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- Have previously completed or withdrawn from this study, participated in any other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
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Portland, Oregon 97223
Principal Investigator: Andrew Blauvelt
Phone: 503-245-1525
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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 
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Phone: 2055029960
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
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2128 W Flagler St # 201
Miami, Florida 33144
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911 Park Avenue
New York, New York 10075
212-710-9855
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Norfolk, Virginia 23507
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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7810 Louis Pasteur
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210-692-1382
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4499 Medical Drive
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819 E 1st St # 6
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1020 Walnut St
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200 Lothrop St
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5301 Keystone Court
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211 North Eddy St.
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1907 Tradd Ct
Wilmington, North Carolina 28401
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