"We appreciate the
The Phase 3 studies (CHABLIS-SC1 and CHABLIS-SC2) will be multicenter, placebo-controlled, randomized, double-blind studies designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with clinically active SLE (SELENA-SLEDAI > 10) who have not achieved optimal resolution of their disease with corticosteroid use. Patients will be treated in the controlled part of each study for 52 weeks after which they will have the option to receive additional treatment as part of an open-label, long-term, follow-up safety study. The primary endpoint of the CHABLIS studies will be a Systemic Lupus Erythematosus Response Index (SRI*) including the requirement of an eight-point or greater improvement from baseline in the
"The use of an SRI-8 endpoint, in a population with higher baseline disease activity requires patients to demonstrate improvement in the clinical presentations of SLE, such as skin, mucosal, joint disease and kidney disease," said
As previously reported, results from the PEARL-SC study indicate that in the predefined population of patients with clinically active disease (SELENA-SLEDAI > 10) who were also taking corticosteroids, the SRI-8 treatment benefit in the 200 mg weekly blisibimod cohort was statistically significant at week eight (22.6% blisibimod response versus 6.4% placebo response, p=0.023) and at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p < 0.001). Results from the PEARL-SC clinical study have been submitted to the
*SRI is defined as patients who respond to treatment and achieve a reduction in SELENA-SLEDAI equal to or greater than the number indicated, no new BILAG A or two B organ domain scores, and no increase in Physician's Global Assessment (PGA) of greater than 0.3 on a three point scale.
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