A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants

A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants

The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector.

Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Citrate-Free Mirikizumab

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami
  • Missouri
    • Springfield, Missouri, United States, 65802
      • QPS Missouri
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Type of participant and disease characteristics

1. Overtly healthy males and females as determined by medical evaluation including:

   • Medical history,
   • Physical examination,
   • Clinical laboratory tests,
   • Electrocardiogram (ECG),
   • Vital signs

   Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.

2. Have clinical laboratory test results:

   • Within normal reference range for the population, or
   • Within normal reference range for the investigative site, or
   • Results with acceptable deviations that are judged to be not clinically significant by the investigator.

   Weight

3. Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m^2), inclusive.

   Exclusion Criteria:

   Participants are excluded from the study if any of the following criteria apply:

   Medical conditions

4. Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation.
5. Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
6. Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.

7. Have a diagnosis or history of malignant disease within 5 years prior to baseline.

   Prior/concomitant therapy

8. Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
9. Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing.
10. Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use.

11. Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization.

    Prior/concurrent clinical study experience

12. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
13. Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing.

14. Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab.

    Diagnostic assessments

15. Have a current infection with hepatitis C virus.
16. Have a current infection with hepatitis B virus.
17. Have a current or recent acute, active infection.

18. Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization:

    1. Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both.
    2. Opportunistic: As defined in Winthrop et al. 2015. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
    3. Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer.
    4. Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis.

19. Show evidence of active or latent tuberculosis (TB).

    Other exclusion criteria

20. Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
21. Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions.
22. In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200 mg Mirikizumab (Test); Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	Drug: Citrate-Free Mirikizumab; Administered SC; Other Names: LY3074828
Experimental: 200 mg Mirikizumab (Reference); Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	Drug: Citrate-Free Mirikizumab; Administered SC; Other Names: LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab	Cmax of Mirikizumab is reported.	Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab	AUC [0-∞] of Mirikizumab is reported.	Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab	AUC [0 to tlast] of Mirikizumab is reported.	Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

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

Publications and helpful links

General Publications

• Otani Y, Payne CD, Loftus EV Jr, D'Haens G, Ben Horin S, Upadhya K A, Todd K, Pellanda P, Shi G, Zhang X. One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. Adv Ther. 2025 Nov 28. doi: 10.1007/s12325-025-03422-1. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): December 27, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; mirikizumab
• Other Study ID Numbers: 18852; I6T-MC-AMCB (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No