Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT03482011
Start Date
April 24 2018
End Date
January 16 2020
Last Update
September 25 2020
Active Locations (69)
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1
Univ of Connecticut
Farmington, Connecticut, United States, 06032
2
Florida Academic Dermatology Centers
Coral Gables, Florida, United States, 33134
3
Renstar Medical Research
Ocala, Florida, United States, 34470
4
Forward Clinical Trials, Inc
Tampa, Florida, United States, 33624