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A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT03616912•Eli Lilly and Company

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (184)

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, United States

University of Arizona

Tucson, Arizona, United States

St. Joseph Heritage Medical Group

Fullerton, California, United States

MD Medical Corporation

Hemet, California, United States

ACRC Studies

Poway, California, United States

Office: Hans R Barthel M.D.

Santa Barbara, California, United States

Medvin Clinical Research - Weidmann

Whittier, California, United States

Denver Arthritis Clinic - Lowry

Denver, Colorado, United States

Key Dates

Start Date

August 2, 2018

Primary Completion Date

November 1, 2021

Completion Date

March 9, 2022

Last Updated

January 30, 2023

Enrollment

830

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Baricitinib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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