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



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:August 2015
End Date:August 3, 2017

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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.

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.

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
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Denver, Colorado 80209
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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725 West Granada Blvd
Ormond Beach, Florida 32174
386-898-0547
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque, New Mexico 87106
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
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Atlanta, Georgia 30342
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Austin, Texas 78705
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Beverly, Massachusetts 01915
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Beverly Hills, California 90212
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Birmingham, Alabama 35205
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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Coral Gables, Florida 33134
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Darien, Illinois 60561
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Evansville, Indiana 47713
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Exton, Pennsylvania 19341
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Houston, Texas 77030
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Indianapolis, Indiana 46256
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Johnston, Rhode Island 02919
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Knoxville, Tennessee 37922
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Lake Charles, Louisiana 70605
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Louisville, Kentucky 40202
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Mount Pleasant, South Carolina 29464
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Norfolk, Virginia 23507
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Overland Park, Kansas 66215
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97210
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Portland, Oregon 97223
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Rochester, New York 14623
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Rockville, Maryland 20850
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Sacramento, California 95819
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Salt Lake City, Utah 84132
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Seattle, Washington 98101
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
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Tulsa, Oklahoma 74135
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Webster, Texas 77598
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Wenatchee, Washington 98801
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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Wilmington, North Carolina 28403
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Winston-Salem, North Carolina 27103
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