Status:
TERMINATED
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Lead Sponsor:
Genentech, Inc.
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief Summary
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 Stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03407482
Start Date
January 9 2018
End Date
November 20 2019
Last Update
December 19 2020
Active Locations (53)
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1
Valerius Medical Group
Los Alamitos, California, United States, 90720
2
RASF-Clinical Research Center
Boca Raton, Florida, United States, 33486
3
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States, 33511
4
Clinical Research of West Florida
Clearwater, Florida, United States, 33765