A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:September 14, 2015
End Date:October 30, 2018

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A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab
compared to placebo in participants with active psoriatic arthritis.


Inclusion Criteria:

- Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6
months, 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 during
the study

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

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

Exclusion Criteria:

- Current or prior use of biologic agents for treatment of Ps or PsA

- Inadequate response to greater than or equal to 4 conventional disease-modifying
antirheumatic drugs (DMARDS)

- Current use of more than one cDMARDs

- Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other
than PsA

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

- Serious disorder or illness other than psoriatic arthritis

- Serious infection within the last 3 months

- Breastfeeding or nursing (lactating) women
We found this trial at
23
sites
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Principal Investigator: Shadi Shahouri
Phone: 316-689-6635
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Brooklyn, New York 11201
Principal Investigator: David Goddard
Phone: 646-962-4650
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Brooklyn, NY
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Cedar Rapids, Iowa 52401
Principal Investigator: Michael Brooks
Phone: 319-398-1546
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Cedar Rapids, IA
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Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-6331
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Cumberland, MD
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Cypress, Texas 77429
Principal Investigator: Asif Cochinwala
Phone: 713-333-9323
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Cypress, TX
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Dallas, Texas 75321
Principal Investigator: Alan Brodsky
Phone: 214-696-1600
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Dallas, TX
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Durham, North Carolina 27704
Principal Investigator: Irene Whitt
Phone: 919-220-5255
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Durham, NC
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Glendale, Arizona 85304
Principal Investigator: Ramina Jajoo
Phone: 480-626-6654
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Glendale, AZ
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
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Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
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Kalispell, MT
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Kennewick, Washington 99336
Principal Investigator: Derek Peacock
Phone: 509-942-2528
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Kennewick, WA
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Mesa, Arizona 85202
Principal Investigator: Paul Caldron
Phone: 480-321-8580
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Mesa, AZ
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Orange Park, Florida 32073
Principal Investigator: Meera Oza
Phone: 904-276-0001
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Phoenix, Arizona 85032
Principal Investigator: Ralph Bennett
Phone: 480-321-8580
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Plovdiv,
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Sacramento, California 95817
Principal Investigator: Siba Raychaudhuri
Phone: 916-473-7000
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San Leandro, California 94578
Principal Investigator: C. Michael Neuwelt
Phone: 510-357-1303
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San Leandro, CA
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Seattle, Washington 98104
Principal Investigator: Philip Mease
Phone: 206-386-2000
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Spokane, Washington 99204
Principal Investigator: Eric Mueller
Phone: 509-838-6500
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Voorhees, New Jersey 08043
Principal Investigator: Sheldon Solomon
Phone: 856-424-5005
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Worcester, Massachusetts 01655
Principal Investigator: Jonathan Kay
Phone: 508-334-6273
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Wyomissing, Pennsylvania 19610
Principal Investigator: Gregory Emkey
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Zephyrhills, Florida 33542
Principal Investigator: David Sikes
Phone: 813-780-8368
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