A Study to Evaluate the Efficacy and Safety 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 - Any
Updated:2/17/2019
Start Date:April 24, 2018
End Date:March 19, 2020

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A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-1

The purpose of this study is to evaluate the efficacy and safety of 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% BSA and absolute PASI score ≥12 in affected skin
at screening and baseline

- sPGA score of ≥3 at screening and baseline

- Candidate for systemic therapy and/or phototherapy for psoriasis.

Exclusion Criteria:

- Have an unstable or uncontrolled illness, including but not limited to a
cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, or neurologic disease or abnormal laboratory values at screening, that in
the opinion of the investigator, would potentially affect participant safety within
the study or of interfering with the interpretation of data.

- Breastfeeding or nursing women.

- Have had serious, opportunistic, or chronic/recurring infection within 3 months prior
to screening.

- Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or
received live vaccine(s) (including attenuated live vaccines) within 12 weeks of
baseline or intend to receive either 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 12 weeks prior to baseline.

- Have previous exposure to any biologic therapy targeting IL-23 (including
ustekinumab), either licensed or investigational.
We found this trial at
11
sites
5301 Keystone Court
Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
Phone: 847-392-5440
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Ashley N Bassford Cauthen
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Ocala, FL
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Coral Gables, Florida 33134
Principal Investigator: Francisco A Kerdel
Phone: 305-324-2110
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Coral Gables, FL
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Exton, Pennsylvania 19341
Principal Investigator: Scott L Gottlieb
Phone: 610-594-6660
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Exton, PA
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Farmington, Connecticut 06030
Principal Investigator: Mona Shahriari
Phone: 860-679-4600
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Farmington, CT
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Mahlow, Brandenburg 15831
Principal Investigator: Michael Sebastian
Phone: 49337939423
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Mahlow,
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243 6100 South
Murray, Utah 84107
Principal Investigator: Kristina Callis-Duffin
Phone: 801-581-6465
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Murray, UT
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Portland, Oregon 97223
Principal Investigator: Andrew Blauvelt
Phone: 503-245-1525
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Portland, OR
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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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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: Aaron K Pace
Phone: 253-572-2842
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Tacoma, WA
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Tampa, Florida 33624
Principal Investigator: Seth B Forman
Phone: 813-960-2400
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Tampa, FL
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