A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)
10 juni 2020 uppdaterad av: Eli Lilly and Company
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
1257
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Buenos Aires, Argentina, C1425DKG
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Mendoza, Argentina, 5500
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Benowa, Australien, 4217
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Carlton, Australien, 3053
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Darlinghurst, Australien, 2010
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Fremantle, Australien, 6160
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Phillip, Australien, 02606
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Woolloongabba, Australien, 4102
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Alabama
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Birmingham, Alabama, Förenta staterna, 35205
- Total Skin and Beauty Dermatology Center PC
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California
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Anaheim, California, Förenta staterna, 92801
- Anaheim Clinical Trials, LLC
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Beverly Hills, California, Förenta staterna, 90212
- David Stoll, M.D.
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Los Angeles, California, Förenta staterna, 90045
- Dermatology Research Associates
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Sacramento, California, Förenta staterna, 95819
- Center for Dermatology and Laser Surgery
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San Diego, California, Förenta staterna, 92108
- Medical Center for Clinical Research
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San Diego, California, Förenta staterna, 92123
- University Clinical Trials, Inc.
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Santa Monica, California, Förenta staterna, 90404
- Clinical Science Institute
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Colorado
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Denver, Colorado, Förenta staterna, 80209
- Cherry Creek Research, Inc
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Florida
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Coral Gables, Florida, Förenta staterna, 33134
- Florida Academic Dermatology Centers
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DeLand, Florida, Förenta staterna, 32720
- Avail Clinical Research LLC
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Jacksonville, Florida, Förenta staterna, 32216
- Jacksonville Center for Clinical Research
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Ocala, Florida, Förenta staterna, 34471
- Renstar Medical Research
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Ormond Beach, Florida, Förenta staterna, 32174
- Ameriderm Research
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Tampa, Florida, Förenta staterna, 33624
- University of South Florida
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342
- Advanced Medical Research
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Illinois
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Darien, Illinois, Förenta staterna, 60561
- University Dermatology
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Indiana
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Evansville, Indiana, Förenta staterna, 47714
- Deaconess Clinic Inc
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Indianapolis, Indiana, Förenta staterna, 46256
- Dawes Fretzin Clinical Research
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South Bend, Indiana, Förenta staterna, 46617
- The South Bend Clinic
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Kansas
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Overland Park, Kansas, Förenta staterna, 66215
- Kansas City Dermatology, PA
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Wichita, Kansas, Förenta staterna, 67207
- Heartland Research Associates
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
- Dermatology Specialist
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Louisiana
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Lake Charles, Louisiana, Förenta staterna, 70605
- Dr. Shondra Smith MD
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Maryland
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Rockville, Maryland, Förenta staterna, 20850
- DermAssociates, P.C.
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Massachusetts
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Beverly, Massachusetts, Förenta staterna, 01915
- ActivMed Practices & Research, Inc
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63117
- Central Dermatology PC
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New Hampshire
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Newington, New Hampshire, Förenta staterna, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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East Windsor, New Jersey, Förenta staterna, 08520
- Psoriasis Treatment Center of Central New Jersey
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87106-5239
- Academic Dermatology Associates
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New York
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New York, New York, Förenta staterna, 10029
- Mount Sinai School of Medicine Dermatology Clinical Trials
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Rochester, New York, Förenta staterna, 14623
- Skin Search of Rochester, Inc
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27516
- University of North Carolina Dermatology and Skin Cancer Center
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Wilmington, North Carolina, Förenta staterna, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, Förenta staterna, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Förenta staterna, 27103
- Piedmont Medical Research
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106-5055
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74135
- Healthcare Research Consultant
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Oregon
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Portland, Oregon, Förenta staterna, 97210
- Oregon Dermatology and Research Center
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Portland, Oregon, Förenta staterna, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, Förenta staterna, 19341
- Dermatology and Skin Surgery Center
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Medical Center
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Wyomissing, Pennsylvania, Förenta staterna, 19610
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
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Yardley, Pennsylvania, Förenta staterna, 19067
- Yardley Dermatology
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Rhode Island
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Johnston, Rhode Island, Förenta staterna, 02919
- Clinical Partners LLC
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South Carolina
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Mount Pleasant, South Carolina, Förenta staterna, 29464
- Coastal Carolina Research Center, Inc.
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37922
- The Skin Wellness Center PC
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Texas
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Austin, Texas, Förenta staterna, 78705
- Austin Dermatology Associates
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Dallas, Texas, Förenta staterna, 75246
- Menter Dermatology Research Institute
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Houston, Texas, Förenta staterna, 77004
- Center for Clinical Studies
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Houston, Texas, Förenta staterna, 77065
- Center for Clinical Studies
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Pflugerville, Texas, Förenta staterna, 78660
- Pflugerville Dermatology Clinical Research Center
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San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas, Inc.
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Webster, Texas, Förenta staterna, 77598
- Center for Clinical Studies
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Utah
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Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah Medical Center
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507
- Virginia Clinical Research
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Washington
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Seattle, Washington, Förenta staterna, 98101
- Dermatology Associates
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Tacoma, Washington, Förenta staterna, 98405
- MultiCare Health System
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Wenatchee, Washington, Förenta staterna, 98801
- Wenatchee Valley Hospital & Clinics
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Osaka, Japan, 545-8586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Takaoka, Japan, 9330871
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Tsu, Japan, 514-8507
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Barrie, Kanada, L4M 6L2
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Calgary, Kanada, T2G 1B1
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Halifax, Kanada, B3H1Z2
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Hamilton, Kanada, L8N1V6
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London, Kanada, N6A 3H7
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Markham, Kanada, L3P1X2
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Montreal, Kanada, H2K4L5
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Oakville, Kanada, L6J7W5
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Peterborough, Kanada, K9J 5K2
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Quebec, Kanada, G1V 4X7
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Richmond Hill, Kanada, L4B 1A5
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Sherbrooke, Kanada, J1J 2G2
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Surrey, Kanada, V3V 0C6
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Waterloo, Kanada, N2J 1C4
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Windsor, Kanada, N8W 1E6
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Bucheon, Korea, Republiken av, 420-717
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Pusan, Korea, Republiken av, 602-739
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Seongnam, Korea, Republiken av, 463-707
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Seoul, Korea, Republiken av, 100799
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Mexicali, Mexiko, 21100
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Mexico City, Mexiko, 3100
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Monterrey, Mexiko, 64060
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Morelia, Mexiko, CP 58249
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Bialystok, Polen, 15-351
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Gdansk, Polen, 80-546
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Kielce, Polen, 25-316
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Krakow, Polen, 30-438
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Lodz, Polen, 90-265
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Swidnik, Polen, 21-040
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Szczecin, Polen, 70-332
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Wroclaw, Polen, 51-318
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Caguas, Puerto Rico, 00727
- Office of Dr. Samuel Sanchez PSC
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Carolina, Puerto Rico, 00985
- Office of Dr. Alma M. Cruz
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Ponce, Puerto Rico, 00716
- Ponce School of Medicine CAIMED Center
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San Juan, Puerto Rico, 00909
- GCM Medical Group PSC
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San Juan, Puerto Rico, 00918
- Mindful Medical Research
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Bucuresti, Rumänien, 011025
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Cluj Napoca, Rumänien, 400006
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Constanta, Rumänien, 900125
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Craiova, Rumänien, 200642
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Tainan, Taiwan, 70166
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Taipei, Taiwan, 10048
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Brno, Tjeckien, 656 91
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Novy Jicin, Tjeckien, 741 01
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Plzen-Bory, Tjeckien, 305-99
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Praha, Tjeckien, 100 34
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Berlin, Tyskland, 10789
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Darmstadt, Tyskland, 64283
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Kiel, Tyskland, 24148
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Mahlow, Tyskland, 15831
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Munster, Tyskland, 48159
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Budapest, Ungern, 1238
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Debrecen, Ungern, 4032
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Oroshaza, Ungern, 5901
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Szolnok, Ungern, 5000
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Present with chronic plaque psoriasis for at least 6 months prior to enrollment
- At least 10% BSA of psoriasis at screening and at enrollment
- sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
- Candidates for phototherapy and/or systemic therapy
- Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment
Exclusion Criteria:
- Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
- History of drug-induced psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
- Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
- Concurrent or recent use of any biologic agent
- Have participated in any study with ixekizumab
- Received a live vaccination within 12 weeks prior to enrollment
- Serious disorder or illness other than psoriasis
- Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
- Major surgery within 8 weeks of baseline, or will require surgery during the study
- Breastfeeding or nursing (lactating) women
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Administrerad SQ
Administered SQ
Andra namn:
|
|
Experimentell: 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.
|
Administrerad SQ
Administered SQ
Andra namn:
|
|
Experimentell: 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.
|
Administrerad SQ
Administered SQ
Andra namn:
|
|
Experimentell: 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.
|
Administrerad SQ
Administered SQ
Andra namn:
|
|
Experimentell: 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.
|
Administrerad SQ
Administered SQ
Andra namn:
|
|
Experimentell: 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.
|
Administrerad SQ
Administered SQ
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Tidsram: Week 52
|
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Week 52
|
|
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Tidsram: Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
|
Week 52
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Achieving sPGA (0)
Tidsram: Week 52
|
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Week 52
|
|
Percentage of Participants Achieving PASI 90
Tidsram: Week 52
|
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
|
Week 52
|
|
Percentage of Participants Achieving PASI 100
Tidsram: Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no Ps) to 72 (the most severe disease).
|
Week 52
|
|
Change From Baseline in PASI
Tidsram: Baseline, Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. |
Baseline, Week 52
|
|
Percent Improvement in PASI
Tidsram: Baseline, Week 52
|
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. |
Baseline, Week 52
|
|
Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
Tidsram: Baseline, Week 52
|
The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured. |
Baseline, Week 52
|
|
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Tidsram: Baseline, Week 52
|
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps.
This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit.
The fn is divided with imaginary horizontal and longitudinal lines into quadrants.
Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant.
The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8).
Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps).
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
Tidsram: Baseline, Week 52
|
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe).
The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Mean Change From Baseline in Palmoplantar PASI (PPASI)
Tidsram: Baseline, Week 52
|
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI).
The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
Tidsram: Baseline, Week 52
|
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable."
Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Baseline, Week 52
|
|
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
Tidsram: Week 52
|
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0."
Totals range from 0 to 30 (less to more impairment).
Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
|
Week 52
|
|
Change From Baseline in DLQI Total Score
Tidsram: Baseline, Week 52
|
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0."
Totals range from 0 to 30 (less to more impairment).
LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Change From Baseline in Itch NRS Score
Tidsram: Baseline, Week 52
|
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable."
Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Change From Baseline in Skin Pain Visual Analog Scale (VAS)
Tidsram: Baseline, Week 52
|
The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS.
Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain).
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
Tidsram: Baseline, Week 52
|
EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal.
The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain).
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
|
Baseline, Week 52
|
|
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Tidsram: Predose, Week 4, 12, 24, 36 and 52 Post dose
|
Trough concentrations at steady state of Ixekizumab were evaluated.
|
Predose, Week 4, 12, 24, 36 and 52 Post dose
|
|
Number of Participants With Anti-Ixekizumab Antibodies
Tidsram: Baseline through Week 52
|
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
|
Baseline through Week 52
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2015
Primärt slutförande (Faktisk)
1 november 2016
Avslutad studie (Faktisk)
3 augusti 2017
Studieregistreringsdatum
Först inskickad
30 juli 2015
Först inskickad som uppfyllde QC-kriterierna
30 juli 2015
Första postat (Uppskatta)
31 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2020
Senast verifierad
1 juni 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15988
- I1F-MC-RHBP (Annan identifierare: Eli Lilly and Company)
- 2015-000190-12 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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