Date: 2014-04-24
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Alexion Pharmaceuticals (USA - CT)
Product: Soliris® (eculizumab)
Action
mechanism:
- monoclonal antibody. Eculizumab is a recombinant humanized monoclonal IgG2/4 antibody that specifically binds to the complement protein C5, inhibiting its cleavage by the C5 convertase which prevents the generation of the terminal complement complex C5b-9.
- In June 2013 the FDA granted eculizumab an orphan drug designation for the treatment of neuromyelitis optica. Eculizumab was also granted orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) in August 2013.
Disease: relapsing neuromyelitis optica (NMO)
Therapeutic
area: Rare diseases - Neurological diseases
Country:
Trial
details:
- The PREVENT study is a multinational, double-blind, placebo-controlled study with the primary objective of assessing the efficacy of eculizumab compared to placebo in patients with relapsing NMO, based on the time to first relapse and relapse risk reduction. Secondary endpoints include safety and tolerability as well as additional efficacy outcome measures. Patient enrollment and dosing have commenced in this trial. Recruitment is open to adults with a diagnosis of NMO or NMO spectrum disorder with relapsing disease. (NCT01892345).
Latest
news:
- • On April 24, 2014, Alexion Pharmaceuticals has announced the initiation of a single, multinational, placebo-controlled trial to evaluate the safety and efficacy of eculizumab (Soliris®) in patients with relapsing neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.
Is
general: Yes
