NCT03468790

Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.

A Multi-centre, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Anti-IgE Monoclonal Antibody to Treat Allergic Asthma Patients Not Adequately Controlled Despite Med/High ICS/LABA.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 400 asthma patients with an increased serum total IgE level(60-1500 international unit(IU)/ml) and uncontrolled receiving medium to high dose inhaled corticosteroid (ICS) plus long-acting β2-agonist(LABA) will be randomised in about 43 sites in China. They will be administered CMAB007 or placebo at a ratio of 2:1 for 24 weeks. During the whole study, all subjects will be on regularly fixed combination of med/high ICS and LABA (budesonide and formoterol fumarate powder for inhalation or salmeterol xinafoate and fluticasone propionate powder for inhalation). They should complete PEF measurement and patient diary daily and be assessed every 4 weeks. Spirometry, questionnaires, laboratory tests and so on will be performed. At selected sites, about 45 patients will be enrolled in a sub-study to assess the pharmacokinetic and pharmacodynamic characterises of CMAB007. Anti-drug antibody (ADA) will be sampled at V1, V2 and V7 too.

Conditions

• Asthma, Allergic

Interventions

Type	Name	Description
DRUG	CMAB007	the study drug
DRUG	Symbicort	asthma-controlled drug
DRUG	Seretide	asthma-controlled drug
DRUG	Ventolin	asthma rescue drug
DRUG	placebo	No active components

Timeline

• Start date: 2018-05-09
• Primary completion: 2021-01-12
• Completion: 2021-03-09
• First posted: 2018-03-19
• Last updated: 2021-10-11

Locations

2 sites across 1 country: China