At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 260 enrolled
Drug / intervention
GDC-0853 +1 moredrug
Likely dose
GDC-0853 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating GDC-0853 and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 260 participants across 70 sites in 12 countries.
Detailed Summary
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesArgentina, Brazil, Bulgaria, Chile, Colombia, Germany, Mexico, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartJan 2017
Primary CompletionMay 2019
Study CompletionJul 2019
TodayJul 2026
First PostedSep 20, 2016
Enrollment StartJan 19, 2017
Primary CompletionMay 28, 2019
Study CompletionJul 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.8 years ago
Interventions
GDC-0853drug
Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
Placebodrug
Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.