Medarex/MedImmune SLE drug enters Ph IIa
US drugmaker Medarex says that its partner MedImmune has initiated a Phase IIa multi-dose clinical trial of MEDI-545 for the potential treatment of systemic lupus erythematosus.
The fully-human antibody was generated by Medarex' UltiMAb Human Antibody Development System. Under the terms of the agreement, the originator will receive an undisclosed milestone payment.
The Phase IIa clinical trial is designed to evaluate the safety and tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo in adult patients with moderate-to-severe active lupus. The study will also assess the effects of MEDI-545 on disease activity in lupus patients. This randomized, double-blind, placebo-controlled trial is expected to enroll 80 patients and will be conducted at 20 sites in the USA.
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