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Clinical trial

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (BRAVE I)

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Last updated:19th Jan 2021
Status: Recruiting
Identifier: NCT03616912
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (BRAVE I)


The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 809 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Actual Study Start Date: August 2, 2018
Estimated Primary Completion Date: October 30, 2021
Estimated Study Completion Date: November 30, 2021

Arms:
- Experimental: Baricitinib High Dose
- Experimental: Baricitinib Low Dose
- Placebo Comparator: Placebo


Category Value
Study type(s) Interventional
Expected enrolment 809
Actual Study start date 02 August 2018
Estimated Study Completion Date 30 November 2021

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