Phase III trial of AMG 412 (epratuzumab) fails in Systemic Lupus Erythematosus- UCB

UCB announced that the two EMBODY Phase III clinical studies for AMG 412 (epratuzumab) in Systemic Lupus Erythematosus (SLE) did not meet their primary clinical efficacy endpoints in either dose in both studies. Treatment response in patients who received epratuzumab in addition to standard therapy was not statistically significantly higher than those who received placebo in addition to standard therapy.

The EMBODY Phase III clinical program consisted of two identical studies � EMBODY 1 and EMBODY 2. EMBODY 1 and EMBODY 2 were multicenter, randomized, double-blind, placebo-controlled 48-week studies. In each study, patients (n= 786 for EMBODY 1; n=788 for EMBODY 2) received placebo or treatment with 2400 mg of epratuzumab over four 12-week treatment cycles, administered as 600 mg every week for four weeks or 1,200 mg every two weeks for four weeks. All patients were taking corticosteroids at the start of the trial, in addition to epratuzumab or placebo, while immunosuppressant and antimalarial therapies were administered per their standard therapy regimen.

The primary endpoint of the studies was the percentage of patients meeting treatment response criteria at Week 48 according to a combined response index, the BILAG-based Combined Lupus Assessment (BICLA). A high level review of the safety data did not identify any new safety concerns. The most common adverse events in both studies were upper respiratory tract infection, urinary tract infection, headache and nausea.