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

Shanghai Zhangjiang Biotechnology Limited Company

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Asthma

Treatments: Drug: placebo; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01976208

CMAB007

Details and patient eligibility

About

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

Full 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.

Enrollment: 630 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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630 participants in 2 patient groups, including a placebo group

Omalizumab

Experimental group

Description:

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.

Treatment:

Drug: Omalizumab

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo