A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Last updated: June 19, 2020
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Arthritis And Arthritic Pain

Joint Injuries

Psoriatic Arthritis

Treatment

N/A

Clinical Study ID

NCT02349295
14310
2011-002328-42
I1F-MC-RHBE
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

  • Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

  • Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

  • Men must agree to use a reliable method of birth control or remain abstinent duringthe study

  • Women must agree to use reliable birth control or remain abstinent during the studyand for at least 12 weeks after stopping treatment

  • Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

  • Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor dueto either an inadequate response (based on a minimum of 12 weeks on therapy) ordocumented intolerance.

Exclusion

Exclusion Criteria:

  • Current use of biologic agents for treatment of Ps or PsA

  • Inadequate response to greater than 2 biologic DMARDs

  • Current use of more than one cDMARDs

  • Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies otherthan PsA

  • Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonalantibody (MAb) therapy

  • Serious disorder or illness other than psoriatic arthritis

  • Serious infection within the last 3 months

  • Breastfeeding or nursing (lactating) women

Study Design

Total Participants: 363
Study Start date:
December 31, 2014
Estimated Completion Date:
June 26, 2019

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Coast Joint Care

    Maroochydore, Queensland 4558
    Australia

    Site Not Available

  • Emeritus Research

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • 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.

    Malvern East, Victoria 3145
    Australia

    Site Not Available

  • 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.

    Fitzroy, 3065
    Australia

    Site Not Available

  • CCBR Czech Prague, s.r.o.

    Praha, 13000
    Czechia

    Site Not Available

  • MEDICAL PLUS, s.r.o.

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • PV-MEDICAL s.r.o. Revmatologicka ambulance

    Zlin, 760 01
    Czechia

    Site Not Available

  • Hôpital Trousseau, CHRU de Tours

    Chambray-lès-Tours, 37170
    France

    Site Not Available

  • CHU de Montpellier-Hopital Arnaud de Villeneuve

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Chru De Nantes Hotel-Dieu

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • 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.

    Orleans, 45032
    France

    Site Not Available

  • Hopital Cochin

    Paris CEDEX 14, 75679
    France

    Site Not Available

  • Hopital Purpan

    Toulouse, 31059
    France

    Site Not Available

  • 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.

    Tours, 37044
    France

    Site Not Available

  • CHU Brabois

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet

    Herne, Nordrhein-Westfalen 44649
    Germany

    Site Not Available

  • Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum

    Dresden, Sachsen 01067
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universität Leipzig - Universitätsklinikum

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • HRF Hamburger Rheuma Forschungszentrum

    Hamburg, 20095
    Germany

    Site Not Available

  • 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.

    Zerbst, 39261
    Germany

    Site Not Available

  • 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.

    Bergamo, 24127
    Italy

    Site Not Available

  • Istituto Ortopedico Gaetano Pini

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera - Universitaria Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • 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.

    Roma, 00168
    Italy

    Site Not Available

  • 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.

    Rozzano, 20089
    Italy

    Site Not Available

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510
    Poland

    Site Not Available

  • Medica pro Familia Sp z o.o. S.K.A

    Krakow, 30002
    Poland

    Site Not Available

  • AI Centrum Medyczne

    Poznan, 61-113
    Poland

    Site Not Available

  • Medica pro Familia Sp z o.o. S.K.A

    Warszawa, 01-868
    Poland

    Site Not Available

  • Rheuma Medicus Zakład Opieki Zdrowotnej

    Warszawa, 02-118
    Poland

    Site Not Available

  • Hospital Infanta Luisa

    Sevilla, Andalucia 41007
    Spain

    Site Not Available

  • Centro de Salud Mental Parc Tauli

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital De Fuenlabrada

    Fuenlabrada, Madrid 28942
    Spain

    Site Not Available

  • Hospital De Basurto

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • 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.

    Calle San Jacinto, 41010
    Spain

    Site Not Available

  • 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.

    La Coruna, 15006
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña, CHUAC

    La Coruña, 15006
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Malaga, 29009
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Valme

    Sevilla, 46014
    Spain

    Site Not Available

  • 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.

    Seville, 41007
    Spain

    Site Not Available

  • Chi-Mei Hospital, Liouying

    Tainan City, Yongkang Dist
    Taiwan

    Site Not Available

  • 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.

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City (r.o.c), 83301
    Taiwan

    Site Not Available

  • 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.

    Kuei Shan Hsiang, 33305
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung City, 40201
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305
    Taiwan

    Site Not Available

  • Basildon and Thurrock University Hospital

    Basildon, Essex SS16 5NL
    United Kingdom

    Site Not Available

  • King George Hospital

    Goodmayes, Essex IG7 4DY
    United Kingdom

    Site Not Available

  • Princess Alexandra Hospital

    Harlow, Essex CM20 1QX
    United Kingdom

    Site Not Available

  • Whipps Cross University Hospital

    London, Surrey E11 1NR
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, West Midlands WV10 0QP
    United Kingdom

    Site Not Available

  • Chapel Allerton Hospital

    Leeds, West Yorkshire LS7 4SA
    United Kingdom

    Site Not Available

  • 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.

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • 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.

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • 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.

    Stevenage, SG1 4AB
    United Kingdom

    Site Not Available

  • 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.

    Westcliff On Sea, 5S0 0RY
    United Kingdom

    Site Not Available

  • Rheumatology Associates PC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research

    Glendale, Arizona 85304
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Office: Dr Robin K Dore

    Anaheim, California 92801
    United States

    Site Not Available

  • University of California - San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • Purushotham & Akther Kotha MD Inc

    La Mesa, California 91942
    United States

    Site Not Available

  • Stanford University Hospital

    Palo Alto, California 94304
    United States

    Site Not Available

  • Purushotham & Akther Kotha MD Inc

    San Diego, California 92120
    United States

    Site Not Available

  • East Bay Rheumatology Medical Group

    San Leandro, California 94578
    United States

    Site Not Available

  • Office: Dr Robin K Dore

    Tustin, California 92780
    United States

    Site Not Available

  • Infosphere

    West Hills, California 91307
    United States

    Site Not Available

  • Rheumatology Associates of South Florida

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Jeffrey Alper MD Research

    Naples, Florida 34102
    United States

    Site Not Available

  • Arthritis & Osteoporosis Treatment Center, PA

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Gulf Clinical Research Institute

    Pensacola, Florida 32514
    United States

    Site Not Available

  • Florida Medical Clinic PA

    Zephyrhills, Florida 33542-7505
    United States

    Site Not Available

  • Diagnostic Rheumatology and Research

    Indianapolis, Indiana 46227
    United States

    Site Not Available

  • Physicians Clinic of Iowa

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Heartland Research Associates

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Bluegrass Community Research. Inc

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Johns Hopkins Arthritis Center

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Klein and Associates MD, PA

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Klein and Associates MD, PA

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Beals Institute PC

    Lansing, Michigan 48917
    United States

    Site Not Available

  • North MS Medical Clinics, Inc.

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Glacier View Research Institute

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • New Jersey Physicians

    Clifton, New Jersey 07012
    United States

    Site Not Available

  • Atlantic Coastal Research

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Arthritis, Rheumatic & Back Disease Associates

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Albuquerque Rehabilitation & Rheumatology, PC

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • The Center for Rheumatology

    Albany, New York 12203
    United States

    Site Not Available

  • Weill Cornell Medical College

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Allergy Asthma Immunology of Rochester, AAIR Research Ctr

    Rochester, New York 14618
    United States

    Site Not Available

  • Rheumatology Associates of Long Island

    Smithtown, New York 11787
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Arthritis and Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • PMG Research of Hickory, LLC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Carolina Arthritis Associates

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • STAT Research

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Health Research Institute

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • PMA Medical Specialists, LLC

    Limerick, Pennsylvania 19468
    United States

    Site Not Available

  • Arthritis Group

    Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLC

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Pennsylvania Regional Center for Arthritis & Osteoarthritis

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Methodist Healthcare

    Memphis, Tennessee 38104-3499
    United States

    Site Not Available

  • Ramesh C. Gupta MD

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Austin Regional Clinic

    Austin, Texas 78731
    United States

    Site Not Available

  • Austin Rheumatology Research PA

    Austin, Texas 78705
    United States

    Site Not Available

  • Pioneer Research Solutions

    Cypress, Texas 77429
    United States

    Site Not Available

  • Arthritis Care & Diagnostic Center P.A.

    Dallas, Texas 75231
    United States

    Site Not Available

  • Accurate Clinical Research

    Houston, Texas 77084
    United States

    Site Not Available

  • Houston Institute for Clinical Research

    Houston, Texas 77074
    United States

    Site Not Available

  • Pioneer Research Solutions

    Houston, Texas 77008
    United States

    Site Not Available

  • Accurate Clinical Research

    League City, Texas 77573
    United States

    Site Not Available

  • Arthritis & Osteoporosis Associates LLP

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Accurate Clinical Research

    Nassau Bay, Texas 77058
    United States

    Site Not Available

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • Kadlec Clinic Rheumatology

    Kennewick, Washington 99336
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Arthritis Northwest PLLC

    Spokane, Washington 99204
    United States

    Site Not Available

  • Mountain State Clincial Research

    Clarksburg, West Virginia 26301
    United States

    Site Not Available

  • Rheumatology and Immunotherapy Center

    Franklin, Wisconsin 53132
    United States

    Site Not Available

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