Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xolair · 4 trials · 1 indication
A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group.
| Arm | Type | Description |
|---|---|---|
| Xolair | EXPERIMENTAL | The subcutaneous dose of Xolair administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| placebo | PLACEBO_COMPARATOR | The subcutaneous dose of placebo administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study. Participants were permitted to use albuterol as rescue medicine throughout the study. |
| Name | Type | Description |
|---|---|---|
| omalizumab (Xolair) | DRUG | Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP. |
| placebo | DRUG | Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab. |
| corticosteroids | DRUG | Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day. |
| long-acting beta-agonists | DRUG | 50 µg salmeterol twice daily or 12 µg formoterol twice daily. |
| Xolair (omalizumab) | DRUG | - |
Inclusion Criteria: * Signed Informed Consent Form and an informed assent, if applicable * Be between the ages of 12 to 75 years * Have had a history of moderate to severe asthma for at least one year prior to screening * Have had treatment with a stable regimen of of salmeterol 50 µg twice a day (...
Omalizumab is an investigational drug being studied for peanut hypersensitivity, chronic idiopathic urticaria, nasal polyps, asthma, and allergic asthma. It is developed by Roche Holding AG (RHHBY) and is currently in Phase 3 clinical development. The drug has not been approved by the FDA and remains under investigation.
Omalizumab targets immunoglobulin E (IgE), a key driver of allergic responses. By binding to IgE, it is designed to reduce allergic inflammation. This mechanism is relevant across its studied indications, including allergic asthma and nasal polyps.
Omalizumab is developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug for multiple allergic and inflammatory conditions.
Omalizumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Four clinical trials have been completed, with no active trials currently ongoing.
Omalizumab has completed four clinical trials, including NCT00434434 in mild allergic asthma, NCT03280537 and NCT03280550 in chronic rhinosinusitis with nasal polyps, and NCT03478930, an extension study in the same condition. All trials are completed.
Omalizumab is also known as Xolair, a brand name for the drug. It is being studied for conditions such as nasal polyps and allergic asthma, and is developed by Roche Holding AG.