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A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)

10. Juni 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1257

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, C1425DKG
        • 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.
      • Mendoza, Argentinien, 5500
        • 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.
  • Australien
      • Benowa, Australien, 4217
        • 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.
      • Carlton, Australien, 3053
        • 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.
      • Darlinghurst, Australien, 2010
        • 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.
      • Fremantle, Australien, 6160
        • 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.
      • Phillip, Australien, 02606
        • 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.
      • Woolloongabba, Australien, 4102
        • 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.
  • Deutschland
      • Berlin, Deutschland, 10789
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Darmstadt, Deutschland, 64283
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kiel, Deutschland, 24148
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mahlow, Deutschland, 15831
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Munster, Deutschland, 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.
  • Japan
      • 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.
      • Takaoka, Japan, 9330871
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tsu, Japan, 514-8507
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Kanada
      • Barrie, Kanada, L4M 6L2
        • 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.
      • Calgary, Kanada, T2G 1B1
        • 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.
      • Halifax, Kanada, B3H1Z2
        • 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.
      • Hamilton, Kanada, L8N1V6
        • 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.
      • London, Kanada, N6A 3H7
        • 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.
      • Markham, Kanada, L3P1X2
        • 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.
      • Montreal, Kanada, H2K4L5
        • 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.
      • Oakville, Kanada, L6J7W5
        • 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.
      • Peterborough, Kanada, K9J 5K2
        • 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.
      • Quebec, Kanada, G1V 4X7
        • 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.
      • Richmond Hill, Kanada, L4B 1A5
        • 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.
      • Sherbrooke, Kanada, J1J 2G2
        • 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.
      • Surrey, Kanada, V3V 0C6
        • 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.
      • Waterloo, Kanada, N2J 1C4
        • 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.
      • Windsor, Kanada, N8W 1E6
        • 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.
  • Korea, Republik von
      • Bucheon, Korea, Republik von, 420-717
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pusan, Korea, Republik von, 602-739
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seongnam, Korea, Republik von, 463-707
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republik von, 100799
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Mexiko
      • Mexicali, Mexiko, 21100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mexico City, Mexiko, 3100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Monterrey, Mexiko, 64060
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Morelia, Mexiko, CP 58249
        • 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.
  • Polen
      • Bialystok, Polen, 15-351
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gdansk, Polen, 80-546
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kielce, Polen, 25-316
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Krakow, Polen, 30-438
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lodz, Polen, 90-265
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Swidnik, Polen, 21-040
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szczecin, Polen, 70-332
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wroclaw, Polen, 51-318
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Office of Dr. Samuel Sanchez PSC
      • Carolina, Puerto Rico, 00985
        • Office of Dr. Alma M. Cruz
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine CAIMED Center
      • San Juan, Puerto Rico, 00909
        • GCM Medical Group PSC
      • San Juan, Puerto Rico, 00918
        • Mindful Medical Research
  • Rumänien
      • Bucuresti, Rumänien, 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.
      • Cluj Napoca, Rumänien, 400006
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Constanta, Rumänien, 900125
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Craiova, Rumänien, 200642
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Taiwan
      • 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.
      • 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.
  • Tschechien
      • Brno, Tschechien, 656 91
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Novy Jicin, Tschechien, 741 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Plzen-Bory, Tschechien, 305-99
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Praha, Tschechien, 100 34
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ungarn
      • Budapest, Ungarn, 1238
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • Oroshaza, Ungarn, 5901
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szolnok, Ungarn, 5000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35205
        • Total Skin and Beauty Dermatology Center PC
    • California
      • Anaheim, California, Vereinigte Staaten, 92801
        • Anaheim Clinical Trials, LLC
      • Beverly Hills, California, Vereinigte Staaten, 90212
        • David Stoll, M.D.
      • Los Angeles, California, Vereinigte Staaten, 90045
        • Dermatology Research Associates
      • Sacramento, California, Vereinigte Staaten, 95819
        • Center for Dermatology and Laser Surgery
      • San Diego, California, Vereinigte Staaten, 92108
        • Medical Center for Clinical Research
      • San Diego, California, Vereinigte Staaten, 92123
        • University Clinical Trials, Inc.
      • Santa Monica, California, Vereinigte Staaten, 90404
        • Clinical Science Institute
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80209
        • Cherry Creek Research, Inc
    • Florida
      • Coral Gables, Florida, Vereinigte Staaten, 33134
        • Florida Academic Dermatology Centers
      • DeLand, Florida, Vereinigte Staaten, 32720
        • Avail Clinical Research LLC
      • Jacksonville, Florida, Vereinigte Staaten, 32216
        • Jacksonville Center for Clinical Research
      • Ocala, Florida, Vereinigte Staaten, 34471
        • Renstar Medical Research
      • Ormond Beach, Florida, Vereinigte Staaten, 32174
        • Ameriderm Research
      • Tampa, Florida, Vereinigte Staaten, 33624
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30342
        • Advanced Medical Research
    • Illinois
      • Darien, Illinois, Vereinigte Staaten, 60561
        • University Dermatology
    • Indiana
      • Evansville, Indiana, Vereinigte Staaten, 47714
        • Deaconess Clinic Inc
      • Indianapolis, Indiana, Vereinigte Staaten, 46256
        • Dawes Fretzin Clinical Research
      • South Bend, Indiana, Vereinigte Staaten, 46617
        • The South Bend Clinic
    • Kansas
      • Overland Park, Kansas, Vereinigte Staaten, 66215
        • Kansas City Dermatology, PA
      • Wichita, Kansas, Vereinigte Staaten, 67207
        • Heartland Research Associates
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • Dermatology Specialist
    • Louisiana
      • Lake Charles, Louisiana, Vereinigte Staaten, 70605
        • Dr. Shondra Smith MD
    • Maryland
      • Rockville, Maryland, Vereinigte Staaten, 20850
        • DermAssociates, P.C.
    • Massachusetts
      • Beverly, Massachusetts, Vereinigte Staaten, 01915
        • ActivMed Practices & Research, Inc
    • Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63117
        • Central Dermatology PC
    • New Hampshire
      • Newington, New Hampshire, Vereinigte Staaten, 03801
        • ActivMed Practices & Research, Inc
    • New Jersey
      • East Windsor, New Jersey, Vereinigte Staaten, 08520
        • Psoriasis Treatment Center of Central New Jersey
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87106-5239
        • Academic Dermatology Associates
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Mount Sinai School of Medicine Dermatology Clinical Trials
      • Rochester, New York, Vereinigte Staaten, 14623
        • Skin Search of Rochester, Inc
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27516
        • University of North Carolina Dermatology and Skin Cancer Center
      • Wilmington, North Carolina, Vereinigte Staaten, 28401
        • PMG Research of Wilmington, LLC
      • Wilmington, North Carolina, Vereinigte Staaten, 28405
        • Wilmington Dermatology Center
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27103
        • Piedmont Medical Research
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44106-5055
        • University Hospitals of Cleveland
    • Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74135
        • Healthcare Research Consultant
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, Vereinigte Staaten, 97223
        • Oregon Medical Research Center
    • Pennsylvania
      • Exton, Pennsylvania, Vereinigte Staaten, 19341
        • Dermatology and Skin Surgery Center
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • University of Pittsburgh Medical Center
      • Wyomissing, Pennsylvania, Vereinigte Staaten, 19610
        • Pennsylvania Regional Center for Arthritis & Osteoarthritis
      • Yardley, Pennsylvania, Vereinigte Staaten, 19067
        • Yardley Dermatology
    • Rhode Island
      • Johnston, Rhode Island, Vereinigte Staaten, 02919
        • Clinical Partners LLC
    • South Carolina
      • Mount Pleasant, South Carolina, Vereinigte Staaten, 29464
        • Coastal Carolina Research Center, Inc.
    • Tennessee
      • Knoxville, Tennessee, Vereinigte Staaten, 37922
        • The Skin Wellness Center PC
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78705
        • Austin Dermatology Associates
      • Dallas, Texas, Vereinigte Staaten, 75246
        • Menter Dermatology Research Institute
      • Houston, Texas, Vereinigte Staaten, 77004
        • Center For Clinical Studies
      • Houston, Texas, Vereinigte Staaten, 77065
        • Center For Clinical Studies
      • Pflugerville, Texas, Vereinigte Staaten, 78660
        • Pflugerville Dermatology Clinical Research Center
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Clinical Trials of Texas, Inc.
      • Webster, Texas, Vereinigte Staaten, 77598
        • Center For Clinical Studies
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84132
        • University of Utah Medical Center
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23507
        • Virginia Clinical Research
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98101
        • Dermatology Associates
      • Tacoma, Washington, Vereinigte Staaten, 98405
        • MultiCare Health System
      • Wenatchee, Washington, Vereinigte Staaten, 98801
        • Wenatchee Valley Hospital & Clinics

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Placebo
Verwaltete SQ
Arzneimittel: Ixekizumab
Administered SQ
Andere Namen:
  • LY2439821
Experimental: 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.
Arzneimittel: Placebo
Verwaltete SQ
Arzneimittel: Ixekizumab
Administered SQ
Andere Namen:
  • LY2439821
Experimental: 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.
Arzneimittel: Placebo
Verwaltete SQ
Arzneimittel: Ixekizumab
Administered SQ
Andere Namen:
  • LY2439821
Experimental: 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.
Arzneimittel: Placebo
Verwaltete SQ
Arzneimittel: Ixekizumab
Administered SQ
Andere Namen:
  • LY2439821
Experimental: 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.
Arzneimittel: Placebo
Verwaltete SQ
Arzneimittel: Ixekizumab
Administered SQ
Andere Namen:
  • LY2439821
Experimental: 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.
Arzneimittel: Placebo
Verwaltete SQ
Arzneimittel: Ixekizumab
Administered SQ
Andere Namen:
  • LY2439821

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving sPGA (0)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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])
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline through Week 52
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
Baseline through Week 52

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Eli Lilly and Company

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2015

Primärer Abschluss (Tatsächlich)

1. November 2016

Studienabschluss (Tatsächlich)

3. August 2017

Studienanmeldedaten

Zuerst eingereicht

30. Juli 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juli 2015

Zuerst gepostet (Schätzen)

31. Juli 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2020

Zuletzt verifiziert

1. Juni 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 15988
  • I1F-MC-RHBP (Andere Kennung: Eli Lilly and Company)
  • 2015-000190-12 (EudraCT-Nummer)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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