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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2022
• Main ID: NCT03616912
• Date of registration: 01/08/2018
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus BRAVE I
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
• Date of first enrolment: August 2, 2018
• Target sample size: 830
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03616912
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Brazil, China, Croatia, Czechia, Germany, Greece, Hungary, Israel, Mexico, Netherlands, Russian Federation, Switzerland, Taiwan, Ukraine, 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 a clinical diagnosis of SLE at least 24 weeks prior to screening.

- Have documentation of having met at least 4 of 11 Revised Criteria for Classification
of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American
College of Rheumatology (ACR) criteria for classification of SLE prior to
randomization.

- Have a positive antinuclear antibody (ANA) (titer =1:80) and/or a positive
anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith
(anti-Sm) as assessed by a central laboratory during screening.

- Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
score =6 during screening.

- Have a clinical SLEDAI-2K score =4 at randomization.

- Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B
scores during screening.

- Are receiving at least one of the following standard of care medications for SLE:

- A single antimalarial at a stable dose for at least 8 weeks prior to screening

- A single immunosuppressant at a stable dose for at least 8 weeks prior to
screening

- An oral corticosteroid, initiated at least 4 weeks prior to screening, at a
stable dose =40 milligrams/day prednisone (or equivalent) for at least 2 weeks
prior to screening. If the participant is not receiving an antimalarial or
immunosuppressant, the dose of corticosteroid must be =7.5 milligrams/day
prednisone (or equivalent)

Exclusion Criteria:

- Have severe active lupus nephritis.

- Have active central nervous system (CNS) lupus.

- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
endocrine, hematological, neurological, or neuropsychiatric disorders or any other
serious and/or unstable illness that, in the opinion of the investigator, could
constitute an unacceptable risk when taking investigational product or interfere with
the interpretation of data.

- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection.

- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to
screening.



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

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Baricitinib

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (High Dose) [Time Frame: Week 52]

Secondary Outcome(s)

Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score [Time Frame: Baseline, Week 52]

Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [Time Frame: Week 52]

Percentage of Participants Achieving SRI-4 Response (Low Dose) [Time Frame: Week 52]

Change from Baseline in Tender Joint Count [Time Frame: Baseline, Week 52]

Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, ss) [Time Frame: Baseline through Week 16]

Change from Baseline in Prednisone Dose [Time Frame: Baseline, Week 52]

Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [Time Frame: Baseline, Week 52]

Time to First Severe Flare [Time Frame: Baseline to Week 52]

Change from Baseline in Swollen Joint Count [Time Frame: Baseline, Week 52]

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 52]

Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) [Time Frame: Baseline through Week 16]

Secondary ID(s)

2017-005026-37

16676

I4V-MC-JAHZ

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Incyte Corporation