A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:12/6/2018
Start Date:September 14, 2016
End Date:May 26, 2019

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A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in
participants with moderate to severe plaque psoriasis.


Inclusion Criteria:

- Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of
chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the
following criteria:

- plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score
≥12 in affected skin at screening and baseline

- sPGA score of ≥3 at screening and baseline

- Candidate for biologic treatment for psoriasis.

Exclusion Criteria:

- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
endocrine, hematological, neurological, or neuropsychiatric disorders or any other
serious and/or unstable illness that, in the opinion of the investigator, could
constitute a risk when taking investigational product or could interfere with the
interpretation of data.

- Breastfeeding or nursing (lactating) women.

- Have had serious, opportunistic, or chronic/recurring infection within 6 months prior
to screening.

- Have received live vaccine(s) (included attenuated live vaccines) within 1 month of
screening or intend to during the study.

- Have any other skin conditions (excluding psoriasis) that would affect interpretation
of the results.

- Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days
prior to baseline.

- Have received topical psoriasis treatment within 14 days prior to baseline.

- Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17
targeting biologics within 8 weeks prior to baseline.

- Have previous exposure to any biologic therapy targeting IL-23 (including
ustekinumab), either licensed or investigational (previous briakinumab use is
permitted).
We found this trial at
13
sites
Plainfield, Indiana 46168
Principal Investigator: Scott Guenthner
Phone: 317-837-6082
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
Principal Investigator: Jerry Bagel
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East Windsor, NJ
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Ashley Bassford Cauthen
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Calgary,
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Dallas, Texas 75246
Principal Investigator: Alan Menter
Phone: 214-820-9114
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Johnston, Rhode Island 02919
Principal Investigator: Ellen Frankel
Phone: 401-454-3800
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Johnston, RI
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Lake Charles, Louisiana 70605
Principal Investigator: Shondra Smith
Phone: 337-477-0011
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Lake Charles, LA
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Louisville, Kentucky 40202
Principal Investigator: Joseph Fowler
Phone: 502-583-7546
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Louisville, KY
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Portland, Oregon 97210
Principal Investigator: Phoebe Rich
Phone: 503-226-3376
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Portland, OR
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Saint Louis, Missouri 63117
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Saint Louis, MO
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Seattle, Washington 98101
Principal Investigator: Peter Jenkin
Phone: 206-315-0377
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Seattle, WA
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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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South Bend, IN
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Tampa, Florida 33624
Principal Investigator: Seth Forman
Phone: 813-264-2155
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Tampa, FL
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