A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933943
• Other study ID #: 17180
• Secondary ID: I9S-MC-BTAB
• Status: Completed
• Phase: Phase 1
• Start date: May 21, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: March 1, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• LY3361237
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Pinnacle Research Group	Anniston	Alabama
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Accurate Clinical Management LLC - Katy	Houston	Texas
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	North Georgia Rheumatology, PC	Lawrenceville	Georgia
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Clinical Research of West Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237	PK: Cmax of LY3361237	Day 1 predose through Day 155
Secondary	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

External Links

•   A Study of LY3361237 in Participants With Systemic Lupus Erythematosus