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Placebo for Omalizumab
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in clinical trials for omalizumab (anti-IgE monoclonal antibody for moderate-to-severe allergic asthma and chronic idiopathic urticaria).
At a glance
| Generic name | Placebo for Omalizumab |
|---|---|
| Also known as | Placebo, Placebo for Xolair |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Placebo is an inert substance used as a control in clinical trials to establish baseline efficacy and safety of an active drug (in this case, omalizumab). Any observed effects are attributable to the placebo effect—psychological and physiological responses to the expectation of treatment rather than the substance itself.
Approved indications
- Control arm in clinical trials for omalizumab (anti-IgE monoclonal antibody for moderate-to-severe allergic asthma and chronic idiopathic urticaria)
Common side effects
Key clinical trials
- Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. (PHASE3)
- A Study to Find a Suitable Dose of Exl-111 for Further Research (PHASE1)
- Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (PHASE2)
- Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients (PHASE3)
- EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (PHASE4)
- Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (PHASE3)
- Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (PHASE3)
- Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID) (PHASE3)
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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