Immunomedics and UCB said that each study will will randomise 780 subjects in the study, with approximately 130 planned investigational sites per study.
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 reductions in SLE disease activity, with responder rates more than double those of placebo.
The Emblem results showed that in a patient population with predominantly high disease activity, Epratuzumab improved patients’ health at week 12, with the emergence of improvements as early as week 8.
UCB chief medical officer Iris Loew-Friedrich said that they are pleased to announce the launch of the Phase III program with Epratuzumab, which marks UCB’s intent to develop this compound for such a severe disease.
"The consistency of improvements demonstrated by Epratuzumab in the clinical studies to-date is an encouraging platform to start the next phase of trials, and is a hopeful sign of the drug’s potential to become an effective new treatment option for lupus," Loew-Friedrich said.