Trials / Terminated
TerminatedNCT03407482
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 76 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GDC-0853 | Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above. |
Timeline
- Start date
- 2018-01-09
- Primary completion
- 2019-11-20
- Completion
- 2019-11-20
- First posted
- 2018-01-23
- Last updated
- 2020-12-19
- Results posted
- 2020-12-19
Locations
53 sites across 11 countries: United States, Argentina, Brazil, Bulgaria, Chile, Colombia, Mexico, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03407482. Inclusion in this directory is not an endorsement.