and Severity Index (PASI) score på mindst 12 ved screening og ved randomisering
- Kandidat til lysterapi og/eller systemisk terapi
- Mænd skal acceptere at bruge en pålidelig præventionsmetode eller forblive afholdende under undersøgelsen
- Kvinder skal acceptere at bruge pålidelig prævention eller forblive afholdende under undersøgelsen og i mindst 12 uger efter ophør af behandlingen
Ekskluderingskriterier:
- Pustulære, erytrodermiske og/eller guttate former for psoriasis
- Anamnese med lægemiddelinduceret psoriasis
- Tidligere brug af etanercept
- Klinisk signifikant opblussen af psoriasis i de 12 uger før randomisering
- Samtidig eller nylig brug af ethvert biologisk middel
- Modtaget ikke-biologisk systemisk psoriasisbehandling eller fototerapi (inklusive psoralener og ultraviolet A [PUVA], ultraviolet B [UVB]) inden for de foregående 4 uger; eller havde topisk psoriasisbehandling inden for de foregående 2 uger før randomisering
- Kan ikke undgå overdreven soleksponering eller brug af solariekabiner i mindst 4 uger før randomisering og under undersøgelsen
- Har deltaget i et hvilket som helst studie med interleukin 17 (IL-17) antagonister, inklusive ixekizumab
- Alvorlig lidelse eller anden sygdom end plakpsoriasis
- Alvorlig infektion inden for de sidste 3 måneder
- Ammende eller ammende (ammende) kvinder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
4
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Placebo komparator: Placebo
Placebo for ixekizumab indgivet ved to subkutane injektioner i uge 0, derefter én subkutan injektion pr. doseringsregime 1 indtil uge 12. Placebo for etanercept administreret ved én subkutan injektion to gange ugentligt startende fra uge 0 op til uge 12.
I uge 12 bliver deltagerne tildelt doseringsregime 2.
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Administreret SC
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Aktiv komparator: 50 mg etanercept
Administreret ved SC-injektioner to gange ugentligt startende fra uge 0 op til uge 12.
I uge 12 er armen tildelt doseringsregime 2
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Administreret SC
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Eksperimentel: 80 mg ixekizumab doseringsregime 2
Indgivet ved to 80 mg SC-injektioner i uge 0, derefter en 80 mg SC-injektion pr. doseringsregime 2 indtil uge 264.
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Administreret SC
Andre navne:
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Eksperimentel: 80 mg ixekizumab doseringsregime 1
Indgivet ved to 80 milligram (mg) subkutane (SC) injektioner i uge 0, derefter en 80 mg SC-injektion pr. doseringsregime 1 indtil uge 12.
I uge 12 er armen tildelt doseringsregime 2.
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Administreret SC
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antal deltagere, der opnår en Static Physician Global Assessment (sPGA) på (0, 1) (Ixekizumabs effekt hos deltagere med moderat til svær kronisk plakpsoriasis. Mål: sPGA)
Tidsramme: Uge 12
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SPGA er en læges bestemmelse af deltagerens psoriasislæsioner samlet på et givet tidspunkt kategoriseret efter beskrivelser for induration, erytem og skalering.
Til analyse af responser vurderes deltagerens psoriasis som klar (0), minimal (1), mild (2), moderat (3), svær (4) eller meget svær (5).
En sPGA (0,1) respons blev defineret som en post-baseline sPGA score på 0 eller 1.
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Uge 12
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Antal deltagere, der opnår psoriasisområde og sværhedsindeks ≥75 % (PASI 75) Forbedring (effekt af Ixekizumab hos deltagere med moderat til svær kronisk plakpsoriasis. Mål: PASI)
Tidsramme: Uge 12
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PASI kombinerer vurderinger af omfanget af kropsoverflade involvering i 4 anatomiske regioner (hoved, krop, arme og ben) og sværhedsgraden af afskalning (afskalning), erytem og plakforhårdning/-infiltration (tykkelse) i hver region, hvilket giver efter. en samlet score på 0 for ingen psoriasis til 72 for den mest alvorlige sygdom.
Deltagere, der opnåede PASI 75, blev defineret som at have en forbedring på mindst 75 % i PASI-scorerne sammenlignet med baseline.
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Uge 12
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antal deltagere, der opnår en sPGA (0) (Ixekizumabs effekt hos deltagere med moderat til svær kronisk plakpsoriasis. Mål: sPGA)
Tidsramme: Uge 12
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SPGA er en læges bestemmelse af deltagerens psoriasislæsioner samlet på et givet tidspunkt kategoriseret efter beskrivelser for induration, erytem og skalering.
Til analyse af responser vurderes deltagerens psoriasis som klar (0), minimal (1), mild (2), moderat (3), svær (4) eller meget svær (5).
En sPGA (0) respons blev defineret som en post-baseline sPGA score på 0.
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Uge 12
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Antal deltagere, der opnår ≥90 % (PASI 90) forbedring (effekt af Ixekizumab hos deltagere med moderat til svær kronisk plakpsoriasis. Mål: PASI)
Tidsramme: Uge 12
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PASI kombinerer vurderinger af omfanget af kropsoverflade involvering i 4 anatomiske regioner (hoved, krop, arme og ben) og sværhedsgraden af afskalning (afskalning), erytem og plakforhårdning/-infiltration (tykkelse) i hver region, hvilket giver efter. en samlet score på 0 for ingen psoriasis til 72 for den mest alvorlige sygdom.
Deltagere, der opnåede PASI 90, blev defineret som at have en forbedring på mindst 90 % i PASI-scorerne sammenlignet med baseline.
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Uge 12
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Antal deltagere, der opnår 100 % (PASI 100) forbedring (effekt af Ixekizumab hos deltagere med moderat til svær kronisk plakpsoriasis. Mål: PASI)
Tidsramme: Uge 12
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PASI kombinerer vurderinger af omfanget af kropsoverflade involvering i 4 anatomiske regioner (hoved, krop, arme og ben) og sværhedsgraden af afskalning (afskalning), erytem og plakforhårdning/-infiltration (tykkelse) i hver region, hvilket giver efter. en samlet score på 0 for ingen psoriasis til 72 for den mest alvorlige sygdom.
Deltagere, der opnåede PASI 100, blev defineret som at have en forbedring på mindst 100 % i PASI-scorerne sammenlignet med baseline.
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Uge 12
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Antal deltagere, der opnår en kløende numerisk vurderingsskala (NRS) ≥4 point reduktion [livskvalitet og resultatvurderinger. Mål: Patientrapporterede resultater (PRO)]
Tidsramme: Uge 12
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Itch NRS er en deltageradministreret enkelt-element 11-punkts horisontal skala forankret ved 0 og 10, hvor 0 repræsenterer "ingen kløe" og 10 repræsenterer "værst tænkelige kløe".
Deltagerne angiver deres overordnede sværhedsgrad af kløe fra Psoriasis ved at sætte en ring om det tal, der bedst beskriver det værste niveau af kløe i de seneste 24 timer.
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Uge 12
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Ændring fra baseline i Dermatology Life Quality Index (DLQI) Total Score
Tidsramme: Baseline, uge 12
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DLQI er et simpelt, deltageradministreret, 10 spørgsmål, valideret, livskvalitetsspørgeskema, der dækker 6 domæner: symptomer og følelser, daglige aktiviteter, fritid, arbejde og skole, personlige relationer og behandling.
Svarkategorier inkluderer "slet ikke", "meget" og "meget", med tilsvarende score på henholdsvis 1, 2 og 3, og ubesvarede ("ikke relevant") svar scoret som "0".
Totalerne spænder fra 0 til 30 (mindre til mere svækkelse), og en ændring på 5 point fra baseline anses for at være klinisk relevant.
Least Square (LS) Middel i total DLQI-score blev beregnet ved brug af Mixed Model Repeated Measures (MMRM) med baseline-score som kovariat, behandling, pooled center, besøg og behandling-for-besøg interaktion som faste effekter.
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Baseline, uge 12
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Ændring fra baseline i Nail Psoriasis Severity Index (NAPSI)-score
Tidsramme: Baseline, uge 12
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NAPSI er et numerisk, reproducerbart, objektivt værktøj, der bruges til at evaluere sværhedsgraden af fingerneglelejepsoriasis og fingerneglematrixpsoriasis efter involveret område i fingernegleenheden.
Fingerneglen er opdelt med imaginære vandrette og langsgående linjer i kvadranter.
Hver fingernegl får en score for fingerneglelejepsoriasis: 0 (ingen) til 4 (psoriasis i 4 kvadranter af neglen) og fingerneglematrixpsoriasis (0 til 4) afhængigt af tilstedeværelse (score på 1) eller fravær (score på 0 ) af nogen af funktionerne ved fingernegleleje og fingerneglematrixpsoriasis i hver kvadrant.
NAPSI-score for en fingernegl er summen af score i fingernegleleje og fingerneglematrix fra hver kvadrant (maksimalt 8).
Hver fingernegl evalueres, og summen af alle fingernegle er den samlede NAPSI-score (interval, 0 til 80).
LS-middelværdier i NAPSI-score blev beregnet ved hjælp af MMRM med baseline-score som kovariat, behandling, pooled center, besøg og behandling-for-besøg interaktion som faste effekter.
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Baseline, uge 12
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Procent af kropsoverfladeareal (BSA) involvering af psoriasis
Tidsramme: Uge 12
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Procentdel involvering af psoriasis på hver deltagers kropsoverflade blev vurderet af investigator på en kontinuerlig skala fra 0% (ingen involvering) til 100% (fuld involvering), hvor 1% svarer til størrelsen af deltagerens hånd (inklusive håndflade, fingre og tommelfinger).
LS-middelværdier i BSA blev beregnet ved hjælp af MMRM med baseline BSA som kovariat, behandling, pooled center, besøg og behandling-for-besøg interaktion som faste effekter.
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Uge 12
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Ændring fra baseline i Psoriasis Scalp Severity Index (PSSI)-score
Tidsramme: Baseline, uge 12
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PSSI er en sammensat score, der spænder fra 0 (bedst) til 72 (dårligst), afledt af sumscorerne for erytem, induration og afskalning ganget med en score for omfanget af det involverede hovedbundsområde.
LS-middelværdier i PSSI-score blev beregnet ved hjælp af MMRM med baseline-score som kovariat, behandling, pooled center, besøg og behandling-for-besøg interaktion som faste effekter.
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Baseline, uge 12
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Ændring fra baseline i hurtig opgørelse over depressiv symptomatologi-selvrapport 16 punkter (QIDS-SR16) Samlet score [livskvalitet og resultatvurderinger. Mål: Patientrapporterede resultater (PRO)]
Tidsramme: Baseline, uge 12
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QIDS-SR16 er et selvadministreret instrument med 16 elementer, hvor en deltager bliver bedt om at overveje hvert udsagn, som det relaterer til den måde, de har følt de sidste 7 dage.
Der er en 4-punkts skala for hvert punkt, der går fra 0 (bedst) til 3 (dårligst).
De 16 punkter er scoret til at give 9 individuelle depressionsdomæner (trist humør, koncentration, selvkritik, selvmordstanker, interesse, energi/træthed, søvnforstyrrelser [initial, middel og sen søvnløshed eller hypersomni], fald/øgning i appetit/vægt , og psykomotorisk agitation/retardering), som summeres til at give en enkelt score fra 0 til 27, hvor højere score angiver større symptomsværhed.
LS-middelværdier i total QIDS-SR16-score blev beregnet ved hjælp af analysen af kovariansmodellen (ANCOVA) med behandling, samlet center- og baseline QIDS totalscore.
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Baseline, uge 12
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Ændring fra baseline i alle resultater af arbejdet Produktivitetsaktivitet Svækkelsesspørgeskema-Psoriasis (WPAI-PSO)
Tidsramme: Baseline, uge 12
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WPAI-PSO er et 6-element instrument, der bruges til at vurdere virkningen af psoriasis på produktivitetssvækkelse inden for de seneste 7 dage.
Det har fire domæner: fravær, tilstedeværelse (reduceret produktivitet, mens du er på arbejde), en samlet arbejdsnedsættelsesscore og svækkelse i daglige aktiviteter, der udføres uden for arbejdet.
Fire scores er udledt som procenter: fravær, tilstedeværelse, generel arbejdsnedsættelse (fravær og tilstedeværelse) og svækkelse i aktiviteter, der udføres uden for arbejdet.
Procentdelen beregnes som: hver score * 100 og varierede fra 0 til 100.
Højere score indikerer større svækkelse af produktiviteten.
LS-middelværdier i hver WPAI-PSO-score blev beregnet ved hjælp af ANCOVA-modellen med behandling, poolet center og baseline WPAI-PSO-score.
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Baseline, uge 12
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Ændring fra baseline i medicinske resultater Studie 36-Item Short Form (SF-36) Sundhedsundersøgelse, Physical Component Summary (PCS) og Mental Component Summary (MCS) resultater
Tidsramme: Baseline, uge 12
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SF-36 er et deltagerrapporteret resultatmål, der evaluerer deltagerens helbredsstatus.
Den består af 36 punkter, der dækker 8 domæner: fysisk funktion, rollefysisk, følelsesmæssig rolle, kropslig smerte, vitalitet, social funktion, mental sundhed og generel sundhed.
Emner besvares på Likert-skalaer af varierende længde.
De 8 domæner er omgrupperet i PCS- og MCS-resultaterne.
Opsummeringsscorerne spænder fra 0 til 100, hvor højere score indikerer bedre funktionsniveauer og/eller bedre helbred.
I denne undersøgelse blev SF-36 akut versionen brugt, som har en tilbagekaldelsesperiode på 1 uge.
LS-middelværdier i SF-36-score blev beregnet ved hjælp af ANCOVA-modellen med behandling, pooled center og baseline SF-36-score.
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Baseline, uge 12
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Ændring fra baseline i patientens globale vurdering af sygdoms sværhedsgrad
Tidsramme: Baseline, uge 12
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Patientens globale vurdering af sygdomssværhedsgrad er et enkeltelement-deltagerrapporteret resultatmål, hvor deltagerne bliver bedt om at vurdere sværhedsgraden af deres psoriasis "i dag" fra 0 (Klar) = ingen psoriasis, til 5 (alvorlig) = den værste deres psoriasis. psoriasis nogensinde har været.
LS Means in Patient's Global Assessment of Disease Severity-score blev beregnet ved hjælp af MMRM med baseline-score som kovariat, behandling, pooled center, besøg og behandling-for-besøg interaktion som faste effekter.
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Baseline, uge 12
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Antal deltagere, der opnår Palmoplantar PASI på ≥50 % (PPASI 50) forbedring
Tidsramme: Uge 12
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Palmoplantar PASI er en sammensat score afledt af sumscorerne for erytem, induration og afskalning multipliceret med en score for omfanget af involvering af håndfladen og sålområdet, der spænder fra 0 til 72.
Deltagere, der opnåede PPASI 50, blev defineret som at have en forbedring på mindst 50 % i PPASI-scorerne sammenlignet med baseline.
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Uge 12
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Antal deltagere, der opnår Palmoplantar PASI på ≥75 % (PPASI 75) forbedring
Tidsramme: Uge 12
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Palmoplantar PASI er en sammensat score afledt af sumscorerne for erytem, induration og afskalning multipliceret med en score for omfanget af involvering af håndfladen og sålområdet, der spænder fra 0 til 72.
Deltagere, der opnåede PPASI 75, blev defineret som at have en forbedring på mindst 75 % i PPASI-scorerne sammenlignet med baseline.
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Uge 12
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Antal deltagere, der opnår Palmoplantar PASI på 100 % (PPASI 100) forbedring
Tidsramme: Uge 12
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Palmoplantar PASI er en sammensat score afledt af sumscorerne for erytem, induration og afskalning multipliceret med en score for omfanget af involvering af håndfladen og sålområdet, der spænder fra 0 til 72.
Deltagere, der opnåede PPASI 100, blev defineret som at have en forbedring på 100 % i PPASI-scorerne sammenlignet med baseline.
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Uge 12
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Antal deltagere med behandlingsfremkaldte anti-Ixekizumab-antistoffer
Tidsramme: Uge 12
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Procentdelen af deltagere med behandlingsfremkomne positive anti-ixekizumab-antistoffer på ethvert tidspunkt efter baseline blev opsummeret efter behandlingsgruppe.
Procentdel af deltagere med behandlingsfremkomne positive anti-ixekizumab-antistoffer blev beregnet som: antal deltagere med en evaluerbar baseline-prøve og ≥1 evaluerbar post-baseline-prøve/antal deltagere i analysepopulationen * 100.
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Uge 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- Blauvelt A, Lebwohl MG, Mabuchi T, Leung A, Garrelts A, Crane H, ElMaraghy H, Patel H, Ridenour T, See K, Gallo G, Paul C. Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021 Aug;85(2):360-368. doi: 10.1016/j.jaad.2020.11.022. Epub 2020 Nov 28.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
28. juli 2012
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
22. maj 2014
Studieafslutning (Faktiske)
Studieafslutning
22. juli 2019
Datoer for studieregistrering
Først indsendt
Først indsendt
18. juli 2012
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
18. juli 2012
Først opslået (Skøn)
Først opslået
20. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
28. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2020
Sidst verificeret
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Hudsygdomme, Papulosquamous
- Psoriasis
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Dermatologiske midler
- Etanercept
- Ixekizumab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 13685
- I1F-MC-RHBC (Anden identifikator: Eli Lilly and Company)
Plan for individuelle deltagerdata (IPD)
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JA
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IPD-delingstidsramme
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IPD-delingsadgangskriterier
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IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
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