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

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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)

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

Trial documents
1

Trial contacts and locations

53

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Data sourced from clinicaltrials.gov

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