A Safety Study of Mirikizumab (LY3074828)

NCT01947933 | Completed Phase 1 Results

• 2 other identifiers: 15039I6T-MC-AMAA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Placebo IV

PLACEBO COMPARATOR

Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)

Biological: Placebo - IV

Mirikizumab IV

EXPERIMENTAL

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

Mirikizumab SC

EXPERIMENTAL

Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).

Biological: Mirikizumab - SC

Interventions

Mirikizumab- IV BIOLOGICAL

Administered IV

Also known as: LY3074828

Mirikizumab IV

Mirikizumab - SC BIOLOGICAL

Administered SC

Also known as: LY3074828

Mirikizumab SC

Placebo - IV BIOLOGICAL

Administered IV

Placebo IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Waterloo, Ontario, N2J 1C4, Canada

Location

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, H2K4L5, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-02

Locations

CA (2)