A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Phase 1

Completed

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: LY3361237; Drug: Placebo

• Registration Number: NCT03933943
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-05-21
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2021-03-01
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3361237	LY3361237	LY3361237 administered subcutaneously (SC)
Placebo	Placebo	Placebo administered SC

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

West Tennessee Research Institute; 🇺🇸 Jackson, Tennessee, United States

Accurate Clinical Management LLC - Katy; 🇺🇸 Houston, Texas, United States

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Clinical Research of West Florida; 🇺🇸 Tampa, Florida, United States

North Georgia Rheumatology, PC; 🇺🇸 Lawrenceville, Georgia, United States

DJL Clinical Research, PLLC; 🇺🇸 Charlotte, North Carolina, United States

Paramount Medical Research; 🇺🇸 Middleburg Heights, Ohio, United States