A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID: NCT03482011
Run by: Eli Lilly and Company
People needed: 530
Starts: 2018-04-24
Expected to finish: 2020-01-16
Last updated by the study team: 2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Florida Academic Dermatology Centers — Coral Gables, Florida, United States
Renstar Medical Research — Ocala, Florida, United States
Forward Clinical Trials, Inc — Tampa, Florida, United States
Arlington Dermatology — Rolling Meadows, Illinois, United States
The South Bend Clinic — South Bend, Indiana, United States
Oregon Medical Research Center — Portland, Oregon, United States
Dermatology and Skin Surgery Center — Exton, Pennsylvania, United States
University of Utah MidValley Dematology — Murray, Utah, United States
Multicare Health System — Tacoma, Washington, United States
Gemeinschaftspraxis Mahlow — Mahlow, Brandenburg, Germany
Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany
Praxis Gerlach — Dresden, Saxony, Germany
Charité Universitätsmedizin Berlin — Berlin, Germany
ISA GmbH — Berlin, Germany
Universitätsklinikum Hamburg - Eppendorf — Hamburg, Germany
Clinical Research Hamburg GmbH — Hamburg, Germany
Toho University School of Medicine, Sakura Hospital — Sakura, Chiba, Japan
Takagi Dermatological Clinic — Obihiro, Hokkaido, Japan
Kanto Rosai Hospital — Kawasaki, Kanagawa, Japan
Yokohama City University Hospital — Yokohama, Kanagawa, Japan
Ryukyu University Hospital — Nakagami-gun, Okinawa, Japan
Kume Clinic — Nishi-ku Sakai-shi, Osaka, Japan
Shimane University Hospital — Izumo, Shimane, Japan
Tokyo Medical University Hachioji Medical Center — Hachiōji, Tokyo, Japan
Univ of Connecticut — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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