A Study of LY2127399 in Participants With Systemic Lupus Erythematosus



Status:Completed
Conditions:Lupus, Infectious Disease, Orthopedic, Endocrine
Therapuetic Areas:Endocrinology, Immunology / Infectious Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:7/19/2018
Start Date:January 2011
End Date:March 2015

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two
different doses of LY2127399 administered in addition to standard of care therapy in
participants with active SLE.


Inclusion Criteria:

- Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR)
criteria

- Have positive antinuclear antibodies (ANA)

- Agree not to become pregnant throughout the course of the trial

- Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting
all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

Exclusion Criteria:

- Have active severe Lupus kidney disease

- Have active Central Nervous System or peripheral neurologic disease

- Have received intravenous immunoglobulin (IVIg) within 180 days of randomization

- Have active or recent infection within 30 days of screening

- Have had a serious infection within 90 days of randomization

- Have evidence or test positive for Hepatitis B

- Have Hepatitis C

- Are human immunodeficiency virus (HIV) positive

- Have evidence of active or latent tuberculosis (TB)

- Presence of significant laboratory abnormalities at screening

- Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or
basal cell or squamous epithelial skin cell that were completely resected with no
reoccurrence in the 3 yrs prior to randomization

- Have received greater than 40 mgs of prednisone or equivalent in the past 30 days

- Have changed your dose of antimalarial drug in the past 30 days

- Have changed your dose of immunosuppressive drug in the past 90 days

- Have previously received rituximab
We found this trial at
88
sites
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Anniston, AL
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
?
mi
from
Clarksburg, WV
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Cookeville, TN
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Cumberland, MD
Click here to add this to my saved trials
?
mi
from
Debary, FL
Click here to add this to my saved trials
?
mi
from
Duluth, GA
Click here to add this to my saved trials
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
?
mi
from
Escondido, CA
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Granger, IN
Click here to add this to my saved trials
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Lakewood, CA
Click here to add this to my saved trials
?
mi
from
Las Cruces, NM
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lithonia, GA
Click here to add this to my saved trials
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
?
mi
from
Malvern, AR
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Nashua, NH
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Nassau Bay, TX
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
?
mi
from
Plainview, NY
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Portland, ME
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
?
mi
from
Rockford, IL
Click here to add this to my saved trials
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
?
mi
from
Roslyn, NY
Click here to add this to my saved trials
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
?
mi
from
Saint Clair Shores, MI
Click here to add this to my saved trials
?
mi
from
Saint George, UT
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Gabriel, CA
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
South Miami, FL
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
St Leonards, New South Wales 2065
?
mi
from
St Leonards,
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Van Nuys, CA
Click here to add this to my saved trials
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials
?
mi
from
Victoria, TX
Click here to add this to my saved trials
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
Westlake Village, California 91361
?
mi
from
Westlake Village, CA
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials