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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
150 mg tablet, oral, twice-a-day
Placebo tablet, oral, twice-a-day
The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months.
Time frame: 6 months
Composite Responder analysis defined as ≥4 points improvement in SELENA-SLEDAI and no 'Severe SLE flare' after Week 6. No worsening (≤10 mm on VAS) of Physician Global Assessment, or, no worsening of SF 36 PCS (not >-0.8) or PFI (not >2.5)
Time frame: 3 and 6 months
Attainment of daily prednisone dose decrease in those patients on daily corticosteroids by 50% or to ≤ 7.5 mg prednisone (or equivalent for other corticosteroids) at 3 and 6 months.
Time frame: 3 and 6 months
Decrease from baseline in SELENA-SLEDAI score at each post baseline visit.
Time frame: At each post baseline visit
Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4.
Time frame: Weeks 2 and 4
Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit.
Time frame: At each post baseline visit
Change from baseline of Physician Global Assessment by VAS over 6 months.
Time frame: 6 months
Time to rescue medication.
Time frame: At each post baseline visit
Time to severe SLE flare by SELENA Flare Index.
Time frame: At each post baseline visit
Change from baseline in the component scores of the SF 36 at Month 3 and Month 6.
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Time frame: Month 3 and 6
Effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I adverse effects, new onset or aggravated hypertension, and other adverse effects as they may appear.
Time frame: At each post baseline visit