A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus

The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The study will last up to 26 weeks and may include up to 17 visits to the study center.

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Placebo; Drug: LY3361237

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • North Georgia Rheumatology, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research, PLLC
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
  • Texas
    • Houston, Texas, United States, 77084
      • Accurate Clinical Management LLC - Katy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must have received a diagnosis of SLE at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised American College of Rheumatology [ACR] classification)
• If a participant is taking oral prednisone (or prednisone equivalent) for SLE, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks

• If a participant is taking any of the following medications for SLE, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks:

  • Azathioprine ≤200 mg/day
  • Antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine)
  • Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 grams per day (g/day)
  • Oral, SC, or intramuscular methotrexate ≤15 milligrams per week (mg/week)

Exclusion Criteria:

• Participants must not have a history of, or current, inflammatory joint or skin disease other than SLE
• Participants must not have a current active bacterial, viral, or fungal infection
• Participants must not have evidence of significant liver or kidney dysfunction
• Participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months.
• Participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months
• Participants must not have received blood products (e.g., blood transfusion, platelets, etc.) within the last 12 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered SC	Drug: Placebo; Administered SC
Experimental: LY3361237; LY3361237 administered subcutaneously (SC)	Drug: LY3361237; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 155

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237	PK: Cmax of LY3361237	Day 1 predose through Day 155
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237	PK: AUC Over the Dosing Interval of LY3361237	Day 1 predose through Day 155

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 17180; I9S-MC-BTAB (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