A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
10 giugno 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens.
There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1257
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Brno, Cechia, 656 91
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Novy Jicin, Cechia, 741 01
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Plzen-Bory, Cechia, 305-99
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Praha, Cechia, 100 34
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Bucheon, Corea, Repubblica di, 420-717
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Pusan, Corea, Repubblica di, 602-739
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Seongnam, Corea, Repubblica di, 463-707
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Seoul, Corea, Repubblica di, 100799
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Berlin, Germania, 10789
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Darmstadt, Germania, 64283
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Kiel, Germania, 24148
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Mahlow, Germania, 15831
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Munster, Germania, 48159
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Osaka, Giappone, 545-8586
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Takaoka, Giappone, 9330871
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Tsu, Giappone, 514-8507
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Mexicali, Messico, 21100
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Mexico City, Messico, 3100
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Monterrey, Messico, 64060
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Morelia, Messico, CP 58249
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Bialystok, Polonia, 15-351
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Gdansk, Polonia, 80-546
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Kielce, Polonia, 25-316
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Krakow, Polonia, 30-438
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Lodz, Polonia, 90-265
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Swidnik, Polonia, 21-040
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Szczecin, Polonia, 70-332
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Wroclaw, Polonia, 51-318
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Caguas, Porto Rico, 00727
- Office of Dr. Samuel Sanchez PSC
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Carolina, Porto Rico, 00985
- Office of Dr. Alma M. Cruz
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Ponce, Porto Rico, 00716
- Ponce School of Medicine CAIMED Center
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San Juan, Porto Rico, 00909
- GCM Medical Group PSC
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San Juan, Porto Rico, 00918
- Mindful Medical Research
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Bucuresti, 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
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Constanta, Romania, 900125
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Craiova, Romania, 200642
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Alabama
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Birmingham, Alabama, Stati Uniti, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, Stati Uniti, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, Stati Uniti, 90212
- David Stoll, M.D.
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Los Angeles, California, Stati Uniti, 90045
- Dermatology Research Associates
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Sacramento, California, Stati Uniti, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, Stati Uniti, 92108
- Medical Center for Clinical Research
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San Diego, California, Stati Uniti, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, Stati Uniti, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Stati Uniti, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, Stati Uniti, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, Stati Uniti, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, Stati Uniti, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, Stati Uniti, 34471
- Renstar Medical Research
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Ormond Beach, Florida, Stati Uniti, 32174
- Ameriderm Research
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Tampa, Florida, Stati Uniti, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, Stati Uniti, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, Stati Uniti, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, Stati Uniti, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, Stati Uniti, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, Stati Uniti, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, Stati Uniti, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, Stati Uniti, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, Stati Uniti, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, Stati Uniti, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, Stati Uniti, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, Stati Uniti, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, Stati Uniti, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, Stati Uniti, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, Stati Uniti, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, Stati Uniti, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Stati Uniti, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, Stati Uniti, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Stati Uniti, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Stati Uniti, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, Stati Uniti, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, Stati Uniti, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, Stati Uniti, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, Stati Uniti, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, Stati Uniti, 78705
- Austin Dermatology Associates
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Dallas, Texas, Stati Uniti, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Stati Uniti, 77004
- Center For Clinical Studies
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Houston, Texas, Stati Uniti, 77065
- Center For Clinical Studies
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Pflugerville, Texas, Stati Uniti, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, Stati Uniti, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, Stati Uniti, 77598
- Center For Clinical Studies
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, Stati Uniti, 98101
- Dermatology Associates
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Tacoma, Washington, Stati Uniti, 98405
- MultiCare Health System
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Wenatchee, Washington, Stati Uniti, 98801
- Wenatchee Valley Hospital & Clinics
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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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Budapest, Ungheria, 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, Ungheria, 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, Ungheria, 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, Ungheria, 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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SQ amministrato
Administered SQ
Altri nomi:
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Sperimentale: 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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SQ amministrato
Administered SQ
Altri nomi:
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Sperimentale: 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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SQ amministrato
Administered SQ
Altri nomi:
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Sperimentale: 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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SQ amministrato
Administered SQ
Altri nomi:
|
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Sperimentale: 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
SQ amministrato
Administered SQ
Altri nomi:
|
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Sperimentale: 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52.
Placebo administered SQ, Q2W to maintain blind.
|
SQ amministrato
Administered SQ
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Achieving sPGA (0)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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])
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2015
Completamento primario (Effettivo)
1 novembre 2016
Completamento dello studio (Effettivo)
3 agosto 2017
Date di iscrizione allo studio
Primo inviato
30 luglio 2015
Primo inviato che soddisfa i criteri di controllo qualità
30 luglio 2015
Primo Inserito (Stima)
31 luglio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 giugno 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 giugno 2020
Ultimo verificato
1 giugno 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 15988
- I1F-MC-RHBP (Altro identificatore: Eli Lilly and Company)
- 2015-000190-12 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Periodo di condivisione 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.
Criteri di accesso alla condivisione IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .