A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company0 sites821 target enrollmentMay 3, 2019

Overview

No summary available.

Registry

who.int

Start Date

May 3, 2019

End Date

March 9, 2022

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Type of Patient and Disease Characteristics
•\[1] Are at least 18 years of age.
•\[2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
•\[3] 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 ACR criteria for classification of SLE (Tan et al. 1982; Hochberg et al. 1997\) prior to randomization.
•\[4] Have 1 or more of the following as assessed by the central lab during
•screening: a positive antinuclear antibody (ANA; titer \=1:80\), and/or a positive antidsDNA,
•and/or a positive anti\-Smith (anti\-Sm). Patients with an ANA \<1:80 at
•screening with documentation of a historical ANA \=1:80 may be eligible, as
•assessed by the eligibility review committee.
•Note: The ANA, anti\-dsDNA, and anti\-Smith measurements may be Repeated by the central lab once during the screening period, and the value resulting from repeat testing may be accepted for enrollment eligibility if it meets the eligibility criterion.

•\-Have severe active lupus nephritis defined clinically and/or by histologic evidence of proliferative glomerulonephritis on renal biopsy (if available) within the 24 weeks prior to screening, or urine protein/creatinine ratio \>200 mg/mmol (as an estimate of approximate proteinuria \>2 g/day) or eGFR (Modification of Diet in Renal Disease \[MDRD]) \<40 mL/min/1\.73 m2 at screening, or as determined by the eligibility review committee.
•\-Have active CNS lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by SLEDAI\-2K
•\-Have active fibromyalgia that, in the investigator’s opinion, would make it
•difficult to appropriately assess SLE activity for the purposes of this study.
•\-Have been treated for or had an active occurrence of a systemic inflammatory condition other than SLE such as, but not limited to, RA, juvenile chronic
•arthritis, spondyloarthropathy, Crohn’s disease, ulcerative colitis, or psoriatic arthritis within the 12 weeks prior to screening. Patients with secondary
•Sjögren’s syndrome are not excluded.
•\-Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study
•\-Have screening ECG abnormalities
•\-Have experienced any of the following within 12 weeks of screening: VTE, MI, unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.