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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933943
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: LY3361237 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : February 15, 2021
Actual Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3361237
LY3361237 administered subcutaneously (SC)
 Drug: LY3361237
Administered SC
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [ Time Frame: 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 :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 [ Time Frame: Day 1 predose through Day 155 ]
    PK: Cmax of LY3361237

  2. PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237 [ Time Frame: Day 1 predose through Day 155 ]
    PK: AUC Over the Dosing Interval of LY3361237


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933943


Locations
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United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Clinical Research of West Florida
Tampa, Florida, United States, 33606
United States, Georgia
North Georgia Rheumatology, PC
Lawrenceville, Georgia, United States, 30046
United States, North Carolina
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28210
United States, Ohio
Paramount Medical Research
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Accurate Clinical Management LLC - Katy
Houston, Texas, United States, 77084
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03933943    
Other Study ID Numbers: 17180
I9S-MC-BTAB ( Other Identifier: Eli Lilly and Company )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases