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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3361237
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lupus Erythematosus, Systemic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pinnacle Research Group
  • Clinical Research of West Florida
  • Clinical Research of West Florida
  • North Georgia Rheumatology, PC
  • DJL Clinical Research, PLLC
  • Paramount Medical Research
  • Altoona Center For Clinical Research
  • West Tennessee Research Institute
  • Accurate Clinical Management LLC - Katy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3361237

Placebo

Arm Description

LY3361237 administered subcutaneously (SC)

Placebo administered SC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
PK: Cmax of LY3361237
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
PK: AUC Over the Dosing Interval of LY3361237

Full Information

First Posted
April 30, 2019
Last Updated
March 3, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03933943
Brief Title
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 1, 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3361237
Arm Type
Experimental
Arm Description
LY3361237 administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
LY3361237
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Day 155
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
Description
PK: Cmax of LY3361237
Time Frame
Day 1 predose through Day 155
Title
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
Description
PK: AUC Over the Dosing Interval of LY3361237
Time Frame
Day 1 predose through Day 155

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
North Georgia Rheumatology, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Accurate Clinical Management LLC - Katy
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/eiRWT5wAOkRpZOHEo4Ira
Description
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

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