NCT00752999

Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.

Detailed description

This study is a multi-center, multinational, randomized, double-blind, placebo-controlled Phase II clinical trial. Study enrollment will comprise approximately 225 patients meeting study inclusion requirements. The study will be conducted at up to 80 multinational investigational sites. Eligible patients will be randomized (2:1) into one of two 6 month treatment groups. One group (approximately 150 patients) will receive R788 150 mg PO bid; the other treatment group (approximately 75 patients) will receive placebo.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Fostamatinib Disodium (R935788)	150 mg tablet, oral, twice-a-day
DRUG	Placebo	Placebo tablet, oral, twice-a-day

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-11-01
• Completion: 2010-03-01
• First posted: 2008-09-16
• Last updated: 2012-04-30