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

Completed · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT02899988

Run by

Eli Lilly and Company

People needed

205

Starts

2016-09-14

Expected to finish

2019-05-08

Last updated by the study team

2020-06-18

Who can join

Age: 18 and older, up to 75. 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% 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.

You may not qualify if…

• 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).

Where it is running

• Renstar Medical Research — Ocala, Florida, United States
• Forward Clinical Trials, Inc — Tampa, Florida, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• The South Bend Clinic — South Bend, Indiana, United States
• DS Research — Louisville, Kentucky, United States
• Dr. Shondra Smith MD — Lake Charles, Louisiana, United States
• Central Dermatology PC — St Louis, Missouri, United States
• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Clinical Partners LLC — Johnston, Rhode Island, United States
• Menter Dermatology Research Institute — Dallas, Texas, United States
• Dermatology Associates — Seattle, Washington, United States
• For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Calgary, Canada
• For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Halifax, Canada
• For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Montreal, Canada
• For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Peterborough, Canada
• For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Richmond Hill, Canada
• For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. — Waterloo, Canada
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Frankfurt am Main, Germany
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Hamburg, Germany
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Mahlow, Germany
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Gifu, Japan
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Kurume, Japan
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Morioka, Japan
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Nagoya, Japan

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