Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.
Status:
Completed
Trial end date:
2021-03-09
Target enrollment:
Participant gender:
Summary
This is a multi-centre, randomized, double-blind，placebo parallel-controlled phase III study
to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin
E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately
controlled despite Med/high ICS plus LABA in China. Following a screening period of up to 2
weeks and run-in period of 4 weeks, randomized patients will enter a 24-week treatment period
with CMAB007 or placebo. Efficacy and safety will be assessed at 4-week intervals during the
treatment period.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai Biomabs Pharmaceutical Co., Ltd.
Treatments:
Albuterol Antibodies Antibodies, Anti-Idiotypic Antibodies, Monoclonal Budesonide Budesonide, Formoterol Fumarate Drug Combination Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Fluticasone-Salmeterol Drug Combination Formoterol Fumarate Immunoglobulins Salmeterol Xinafoate Xhance