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A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

NCT03843125 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1147

Last updated 2023-05-16

Study results available
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Summary

The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

Conditions

Interventions

DRUG

Baricitinib

Administered orally.

DRUG

Placebo

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2022-04-01
Completion
2022-04-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Chile
  • China
  • Colombia
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03843125 on ClinicalTrials.gov