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)

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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
Trumbull, Connecticut 06611
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Albuquerque, New Mexico
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Austin, Texas 78745
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Baton Rouge, Louisiana 70809
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8750 Wilshire Boulevard
Beverly Hills, California 90211
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Boca Raton, Florida
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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...
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Brandon, Florida 33511
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Buenos Aires,
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Buenos Aires,
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80 New York 310
Canton, New York 13617
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Cincinnati, OH
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Columbus, OH
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Fairway, KS
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Houston, TX
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Huntington Beach, California 92646
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Idaho Falls, Idaho 83404
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Los Alamitos, California 90720
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Manhasset, NY
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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...
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10208 Cerny Street
Raleigh, North Carolina 27617
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1340 Wonder World Drive
San Marcos, Texas 78666
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5115 North Armenia Avenue
Tampa, Florida 33603
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3500 Lomita Boulevard
Torrance, California 90505
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Tucson, AZ
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