A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
NCT ID: NCT03933943
Last Updated: 2021-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2019-05-21
2021-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3361237
LY3361237 administered subcutaneously (SC)
LY3361237
Administered SC
Placebo
Placebo administered SC
Placebo
Administered SC
Interventions
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LY3361237
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Related Links
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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
Other Identifiers
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I9S-MC-BTAB
Identifier Type: OTHER
Identifier Source: secondary_id
17180
Identifier Type: -
Identifier Source: org_study_id
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