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- Have previously completed or withdrawn from this study, participated in any other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
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Walnut Creek, California 94589
Principal Investigator: M. Christine Lee
Phone: 908-941-2273
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Principal Investigator: Bruce G. Rankin
Phone: 386-740-0770
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Boni Elizabeth Elewski
Phone: 2055029960
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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
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Phone: 2106921382
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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819 E 1st St # 6
Sanford, Florida 32771
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Alpharetta, Georgia 30022
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Ann Arbor, Michigan 48103
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Arlington, Texas 76011
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Bakersfield, California 99309
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Bay City, Michigan 48706
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6565 West Loop South Freeway
Bellaire, Texas 77401
Principal Investigator: Craig Teller
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Beverly, Massachusetts 01915
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Beverly Hills, California 90211
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Birmingham, Alabama 35205
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Calgary, Alberta
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Charleston, South Carolina 29414
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5815 Blakeney Park Drive
Charlotte, North Carolina 28277
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Clarkston, Michigan 48346
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Coral Gables, Florida 33134
Principal Investigator: Francisco A Kerdel
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Principal Investigator: Jennifer A Cather
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Principal Investigator: Linda Stein-Gold
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Exton, Pennsylvania 19341
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3640 Colonel Glenn Highway
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Forest Hills, New York 11375
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Fort Smith, Arkansas 72916
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17271 Brookhurst Street
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920 North Hamilton Road
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Johnston, Rhode Island 02919
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2919 West Swann Avenue
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Macon, Georgia 31217
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Mason, Ohio 45040
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Miami, Florida 33173
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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Phone: 414-955-3122
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886 Chestnut Ridge Road
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Murfreesboro, Tennessee 37130
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243 6100 South
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18546 Roscoe Boulevard
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Ocoee, Florida 34761
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Owensboro, Kentucky 42303
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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Phoenix, Arizona 85032
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Laura K Ferris
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Plainfield, Indiana 46168
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Portland, Oregon 97223
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Portsmouth, New Hampshire 03801
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Richmond, Virginia 23294
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Rockville, Maryland 20850
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Rocky Mount, North Carolina 27804
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5301 Keystone Court
Rolling Meadows, Illinois 60008
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San Diego, California 92103
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Santa Monica, California 90404
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1821 Wilshire Boulevard
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Seattle, Washington 98101
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4 Corporate Drive
Shelton, Connecticut 06484
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Sherman Oaks, California 91403
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
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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
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Tampa, Florida 33609
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Tampa, Florida 33624
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Wheaton, Illinois 60189
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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Winston-Salem, North Carolina 27157
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Yardley, Pennsylvania 19067
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