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

Lilly

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02708095

16270

I4V-MC-JAHH (Other Identifier)

2015-004404-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 3 patient groups, including a placebo group

2 mg Baricitinib

Experimental group

Description:

Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.

Treatment:

Drug: Baricitinib

4 mg Baricitinib

Experimental group

Description:

Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.

Treatment:

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

Participants received Placebo orally once daily (QD) for 24 weeks.

Treatment:

Drug: Placebo