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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2022
  • participants needed
    809
  • sponsor
    Eli Lilly and Company
Updated on 13 June 2021
corticosteroids
prednisone
immunosuppressive agents
lupus
antinuclear antibody
antimalarials

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).

Details
Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases
Treatment Placebo, Baricitinib
Clinical Study IdentifierNCT03616912
SponsorEli Lilly and Company
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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