Date: 2016-03-02
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Merck KGaA (Germany)
Product: MSB11022, a biosimilar version of Humira® (adalimumab)
Action
mechanism: biosimilar/monoclonal antibody. Adalimumab is a recombinant human monoclonal antibody that binds specifically to tumour necrosis factor-alpha (TNF-alpha), blocking interaction with its cell surface receptors and thereby reducing the impact of inflammation.
Disease: moderate to severe chronic plaque psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: Bulgaria, Canada, Czech Republic, Germany,Hungary, Poland, USA
Trial
details: The AURIEL-Psoriasis (PsO) study is a randomized, double-blind, active-controlled trial evaluating the efficacy, safety and immunogenicity of Merck KGaA’s adalimumab biosimilar candidate MSB11022 compared with the brand Humira® (adalimumab) in patients with moderate to severe chronic plaque psoriasis.(NCT02660580 )
Latest
news: * On March 2, 2016, Merck KGaA announced the initiation of a global phase III clinical study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis. “With the first patient now treated in our adalimumab biosimilar candidate study, we are moving closer to expanding access to affordable, high quality biologics for people living with serious diseases,” said Michael Soldan, Head of the Biosimilar Business of Merck. “
The study is expected to recruit approximately 400 patients across Europe, Asia and North and Central America.
