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Also known as Omalizumab
Omalizumab 75 · 1 trial · 1 indication
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Omalizumab 75-375 mg | EXPERIMENTAL | Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. |
| Placebo to omalizumab | PLACEBO_COMPARATOR | Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. |
| Name | Type | Description |
|---|---|---|
| Omalizumab 75-375 mg | DRUG | Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection. |
| Placebo to omalizumab | DRUG | Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection. |
| Loratadine | DRUG | All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines. |
| Clemastine | DRUG | All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines. |
Inclusion criteria: * Males or females from 18-70 years of age * Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL * Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening * Diagnosis of mo...
Omalizumab is used for persistent allergic asthma, seasonal allergic rhinitis, chronic urticaria, and chronic spontaneous urticaria. It is an investigational therapy in Phase 3 clinical development for these respiratory and allergy-related conditions.
Omalizumab is a monoclonal antibody that targets immunoglobulin E (IgE), a key driver of allergic responses. By binding to IgE, it is designed to reduce allergic inflammation associated with conditions like asthma and chronic urticaria.
Omalizumab is developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Omalizumab is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Multiple Phase 3 trials have been completed to assess its effects in patients with asthma.
Omalizumab has been studied in several completed clinical trials, including NCT00046748, which evaluated its efficacy and safety in 484 patients with severe persistent asthma, and NCT00482508, a safety study in 95 patients with poorly controlled asthma. Other trials include NCT01007149 and NCT03727971.
Omalizumab is also known by the brand name Xolair. It is a monoclonal antibody developed for allergic conditions such as asthma and chronic urticaria. The drug is being developed by Novartis AG.