Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 March 2021 |
Main ID: |
NCT03933943 |
Date of registration:
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30/04/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
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Scientific title:
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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 |
Date of first enrolment:
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May 21, 2019 |
Target sample size:
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28 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03933943 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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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) |
Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Intervention(s)
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Drug: LY3361237
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
[Time Frame: Day 1 predose through Day 155]
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PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
[Time Frame: Day 1 predose through Day 155]
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Secondary ID(s)
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I9S-MC-BTAB
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17180
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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