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

NCT03468790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2021-10-11

No results posted yet for this study

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.

Conditions

  • Asthma, Allergic

Interventions

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

Sponsors & Collaborators

  • Shanghai Biomabs Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nanshan Zhong, M.D. · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2021-01-12
Completion
2021-03-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468790 on ClinicalTrials.gov