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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

530

Study ID:

NCT03482011

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 69 Locations for this study

See Locations Near You

Univ of Connecticut
Farmington Connecticut, 06032, United States
Florida Academic Dermatology Centers
Coral Gables Florida, 33134, United States
Renstar Medical Research
Ocala Florida, 34470, United States
Forward Clinical Trials, Inc
Tampa Florida, 33624, United States
Arlington Dermatology
Rolling Meadows Illinois, 60008, United States
The South Bend Clinic
South Bend Indiana, 46617, United States
Oregon Medical Research Center
Portland Oregon, 97223, United States
Dermatology and Skin Surgery Center
Exton Pennsylvania, 19341, United States
University of Utah MidValley Dematology
Murray Utah, 84107, United States
Multicare Health System
Tacoma Washington, 98405, United States
Gemeinschaftspraxis Mahlow
Mahlow Brandenburg, 15831, Germany
Universitätsklinikum Münster
Münster Nordrhein-Westfalen, 48149, Germany
Praxis Gerlach
Dresden Sachsen, 01097, Germany
Charité Universitätsmedizin Berlin
Berlin , 10117, Germany
ISA GmbH
Berlin , 10789, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg , 20246, Germany
Clinical Research Hamburg GmbH
Hamburg , 22143, Germany
Toho University School of Medicine, Sakura Hospital
Sakura Chiba, 285-8, Japan
Takagi Dermatological Clinic
Obihiro Hokkaido, 080-0, Japan
Kanto Rosai Hospital
Kawasaki Kanagawa, 211-8, Japan
Yokohama City University Hospital
Yokohama Kanagawa, 236-0, Japan
Ryukyu University Hospital
Nakagami-gun Okinawa, 903-0, Japan
Kume Clinic
Nishi-ku Sakai-shi Osaka, 593-8, Japan
Shimane University Hospital
Izumo Shimane, 693-8, Japan
Tokyo Medical University Hachioji Medical Center
Hachioji Tokyo, 193-0, Japan
NTT Medical Center Tokyo
Shinagawa-KU Tokyo, 141-8, Japan
Tokyo Medical University Hospital
Shinjuku-ku Tokyo, 160-0, Japan
Seibo Hospital
Shinjuku-ku Tokyo, 161-8, Japan
Shirasaki Clinic
Takaoka-shi Toyama, 93308, Japan
Bucheon St. Mary's Hospital
Bucheon, Gyeonggi-do, 14647, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Bundang CHA General Hospital
Sungnam-si Gyeonggi-do, 13496, Korea, Republic of
Ajou University Hospital
Suwon Gyeonggi-do, 16499, Korea, Republic of
Kyung Hee University Hospital
Seoul Korea, 02447, Korea, Republic of
Korea University Guro Hospital
Seoul Korea, 08308, Korea, Republic of
Ulsan University Hospital
Ulsan Korea, 44033, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Hanyang University Medical Center
Seoul , 04763, Korea, Republic of
Konkuk University Hospital
Seoul , 05030, Korea, Republic of
Centro Medico del Angel S.C.
Mexicali Baja California, 21100, Mexico
Hospital de Jesus
Mexico City Distrito Federal, 06090, Mexico
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan Jalisco, 45190, Mexico
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
Morella Michoacan, 58249, Mexico
B&B Investigaciones Medicas, SC
Mazatlan Sinaloa, 82140, Mexico
Kohler Milstein Research, S.A. de C.V.
Merida Yucatan, 97070, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal , 3100, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango , 34000, Mexico
NZOZ ZDROWIE Osteo-Medic
Bialystok , 15-35, Poland
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz , 90-26, Poland
Lubelskie Centrum Diagnostyczne
Swidnik , 21-04, Poland
Centrum Medyczne AMED
Warszawa , 01-51, Poland
DermMEDICA Sp. z o.o.
Wroclaw , 51-31, Poland
Office of Dr. Alma M. Cruz
Carolina , 00985, Puerto Rico
GCM Medical Group PSC
San Juan , 00909, Puerto Rico
GBUZ Clinical dermatology and venereological dispensary
Krasnodar , 35000, Russian Federation
State scientific centre for dermatovenerology and cosmetolog
Moscow , 10707, Russian Federation
First Moscow State Medical University n.a. Sechenov
Moscow , 11999, Russian Federation
GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
Smolensk , 21400, Russian Federation
SPb SBHI Skin-venerologic dispensary #10
St. Petersburg , 19402, Russian Federation
Tver State Medical University
Tver , 17010, Russian Federation
National Taiwan University Hospital
Taipei City Zhongzheng District, 100, Taiwan
National Taiwan University Hospital Hsin-Chu
Hsinchu , 30059, Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung , 83301, Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City , 23561, Taiwan
Chung Shan Medical University Hospital
Taichung City , 40201, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan Hsien , 10508, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

530

Study ID:

NCT03482011

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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