Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Asthma, Allergic
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: placebo parallel-controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 75 years
- Gender
- Both males and females
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 ?2-agonist(LABA) will be randomised in about 43 sites in China. They will be administered CMAB007 ...
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 ?2-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.
Tracking Information
- NCT #
- NCT03468790
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nanshan Zhong, M.D. The First Affiliated Hospital of Guangzhou Medical University
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