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Janus Kinase (JAK) Inhibitor

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 134
Awards & highlights
Pivotal Trial

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).

Eligible Conditions
  • Lupus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 134
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 134 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Percentage of Participants With Permanent Investigational Product Discontinuations
Percentage of Participants With Serious Adverse Events (SAEs)
+2 more
Secondary study objectives
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
Change From Baseline in Prednisone Dose
Change From Baseline in Swollen Joint Count
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo to 4 mg BaricitinibExperimental Treatment2 Interventions
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Group II: Placebo to 2 mg BaricitinibExperimental Treatment2 Interventions
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
Group III: 4 mg BaricitinibExperimental Treatment2 Interventions
Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
Group IV: 2 mg BaricitinibExperimental Treatment2 Interventions
Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9020
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,465,237 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
62,697 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
427,694 Total Patients Enrolled
~181 spots leftby Jan 2026
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