A Safety Study of Mirikizumab (LY3074828)

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Biological: Placebo - IV; Biological: Mirikizumab - SC; Biological: Mirikizumab- IV

• Registration Number: NCT01947933
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug and how the drug affects the body. The study will last about 3 months for each participant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2013-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2023-05-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Results First Posted: 2024-07-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo IV	Placebo - IV	Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)
Mirikizumab SC	Mirikizumab - SC	Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).
Mirikizumab IV	Mirikizumab- IV	Participants with psoriasis will receive a single escalating dose of 5 milligram (mg), 20 mg, 60 mg, 120 mg, 200 mg, 350 mg, or 600 mg mirikizumab, IV

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration	Baseline through Week 12	This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828	IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828	IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85

Trial Locations

Locations (1)

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.; 🇨🇦 Montreal, Quebec, Canada