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

• Status: Completed
• Trial end date: 2019-05-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mirikizumab

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% 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.

Exclusion Criteria:

• 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).