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

• Status: Terminated
• Trial end date: 2019-11-20
• Target enrollment: 0
• Participant gender: All

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 Study GA30044 (NCT02908100) up to 48 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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