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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03843125
• Date of registration: 14/02/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) SLE-BRAVE-X
• Scientific title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: September 9, 2019
• Target sample size: 1147
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03843125
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have completed the final treatment study visit of an originating study, such as study
JAHZ (NCT03616912) or Study JAIA (NCT03616964).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: Baricitinib

Primary Outcome(s)

Percentage of Participants With Adverse Events of Special Interest (AESIs) [Time Frame: Week 134]

Percentage of Participants With Permanent Investigational Product Discontinuations [Time Frame: Week 134]

Percentage of Participants With Temporary Investigational Product Interruptions [Time Frame: Week 134]

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Week 134]

Percentage of Participants With Serious Adverse Events (SAEs) [Time Frame: Week 134]

Secondary Outcome(s)

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response [Time Frame: Week 134]

Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score [Time Frame: Baseline through Week 48]

Change From Baseline in Tender Joint Count [Time Frame: Baseline through Week 48]

Change From Baseline in Swollen Joint Count [Time Frame: Baseline trough Week 48]

Change From Baseline in Worst Pain Numeric Rating Scale (NRS) [Time Frame: Baseline through Week 48]

Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate [Time Frame: Baseline through Week 48]

Change From Baseline in Prednisone Dose [Time Frame: Baseline through Week 48]

Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score =10 at Baseline With =50% Reduction in CLASI Total Activity Score [Time Frame: Week 48]

Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [Time Frame: Week 48]

Secondary ID(s)

16832

2017-005028-11

I4V-MC-JAIM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Incyte Corporation

Results

• Results available: Yes
• Date Posted: 16/05/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03843125