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Janus Kinase (JAK) Inhibitor
Baricitinib for Lupus (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
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 134
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 134
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 moreSecondary 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 moreSide effects data
From 2015 Phase 3 trial • 1307 Patients • NCT017103588%
Nasopharyngitis
4%
Urinary tract infection
4%
Bronchitis
3%
Upper respiratory tract infection
3%
Blood creatine phosphokinase increased
3%
Hypercholesterolaemia
3%
Headache
3%
Nausea
3%
Anaemia
2%
Diarrhoea
2%
Dyspepsia
2%
Influenza
2%
Pharyngitis
2%
Alanine aminotransferase increased
2%
Hyperlipidaemia
2%
Back pain
2%
Hypertension
1%
Rheumatoid arthritis
1%
Rash
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Baricitinib Treatment A
BaricitinibTreatment B
Placebo Follow-up
Baricitinib Follow-up
Adalimumab Treatment A
Placebo Treatment B
Adalimumab Treatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue
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
~9510
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,220,497 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
55,905 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
416,943 Total Patients Enrolled
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