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

Genentech

Status and phase: Terminated; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: GDC-0853

Study type: Interventional

Funder types: Industry

Identifiers

NCT03407482

2017-001764-37 (EudraCT Number)

GA30066

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

GDC-0853 (200mg) BID

Experimental group

Description:

Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).

Treatment:

Drug: GDC-0853