Clinical trials: Omalizumab
Chronic Idiopathic Urticaria
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01292473
- Testing
- Omalizumab
- Where
- 61 sites in United States, Denmark and 6 more
- Volunteers
- 323 people
- Sponsor
- Genentech, Inc.
Persistent Allergic Asthma
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
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…
- Trial name
- NCT01202903
- Testing
- Omalizumab
- Where
- 39 sites in China
- Volunteers
- 616 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Urticaria
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
- Trial name
- NCT00481676
- Testing
- Omalizumab 75-375 mg, Loratadine, Clemastine
- Where
- 11 sites in Germany
- Volunteers
- 49 people
- Sponsor
- Novartis
Asthma
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks.
- Trial name
- NCT00079937
- Testing
- Omalizumab, Fluticasone
- Where
- 56 sites in United States
- Volunteers
- 628 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Rhinosinusitis With Nasal Polyps, Asthma
EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives To evaluate the efficacy of dupilumab in improving chronic…
- Trial name
- EVEREST (NCT04998604)
- Testing
- Dupilumab, Omalizumab
- Where
- 87 sites in United States, Belgium and 15 more
- Volunteers
- 360 people
- Sponsor
- Sanofi
CHRONIC SPONTANEOUS URTICARIA
Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.
- Trial name
- SUNRISE (NCT02550106)
- Testing
- OMALIZUMAB
- Where
- 29 sites in France
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy…
- Trial name
- NCT04018313
- Testing
- CT-P39, EU-approved Xolair, US-licensed Xolair
- Where
- 2 sites in Australia
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Celltrion
Asthma
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control.
- Trial name
- NCT00264849
- Testing
- Omalizumab, Optimized asthma therapy
- Where
- 17 sites in Belgium, Canada and 15 more
- Volunteers
- 406 people
- Sponsor
- Novartis
Chronic Spontaneous Urticaria
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who…
- Trial name
- NCT03328897
- Testing
- Omalizumab
- Where
- 27 sites in China
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Nasal Polyps, Chronic Rhinosinusitis
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to…
- Trial name
- POLYP 2 (NCT03280537)
- Testing
- Omalizumab
- Where
- 45 sites in United States, Belgium and 8 more
- Volunteers
- 127 people
- Sponsor
- Hoffmann-La Roche
Seasonal Allergic Rhinitis
Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
The purpose of this study was to demonstrate the efficacy and safety of omalizumab compared with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent patients with severe Japanese cedar…
- Trial name
- NCT03369704
- Testing
- Omalizumab
- Where
- 22 sites in Japan
- Volunteers
- 337 people
- Sponsor
- Novartis Pharmaceuticals
Peanut Hypersensitivity
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the…
- Trial name
- NCT00382148
- Testing
- omalizumab
- Volunteers
- 11 people
- Sponsor
- Genentech, Inc.
Asthma
Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with…
- Trial name
- NCT00454051
- Testing
- Omalizumab
- Where
- France
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.
- Trial name
- NCT00396409
- Testing
- Depigoid, Omalizumab
- Where
- Germany
- Volunteers
- 128 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction…
- Trial name
- AERO (NCT00495612)
- Testing
- Omalizumab
- Volunteers
- 69 people
- Sponsor
- Genentech, Inc.
Chronic Urticaria
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria…
- Trial name
- NCT04976192
- Testing
- TEV-45779, XOLAIR® Injection
- Where
- 9 sites in United States
- Volunteers
- 608 people
- Sponsor
- Teva Pharmaceuticals USA
Asthma
Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
This study investigated asthma-related quality of life in Brazilian patients using omalizumab.
- Trial name
- NCT00567476
- Testing
- Omalizumab, Inhaled corticosteroids (ICS), Long-acting beta 2-adrenergic agonist (LABA)
- Where
- Brazil
- Volunteers
- 116 people
- Sponsor
- Novartis
Asthma
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
- Trial name
- NCT00624832
- Testing
- Xolair
- Where
- 6 sites in Germany, Netherlands and 1 more
- Volunteers
- 60 people
- Sponsor
- Novartis
Asthma
A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old…
- Trial name
- NCT00314574
- Testing
- omalizumab (Xolair), corticosteroids, long-acting beta-agonists
- Volunteers
- 850 people
- Sponsor
- Genentech, Inc.
Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.
- Trial name
- NCT00787917
- Testing
- Omalizumab, Itraconazole
- Where
- 10 sites in Belgium, Germany and 3 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals