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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

NCT01196091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1164

Last updated 2018-06-12

Study results available
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Summary

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.

Conditions

Interventions

DRUG

LY2127399

120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.

DRUG

Placebo every 2 weeks

Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose

DRUG

Placebo every 4 weeks

Administered via subcutaneous injection for 52 weeks.

DRUG

Standard of Care

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-07-31
Completion
2015-06-30

Countries

  • United States
  • Argentina
  • Austria
  • Belarus
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Egypt
  • Germany
  • Guatemala
  • Italy
  • Japan
  • North Macedonia
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Singapore
  • South Korea
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01196091 on ClinicalTrials.gov