An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 76
Updated:4/6/2019
Start Date:January 9, 2018
End Date:April 9, 2020
Contact:Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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

A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term
safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who
have completed Study GA30044 (NCT02908100) up to 48 weeks.


Inclusion Criteria:

- Able to comply with the study protocol, in the investigator's judgment

- Completion of Study GA30044 up to 48 weeks

- Acceptable safety and tolerability during Study GA30044 as determined by the
investigator

Exclusion Criteria:

- Met protocol-defined treatment-stopping criteria during Study GA30044

- An adverse event in Study GA30044 that required permanent discontinuation of study
drug

- In the opinion of the investigator, any new, significant, uncontrolled comorbidity or
new clinical manifestation (related to SLE or not) that requires medications not
allowed in this protocol; or could put the participant at undue risk from a safety
perspective

- Any uncontrolled or clinically significant laboratory abnormality that would affect
safety, interpretation of study data, or the participant's participation in the study
in the opinion of the investigator in consultation with the Medical Monitor
We found this trial at
27
sites
80 New York 310
Canton, New York 13617
?
mi
from
Canton, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
2147 Northeast Coachman Road
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Austin, Texas 78745
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
8750 Wilshire Boulevard
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Boca Raton, Florida
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Buenos Aires,
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Fairway, KS
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Los Alamitos, California 90720
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials
10208 Cerny Street
Raleigh, North Carolina 27617
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
1340 Wonder World Drive
San Marcos, Texas 78666
?
mi
from
San Marcos, TX
Click here to add this to my saved trials
5115 North Armenia Avenue
Tampa, Florida 33603
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3500 Lomita Boulevard
Torrance, California 90505
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Trumbull, Connecticut 06611
?
mi
from
Trumbull, CT
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials