Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

Novartis

Status and phase: Completed; Phase 3

Conditions: Persistent Allergic Asthma

Treatments: Drug: Placebo; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202903

CIGE025A2313

Details and patient eligibility

About

This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.

Enrollment: 616 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30 to ≤ 700 IU/mL and body weight > 20 kg and ≤ 150 kg)
• Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is not adequately controlled with GINA (2009) Step 4 therapy
• Received medium-to-high dose inhaled corticosteroid > 500 µg Beclomethasone Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or in combination, for at least 8 weeks prior to screening
• Met specific asthma exacerbations eligibility criteria prior to the screening period
• Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping with GINA 2009 guidelines)
• Positive skin prick test to at least one perennial aeroallergen documented by a historical test within 12 months prior to screening, or at Visit 1
• FEV1 ≥ 40% and < 80% of the predicted normal value for the patient (using local standards), after withholding bronchodilators at Visit 2

Exclusion criteria

• Used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. For biological agent-based investigational drugs, such as monoclonal antibodies, at least six months will need to have passed between the last administration of the drug and the patient's Screening Visit.
• History of malignancy
• History of allergies and diseases that could interfere with the analyses
• Clinically significant abnormality on a 12-lead ECG recorded at Visit 1
• Elevated IgE levels for reasons other than allergy
• Current smokers, or a former smoker with a smoking history of > 10 pack-years. A former smoker must have abstained for a minimum of 12 months before randomization
• Receiving specific medications
• Clinically significant laboratory abnormalities (not associated with the study indication) at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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616 participants in 2 patient groups, including a placebo group

Omalizumab

Experimental group

Description:

Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.

Treatment:

Drug: Omalizumab

Placebo

Placebo Comparator group

Description:

The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.

Treatment:

Drug: Placebo