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

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT03616964

Run by

Eli Lilly and Company

People needed

778

Starts

2018-08-02

Expected to finish

2021-10-20

Last updated by the study team

2022-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Arizona Arthritis & Rheumatology Research — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Associates, P. C. — Tucson, Arizona, United States
• Wallace Rheumatic Studies Center — Beverly Hills, California, United States
• Medvin Clinical Research - Weidmann — Covina, California, United States
• Office: Dr Robin K Dore — Tustin, California, United States
• Inland Rheumatology & Osteoporosis Medical Group — Upland, California, United States
• Denver Arthritis Clinic - Lowry — Denver, Colorado, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Tampa Medical Group, P.A. — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• North Georgia Rheumatology, PC — Lawrenceville, Georgia, United States
• Arthritis Center of Lexington — Lexington, Kentucky, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Advanced Rheumatology, PC — Lansing, Michigan, United States
• Glacier View Research Institute - Endocrinology — Kalispell, Montana, United States
• Innovative Health Research — Las Vegas, Nevada, United States
• Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
• Arthritis and Osteoporosis Associates of New Mexico — Las Cruces, New Mexico, United States
• St. Lawrence Health System — Canton, New York, United States
• New York University Medical Center — New York, New York, United States
• University of Arizona Arthritis Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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