Psoriasis Clinical Trial
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Summary
The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.
Eligibility Criteria
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.
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There are 69 Locations for this study
Farmington Connecticut, 06032, United States
Coral Gables Florida, 33134, United States
Ocala Florida, 34470, United States
Tampa Florida, 33624, United States
Rolling Meadows Illinois, 60008, United States
South Bend Indiana, 46617, United States
Portland Oregon, 97223, United States
Exton Pennsylvania, 19341, United States
Murray Utah, 84107, United States
Tacoma Washington, 98405, United States
Mahlow Brandenburg, 15831, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Dresden Sachsen, 01097, Germany
Berlin , 10117, Germany
Berlin , 10789, Germany
Hamburg , 20246, Germany
Hamburg , 22143, Germany
Sakura Chiba, 285-8, Japan
Obihiro Hokkaido, 080-0, Japan
Kawasaki Kanagawa, 211-8, Japan
Yokohama Kanagawa, 236-0, Japan
Nakagami-gun Okinawa, 903-0, Japan
Nishi-ku Sakai-shi Osaka, 593-8, Japan
Izumo Shimane, 693-8, Japan
Hachioji Tokyo, 193-0, Japan
Shinagawa-KU Tokyo, 141-8, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Shinjuku-ku Tokyo, 161-8, Japan
Takaoka-shi Toyama, 93308, Japan
Bucheon, Gyeonggi-do, 14647, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Sungnam-si Gyeonggi-do, 13496, Korea, Republic of
Suwon Gyeonggi-do, 16499, Korea, Republic of
Seoul Korea, 02447, Korea, Republic of
Seoul Korea, 08308, Korea, Republic of
Ulsan Korea, 44033, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 04763, Korea, Republic of
Seoul , 05030, Korea, Republic of
Mexicali Baja California, 21100, Mexico
Mexico City Distrito Federal, 06090, Mexico
Zapopan Jalisco, 45190, Mexico
Morella Michoacan, 58249, Mexico
Mazatlan Sinaloa, 82140, Mexico
Merida Yucatan, 97070, Mexico
Distrito Federal , 3100, Mexico
Durango , 34000, Mexico
Bialystok , 15-35, Poland
Lodz , 90-26, Poland
Swidnik , 21-04, Poland
Warszawa , 01-51, Poland
Wroclaw , 51-31, Poland
Carolina , 00985, Puerto Rico
San Juan , 00909, Puerto Rico
Krasnodar , 35000, Russian Federation
Moscow , 10707, Russian Federation
Moscow , 11999, Russian Federation
Smolensk , 21400, Russian Federation
St. Petersburg , 19402, Russian Federation
Tver , 17010, Russian Federation
Taipei City Zhongzheng District, 100, Taiwan
Hsinchu , 30059, Taiwan
Kaohsiung , 83301, Taiwan
New Taipei City , 23561, Taiwan
Taichung City , 40201, Taiwan
Tainan , 70403, Taiwan
Taoyuan Hsien , 10508, Taiwan
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