A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels

Novartis

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Xolair

Study type: Interventional

Funder types: Industry

Identifiers

NCT00624832

CIGE025A2210

Details and patient eligibility

About

This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adult patients, body weight between 40-150 kg aged 18-65 years (inclusive)
• Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) ≥65% of the predicted normal value for the patient
• Positive skin prick test to a specific allergen
• Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening

Exclusion criteria

• Current active smokers
• Patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start
• History of bleeding disorders
• History of drug allergy
• Pregnant women or nursing mothers
• Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
• Sexually active males who have not been sterilized and are not using a condom
• History of immunocompromise, including a positive HIV
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• History of drug or alcohol abuse within 12 months of study start

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)

Experimental group

Description:

Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.

Treatment:

Drug: Xolair

Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL)

Experimental group

Description:

Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.

Treatment:

Drug: Xolair

Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL)

Experimental group

Description:

Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.

Treatment:

Drug: Xolair

Placebo

Placebo Comparator group

Description:

By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.

Treatment:

Drug: Placebo