A Safety Study of Mirikizumab (LY3074828)

A Phase I, Randomized, Placebo-Controlled Study of LY3074828, an Anti-IL-23 Humanized Antibody

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Placebo - IV; Biological: Mirikizumab- IV; Biological: Mirikizumab - SC

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2J 1C4
      • 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.
  • Quebec
    • Montreal, Quebec, Canada, H2K4L5
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (Psoriasis participants):

• Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline
• Plaque psoriasis involving >2% body surface area (BSA) in affected skin other than the face and scalp at screening and baseline
• Are willing and able to washout topicals for at least 14 days before baseline on the 2 target lesions

Inclusion Criteria (Healthy participants):

• Are overtly healthy males or females, as determined by medical history and physical examination
• Are women not of childbearing potential
• Are between the ages of 18 and 65 years, inclusive, at the time of screening
• Have a body mass index between 18.5 and 32.0 kilogram per square meter (kg/m2), inclusive, and a minimum body weight of 55 kg
• Have clinical laboratory test results within normal reference range for the central laboratory, or results with acceptable deviations that are judged to be not clinically significant by the investigator
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Have given written informed consent approved by Lilly and the ERB governing the site

Exclusion Criteria (Psoriasis and healthy participants):

• Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy). Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval
• Within 28 days prior to baseline: have received systemic nonbiologic psoriasis therapy
• Within 14 days prior to baseline: have received topical psoriasis treatment
• Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data
• Have had clinically significant symptomatic herpes zoster within 3 months of screening
• Show evidence of active or latent tuberculosis (TB)
• Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study
• Have significant allergies to humanized monoclonal antibodies or any components of the mirikizumab product formulation or have a history of significant atopy
• 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 and cervical carcinoma in situ, with no evidence of recurrence within 5 years prior to baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo IV; Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)	Biological: Placebo - IV; Administered IV
Experimental: 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	Biological: Mirikizumab- IV; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab SC; Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).	Biological: Mirikizumab - SC; Administered SC; Other Names: LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration	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.	Baseline through Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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, Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimated): September 23, 2013

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Mirikizumab
• Other Study ID Numbers: 15039; I6T-MC-AMAA (Other Identifier: Eli Lilly and Company)