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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.

Key facts

Study ID

NCT02708095

Run by

Eli Lilly and Company

People needed

314

Starts

2016-03-24

Expected to finish

2017-11-09

Last updated by the study team

2018-11-21

Who can join

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

You may qualify if…

• Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
• Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
• Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
• Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

You may not qualify if…

• Have active severe lupus nephritis.
• Have active severe 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.
• Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
• Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
• Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
• Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
• Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Where it is running

• Wallace Rheumatic Study Center — Beverly Hills, California, United States
• Medvin Clinical Research — Covina, California, United States
• TriWest Research Assocaites — El Cajon, California, United States
• University of California — La Jolla, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Inlande Rheumatology Clinical Trials — Upland, California, United States
• Denver Arthritis Center — Denver, Colorado, United States
• New Horizon Research Center — Miami, Florida, United States
• West Broward Rheumatology Associates, Inc — Tamarac, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• Kansas City Internal Medicine Research — Overland Park, Kansas, United States
• The Arthritis & Diabetes Clinic Inc. — Monroe, Louisiana, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Clayton Medical Research — St Louis, Missouri, United States
• Arthritis Consultants — St Louis, Missouri, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• North Shore University Hospital at Great Neck — Great Neck, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Paramount Medical Research — Middleburg Heights, Ohio, United States
• Arthritis & Rheumatology Center of Oklahoma PLLC — Oklahoma City, Oklahoma, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• The Oklahoma Center For Arthritis Therapy — Tulsa, Oklahoma, United States
• East Penn Rheumatology — Bethlehem, Pennsylvania, United States
• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.