A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 9, 2018
End Date:December 17, 2019
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab
in participants with moderate-to-severe plaque psoriasis.


Inclusion Criteria:

- Have chronic plaque psoriasis based on a diagnosis for at least 6 months before
baseline as determined by the investigator.

- Are a candidate for phototherapy and/or systemic therapy.

- Have both an sPGA score of ≥3 and a PASI score ≥12 at screening and at baseline.

- Have ≥10% body surface area (BSA) involvement at screening and baseline.

- If a male, agree to use a reliable method of birth control during the study.

- If female, agree to use highly effective method of contraception.

Exclusion Criteria:

- Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.

- Have a history of drug-induced psoriasis.

- Had a clinically significant flare of psoriasis during the 12 weeks before baseline.

- Use of tanning booths for at least 4 weeks before baseline.

- Concurrent or recent use of any biologic agent within the following periods prior to
baseline: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or
alefacept <60 days; golimumab <90 days; rituximab <12 months; secukinumab <5 months;
or any other biologic agent (e.g., ustekinumab) <5 half lives.

- Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab,
risankizumab), or have any condition or contraindication as addressed in the local
labeling for guselkumab that would preclude the participant from participating in this
protocol.

- Have previously completed or withdrawn from this study, participated in any other
study with ixekizumab or guselkumab, have participated in any study investigating
other IL-17 or IL-23p19 antagonists, or have received treatment with ixekizumab.

- Have previously failed to respond to an IL-17 antagonist, per investigator assessment.

- Have had a live vaccination within 12 weeks of baseline.

- Have a known allergy or hypersensitivity to any biologic therapy.

- Have had any major surgery within 8 weeks of baseline.

- Have had a serious infection, have been hospitalized, or have received intravenous
antibiotics for an infection within 12 weeks of baseline.

- Are women who are pregnant, or who are lactating (breast-feeding).
We found this trial at
101
sites
Dallas, Texas 75230
Principal Investigator: William Abramovits
Phone: 972-661-2729
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Principal Investigator: Bruce G. Rankin
Phone: 386-740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
760
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Boni Elizabeth Elewski
Phone: 2055029960
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
Principal Investigator: Jerry Bagel
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Rawan H Jumean
Phone: 305-631-6704
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911 Park Avenue
New York, New York 10075
212-710-9855
Principal Investigator: Neil S Sadick
Phone: 212-772-7242
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Norfolk, Virginia 23507
Principal Investigator: Abby VanVoorhees
Phone: 757-446-5629
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Ashley N Bassford Cauthen
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
Principal Investigator: Steven Andrew Davis
Phone: 2106921382
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
Principal Investigator: Mark S Lee
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819 E 1st St # 6
Sanford, Florida 32771
Principal Investigator: Rion Forconi
Phone: 407-878-5830
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Alpharetta, Georgia 30022
Principal Investigator: Tiffani K Hamilton
Phone: 770-360-8881
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Ann Arbor, Michigan 48103
Principal Investigator: David Paul Fivenson
Phone: 7342229630
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Arlington, Texas 76011
Principal Investigator: Angela Y Moore
Phone: 817-795-7546
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Austin, Texas 78660
Principal Investigator: Aron Jeffrey Gewirtzman
Phone: 5124543781
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Bakersfield, California 99309
Principal Investigator: Jeffrey James Crowley
Phone: 6613273756
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Bay City, Michigan 48706
Principal Investigator: Brent Boyce
Phone: 989-895-9100
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6565 West Loop South Freeway
Bellaire, Texas 77401
Principal Investigator: Craig Teller
Phone: 832-553-2318
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Beverly, Massachusetts 01915
Principal Investigator: David S Greenstein
Phone: 978-969-6897
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Beverly Hills, California 90211
Principal Investigator: Paul Wallace
Phone: 310-652-8460
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Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas
Phone: 614-947-1716
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Birmingham, Alabama 35205
Principal Investigator: James Krell
Phone: 205-380-6148
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Calgary, Alberta
Principal Investigator: Kirk Allen Barber
Phone: 4032995821
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Charleston, South Carolina 29414
Principal Investigator: Todd Schlesinger
Phone: 843-556-8886
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5815 Blakeney Park Drive
Charlotte, North Carolina 28277
Principal Investigator: Patrick McElgunn
Phone: 704-527-6672
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Clarkston, Michigan 48346
Principal Investigator: Wendy McFalda
Phone: 248-620-3376
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Cleveland, Ohio 44012
Principal Investigator: Neil J Korman
Phone: 216-844-5197
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Coral Gables, Florida 33134
Principal Investigator: Francisco A Kerdel
Phone: 305-324-2110
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Dallas, Texas 75231
Principal Investigator: Jennifer A Cather
Phone: 214-361-2008
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Detroit, Michigan 48202
Principal Investigator: Linda Stein-Gold
Phone: 313-916-8847
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Encinitas, California 92024
Principal Investigator: Stacy R. Smith
Phone: 760-203-3839
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Evansville, Indiana 47715
Principal Investigator: Charles P Hudson
Phone: 812-474-1234
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Exton, Pennsylvania 19341
Principal Investigator: Scott L Gottlieb
Phone: 610-594-6660
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3640 Colonel Glenn Highway
Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers
Phone: 937-775-2463
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Forest Hills, New York 11375
Principal Investigator: Jeffrey Weinberg
Phone: 718-459-0900
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Fort Smith, Arkansas 72916
Principal Investigator: Sandra Johnson
Phone: 479-649-3376
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17271 Brookhurst Street
Fountain Valley, California 92708
Principal Investigator: Vivian Laquer
Phone: 714-531-2966
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Fremont, California 94538
Principal Investigator: Sunil S Dhawan
Phone: 510-797-4111
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920 North Hamilton Road
Gahanna, Ohio 43230
Principal Investigator: Jessica Kaffenberger
Phone: 614-366-9201
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High Point, North Carolina 27262
Principal Investigator: Zoe Diana D Draelos
Phone: 336-841-2040
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Houston, Texas 77030
Principal Investigator: Stephen K. Tyring
Phone: 713-528-8818
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Houston, Texas 77056
Principal Investigator: Suzanne Bruce
Phone: 713-985-0210
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Indianapolis, Indiana 46256
Principal Investigator: Scott A Fretzin
Phone: 317-516-5030
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Johnston, Rhode Island 02919
Principal Investigator: Ellen H Frankel
Phone: 401-454-3800
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2919 West Swann Avenue
Largo, Florida 33770
Principal Investigator: Matthew Zook
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Las Vegas, Nevada 89106
Principal Investigator: Constance Brown
Phone: 702-889-0061
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Los Alamitos, California 90720
Principal Investigator: Lani Clark
Phone: 714-999-6688
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Los Angeles, California 90036
Principal Investigator: Lydie Hazan
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Louisville, Kentucky 40202
Principal Investigator: Cindy E Owen
Phone: 502-585-9059
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Macon, Georgia 31217
Principal Investigator: David J Cohen
Phone: 478-742-2180
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Mason, Ohio 45040
Principal Investigator: Rocco Serrao
Phone: 513-701-5526
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Miami, Florida 33173
Principal Investigator: Jill Waibel
Phone: 305-279-6060
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Kenneth Gordon
Phone: 414-955-3122
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886 Chestnut Ridge Road
Morgantown, West Virginia 26505
Principal Investigator: Rola Gharib
Phone: 304-599-5478
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Murfreesboro, Tennessee 37130
Principal Investigator: Christine Feser
Phone: 615-410-3460
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243 6100 South
Murray, Utah 84107
Principal Investigator: Kristina Callis-Duffin
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New Albany, Indiana 47150
Principal Investigator: Meghan Landis
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New Port Richey, Florida 34652
Principal Investigator: Cathy Barnes
Phone: 727-849-4131
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Newport Beach, California 92660
Principal Investigator: Navid Nami
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Norfolk, Virginia 23507
Principal Investigator: David M Pariser
Phone: 757-622-6315
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Norfolk, Virginia 23502
Principal Investigator: Brian Johnson
Phone: 757-455-5009
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18546 Roscoe Boulevard
Northridge, California 91324
Principal Investigator: Lawrence Osman
Phone: 818-885-0455
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Ocoee, Florida 34761
Principal Investigator: Kelly Taylor
Phone: 407-654-2724
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Orange Park, Florida 32073
Principal Investigator: George Schmieder
Phone: 904-458-0411
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Overland Park, Kansas 66215
Principal Investigator: Mark A McCune
Phone: 913-541-3230
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Owensboro, Kentucky 42303
Principal Investigator: Artis P Truett
Phone: 270-685-4589
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Anthony Gaspari
Phone: 215-955-9555
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85032
Principal Investigator: Sadra Sasha Jazayeri
Phone: 6029710268
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Laura K Ferris
Phone: 412-647-2013
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plainfield, Indiana 46168
Principal Investigator: Scott T Guenthner
Phone: 317-837-6082
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Portland, Oregon 97223
Principal Investigator: Andrew Blauvelt
Phone: 503-245-1525
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Portsmouth, New Hampshire 03801
Principal Investigator: Abel Jarell
Phone: 603-319-8863
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Richmond, Virginia 23294
Principal Investigator: John K Scott
Phone: 804-672-2295
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Rockville, Maryland 20850
Principal Investigator: Lawrence Green
Phone: 301-610-0663
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Rocky Mount, North Carolina 27804
Principal Investigator: Jeffery M Suchniak
Phone: 252-937-0484
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5301 Keystone Court
Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
Phone: 847-392-5440
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Sacramento, California 95831
Principal Investigator: Douglas Young
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Saint Joseph, Michigan 49038
Principal Investigator: Vassilios A Dimitropoulos
Phone: 269-428-5199
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Saint Louis, Missouri 63117
Principal Investigator: Craig L Leonardi
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San Antonio, Texas 78249
Principal Investigator: Stephen L Miller
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San Diego, California 92108
Principal Investigator: Dane M. Shipp
Phone: 619-521-2830
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San Diego, California 92123
Principal Investigator: Walter K Nahm
Phone: 858-278-8470
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San Diego, California 92103
Principal Investigator: Darren A. Farnesi
Phone: 714-999-6688
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San Francisco, California 94132
Principal Investigator: Lawrence Cheung
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Santa Ana, California 92701
Principal Investigator: Jennifer Soung
Phone: 714-547-5151
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Santa Monica, California 90404
Principal Investigator: Paul S Yamauchi
Phone: 310-828-8887
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1821 Wilshire Boulevard
Santa Monica, California 90403
Principal Investigator: Vandana Madkan
Phone: 310-453-3101
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Scottsdale, Arizona 85254
Principal Investigator: Gary McCracken
Phone: 480-471-6132
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Seattle, Washington 98101
Principal Investigator: Peter J Jenkin
Phone: 206-315-0377
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4 Corporate Drive
Shelton, Connecticut 06484
Principal Investigator: Loyd Godwin
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Sherman Oaks, California 91403
Principal Investigator: Shahram Jacobs
Phone: 818-981-1555
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
Principal Investigator: Holly Hake Harris
Phone: 574-204-6432
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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Tampa, Florida 33609
Principal Investigator: Kelley W Yokum
Phone: 813-849-5566
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Tampa, Florida 33609
Principal Investigator: Scott Miller
Phone: 813-948-7550
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Tampa, Florida 33624
Principal Investigator: Seth B Forman
Phone: 813-960-2400
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Walnut Creek, California 94589
Principal Investigator: M. Christine Lee
Phone: 908-941-2273
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West Des Moines, Iowa 50265
Principal Investigator: James A Coggi
Phone: 515-327-4782
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Wheaton, Illinois 60189
Principal Investigator: James J Herrmann
Phone: 630-871-6690
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Principal Investigator: James E Appel
Phone: 910-799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Winston-Salem, North Carolina 27157
Principal Investigator: Steven R Feldman
Phone: 336-716-7740
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Yardley, Pennsylvania 19067
Principal Investigator: Richard G Fried
Phone: 215-579-6155
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