A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

illy S.A.0 sites300 target enrollmentApril 4, 2016

Overview

No summary available.

Registry

who.int

Start Date

April 4, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

illy S.A.

•\[1] Are at least 18 years of age.
•\[2] Have a positive ANA (HEp\-2 ANA titer ?1:80\) and/or a positive anti\-dsDNA (? 30 IU) as assessed by a central laboratory at screening.
•\[3] Have a SLEDAI\-2K score ?4 based on clinical symptoms (not including lab values) at randomization.
•\[4] Have active arthritis and/or active rash as defined by the SLEDAI\-2K at randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 270
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 30

•\[1] Have active severe lupus nephritis
•\[2] Have active severe central nervous system (CNS) lupus
•\[3] 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 unaccepatable risk when taking investigational product or interfere with the interpretation of data.
•\[4] Have a current or recent (\<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection.
•\[5] Are currently receiving oral corticosteroids at doses \>20\-mg per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
•\[6] Have started treatment with or adjusted the dose of NSAIDs (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 2 weeks of screening or within 4 weeks of planned randomization.
•\[7] Have started treatment with or adjusted the dose of an antimalarial within 10 weeks of screening or within 12 weeks of planned randomization.
•\[8] Have started treatment with or adjusted the dose of an immunosuppressant within 10 weeks of screening or within 12 weeks of planned randomization.
•\[9] Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.