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

Sponsor
Rigel Pharmaceuticals
Study ID
NCT00752999
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2008
Status verified
Apr 2012
Primary completion
Nov 30, 2009
Completion
Mar 31, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    150 mg tablet, oral, twice-a-day
  • Placebo Comparator: B
    Placebo tablet, oral, twice-a-day

Primary Outcome Measure

The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months. [ Time Frame: 6 months ]

Related Studies