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

• Status: Active, not recruiting
• Trial end date: 2022-06-19
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Incyte Corporation

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.