NCT03933943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2019

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

April 30, 2019

Last Update Submit

March 3, 2021

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline through Day 155

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237

    Day 1 predose through Day 155

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

    Day 1 predose through Day 155

Study Arms (2)

LY3361237

EXPERIMENTAL

LY3361237 administered subcutaneously (SC)

Drug: LY3361237

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3361237DRUG

Administered SC

LY3361237
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33606, United States

Location

North Georgia Rheumatology, PC

Lawrenceville, Georgia, 30046, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28210, United States

Location

Paramount Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Accurate Clinical Management LLC - Katy

Houston, Texas, 77084, United States

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 1, 2019

Study Start

May 21, 2019

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03-01

Data Sharing

IPD Sharing
Will not share

Locations

US(9)