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

Eli Lilly and Company0 sites825 target enrollmentJanuary 20, 2020

ConditionsSystemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859 Therapeutic area: Diseases [C] - Immune System Diseases [C20]

DrugsOlumiant

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Systemic Lupus Erythematosus (SLE)
Sponsor: Eli Lilly and Company
Enrollment: 825
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 20, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•\-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
•\- Have a history of: recurrent (\= 2\) VTE (DVT/PE); cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly (other than primarily due to SLE); have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \<5 years prior to randomization.