Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma (AA007)

A Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Anti-IgE Monoclonal Antibody Injection(Omalizumab) in Patients With Allergic Asthma

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: placebo; Drug: Omalizumab

Detailed Description

Omalizumab will be given as add-on treatment to budesonide inhaled powder in patients with moderate or severe allergic asthma(IgE>=60IU/ml), who demonstrate inadequate asthma symptom control. Response to Omalizumab will be assessed by the overall improvement in control of asthma.

Omalizumab is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E(IgE). The antibody has a molecular weight of approximately 150 kilodaltons and produced by Chinese Hamster Ovary cell.

Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. Reduction in surface-bound IgE on cells limits the degree of release of mediators of the allergic response.

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital
  • Beijing, China
    • Beijing ChaoYang Hospital
  • Beijing, China
    • Peking University People's Hospital
  • Changchun, China
    • The Second Hospital of Jilin University
  • Chengdu, China
    • West China Hospital, Sichuan University
  • Chongqing, China
    • Chongqing Xinqiao Hospital
  • Fuzhou, China
    • Chinese PLA Fuzhou General Hospital of Nanjing Military Command
  • Guangzhou, China
    • South Hospital of South Medical University
  • Hangzhou, China
    • Sir Run Run Shaw Hospital of Zhejiang University
  • Hangzhou, China
    • The First Affiliated Hospital of Zhejiang University
  • Hangzhou, China
    • The Second Affiliated Hospital of Zhejiang University
  • Jinan, China
    • Chinese PLA Jinan Military General Hospital
  • Jinan, China
    • Shandong Provincial Hospital
  • Nanjing, China
    • Jiangsu Province Hospital
  • Nanjing, China
    • Zhongda Hospital, Southeast University
  • Nanning, China
    • The First Affiliated Hospital of Guangxi Medical University
  • Qingdao, China
    • Qingdao Municipal Hospital
  • Shanghai, China
    • Zhongshan Hospital, Fudan University
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Shanghai, China
    • Shanghai First People's Hospital
  • Shenyang, China
    • The First Hospital of China Medical University
  • Shenyang, China
    • Chinese PLA Shenyang Military Command General Hospital
  • Shijiazhuang, China
    • The Second Hospital of Hebei Medical University
  • Tianjin, China
    • The Second Hospital of Tianjin Medica University
  • Wuhan, China
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xi'an, China
    • Xi'an Xijing Hospital
  • Beijing
    • Beijing, Beijing, China
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 15~65 years
• Written informed consent provided
• Total serum IgE >=60IU/ml
• Duration of allergic asthma >= 1 year according to GINA(2008)
• Poor response to moderate to high dose inhaled corticosteroid (400ug/day~800ug/day) >= 4 weeks
• Agreed to be not pregnant, contraception during study and later 6 months.

Exclusion Criteria:

Patients who met the below criteria were excluded:

• Be regular smokers(>10 cigarettes per day and for at least 2 years)
• Patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
• COPD, according to the guideline of Chinese society of respiratory diseases
• An active lung disease other than allergic asthma
• Patients with significant underlying medical conditions
• Allergic to immunoglobin or any formulation ingredient of the product
• Patients with diabetes or uncontrolled hypertension(Systolic blood pressure>160mmHg or Diastolic blood pressure>95mmHg)
• HIV positivity or cancer patient
• Prior exposure to Xolair

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omalizumab; During the 4~6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the following treatment phase, patients continued to receive optimized BUD and Omalizumab for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks. The dosage of Omalizumab received was based on body weight and serum IgE.	Drug: Omalizumab; The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150~300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg~750mg，then dosing interval is every 2 weeks.; Other Names: other name: Aomaishu; Recombinant Humanized Anti-IgE Monoclonal Antibody
Placebo Comparator: placebo; During the 4~6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the treatment phase, patients continued to receive placebo and optimized BUD for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with asthma exacerbation	32 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulmonary function measured by FEV1 and FEV1/FVC	32 weeks
Asthma symptoms evaluated by patients by using the Questionaire, Asthma Quality of Life Questionaire	32 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhangjiang Biotechnology Limited Company
• Investigators: Study Chair: Nanshan Zhong, M.D., The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 20, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Asthma; IgE; Omalizumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CMAB007