UCB announces start of phase III programme with epratuzumab for patients with moderate to severe systemic lupus erythematosus

Phase III programme follows positive phase IIb study EMBLEM, which showed that epratuzumab reduced disease activity over a 12 week treatment period

15-Dec-2010 - Belgium

UCB and U.S. based partner Immunomedics Inc. announced the enrollment of the first patient into EMBODY™ 1, one of two pivotal phase III studies of epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE). Patient enrollment for EMBODY™ 2 has also begun.

Both studies (EMBODY™ 1 and EMBODY™ 2) are multicenter, placebo-controlled, randomized, double-blind studies designed to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab in patients with moderate to severe SLE. Each study will last a maximum of 54 weeks and will randomize 780 patients in the study, with approximately 130 planned investigational sites per study. The phase III programme has undergone the relevant regulatory advice procedures.

The primary objective of the studies is to confirm the clinical efficacy of epratuzumab in the treatment of patients with moderate to severe general SLE, in addition to continuing standard of care treatments.

The results from the phase IIb study, EMBLEM™, showed that all epratuzumab doses, which ranged from 200mg to 3,600mg cumulative dose administered during one 12-week treatment cycle had numerically superior response rates compared to placebo at week 12. For patients receiving epratuzumab at a cumulative dose of 2,400mg there were meaningful and statistically significant reductions in SLE disease activity, with responder rates more than double those of placebo.

https://www.bionity.com/en/news/127274/ucb-announces-start-of-phase-iii-programme-with-epratuzumab-for-patients-with-moderate-to-severe-systemic-lupus-erythematosus.html