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Randomisation to omalizumab
Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing its interaction with high-affinity IgE receptors on mast cells and basophils.
Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing its interaction with high-affinity IgE receptors on mast cells and basophils. Used for Moderate-to-severe allergic asthma, Chronic spontaneous urticaria, Nasal polyposis with eosinophilic granulomatosis with polyangiitis (EGPA).
At a glance
| Generic name | Randomisation to omalizumab |
|---|---|
| Also known as | Active-controlled |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Drug class | IgE antagonist monoclonal antibody |
| Target | Immunoglobulin E (IgE) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | FDA-approved |
Mechanism of action
By sequestering free IgE, omalizumab reduces the activation of mast cells and basophils, which are key effector cells in allergic and IgE-mediated inflammatory responses. This mechanism reduces the release of inflammatory mediators such as histamine and leukotrienes, thereby suppressing allergic cascade reactions. The drug is effective in conditions driven by IgE-mediated pathways, particularly moderate-to-severe allergic asthma and chronic spontaneous urticaria.
Approved indications
- Moderate-to-severe allergic asthma
- Chronic spontaneous urticaria
- Nasal polyposis with eosinophilic granulomatosis with polyangiitis (EGPA)
Common side effects
- Injection site reaction
- Viral upper respiratory tract infection
- Sinusitis
- Headache
- Arthralgia
Key clinical trials
- Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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