A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03933943
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	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)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: LY3361237

LY3361237 administered subcutaneously (SC)

Placebo Comparator: Placebo

Placebo administered SC

Interventions

Drug: - LY3361237

Administered SC

Drug: - Placebo

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pinnacle Research Group, Anniston, Alabama

Status

Completed

Address

Pinnacle Research Group

Anniston, Alabama, 36207

Site Contact

[email protected]

1-317-615-4559

Clinical Research of West Florida, Clearwater, Florida

Status

Active, not recruiting