Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
240 participants
INTERVENTIONAL
2020-11-02
2021-05-17
Brief Summary
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Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 17 weeks, including screening.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Mirikizumab - Prefilled Syringe
2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS)
Mirikizumab Prefilled Syringe
Administered SC by prefilled syringe
Mirikizumab - Autoinjector
2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI)
Mirikizumab Autoinjector
Administered SC by autoinjector
Interventions
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Mirikizumab Prefilled Syringe
Administered SC by prefilled syringe
Mirikizumab Autoinjector
Administered SC by autoinjector
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
* Must not have significant allergies to humanized monoclonal antibodies
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Covance Clinical Research Inc
Daytona Beach, Florida, United States
QPS
Springfield, Missouri, United States
Covance Dallas
Dallas, Texas, United States
Covance Clinical Research Inc
Madison, Wisconsin, United States
Countries
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References
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Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Sep 3. doi: 10.1007/s12325-025-03335-z. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I6T-MC-AMBW
Identifier Type: OTHER
Identifier Source: secondary_id
17820
Identifier Type: -
Identifier Source: org_study_id
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