NCT02908100

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	GDC-0853	Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
DRUG	Placebo	Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.

Timeline

• Start date: 2017-01-19
• Primary completion: 2019-05-28
• Completion: 2019-07-16
• First posted: 2016-09-20
• Last updated: 2024-05-08
• Results posted: 2020-07-07

Locations

70 sites across 12 countries: United States, Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Mexico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study