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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Clinicaltrials.gov identifier NCT03933943

Recruitment Status Completed

First Posted May 1, 2019

Last update posted March 4, 2021

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.

  • Condition or Disease:Lupus Erythematosus, Systemic
  • Intervention/Treatment: Drug: LY3361237
    Drug: Placebo
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: February 2021
  • Actual Study Completion Date: February 2021
Arms and interventions
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
  • 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
  • Ages Eligible for Study: 18 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
Contacts
Locations

United States, Alabama
Pinnacle Research Group
Anniston

United States, Florida
Clinical Research of West Florida
Clearwater

United States, Florida
Clinical Research of West Florida
Tampa

United States, Georgia
North Georgia Rheumatology, PC
Lawrenceville

United States, North Carolina
DJL Clinical Research, PLLC
Charlotte

United States, Ohio
Paramount Medical Research
Middleburg Heights

United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville

United States, Tennessee
West Tennessee Research Institute
Jackson

United States, Texas
Accurate Clinical Management LLC - Katy
Houston

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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
  • Responsible Party: Eli Lilly and Company
  • ClinicalTrials.gov Identifier: NCT03933943 History of Changes
  • Other Study ID Numbers: 17180, I9S-MC-BTAB
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: March 4, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic