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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03933943•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (9)

Pinnacle Research Group

Anniston, Alabama, United States

Clinical Research of West Florida

Clearwater, Florida, 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

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Accurate Clinical Management LLC - Katy

Houston, Texas, United States

Key Dates

Start Date

May 21, 2019

Primary Completion Date

February 15, 2021

Completion Date

February 15, 2021

Last Updated

March 4, 2021

Enrollment

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

LY3361237

DRUG

Placebo

DRUG

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

RECRUITINGPHASE3

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

NCT07438496

Lupus Erythematosus, Systemic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases