Clinical trials: Omalizumab
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.
Allergic Asthma
Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children
The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite…
- Trial name
- NCT01328886
- Testing
- Omalizumab
- Where
- 15 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics…
- Trial name
- eXplore (NCT00670930)
- Testing
- omalizumab at a dose of 0.016mg/kg/IU/mL
- Where
- 16 sites in United States, Canada and 5 more
- Volunteers
- 36 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 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
Asthma
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.
- Trial name
- NCT00046748
- Testing
- Omalizumab
- Volunteers
- 484 people
- Sponsor
- Novartis Pharmaceuticals
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.
Chronic Urticaria
A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China
The aim of this study was to characterize the real-world treatment patterns of omalizumab among adult patients with chronic urticaria in China using data from a regional electronic healthcare (rEHR) database.
- Trial name
- NCT07450170
- Where
- China
- Volunteers
- 3,485 people
- Sponsor
- Novartis Pharmaceuticals
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
Allergy
A Safety and Efficacy Study of Xolair in Peanut Allergy
This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.
- Trial name
- NCT00086606
- Testing
- Xolair (omalizumab)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Genentech, Inc.
Asthma
Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma
- Trial name
- NCT00546143
- Testing
- Omalizumab
- Where
- 5 sites in Germany, South Africa
- Volunteers
- 32 people
- Sponsor
- Novartis
Asthma
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an…
- Trial name
- NCT00252135
- Volunteers
- 8,023 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
Asthma
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe…
- Trial name
- NATAIR (NCT01007149)
- Testing
- omalizumab
- Where
- 10 sites in France
- Volunteers
- 79 people
- Sponsor
- Novartis Pharmaceuticals
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
Asthma
A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma
This is a continued access protocol to provide subjects who have completed Genentech, Inc. Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1 with continued Xolair treatment.
- Trial name
- NCT00109200
- Testing
- Xolair (omalizumab)
- Sponsor
- Genentech, Inc.
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
Chronic Spontaneous Urticaria
OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first…
- Trial name
- OPTIMA (NCT02161562)
- Testing
- omalizumab
- Where
- 35 sites in Argentina, Brazil and 6 more
- Volunteers
- 314 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
- Trial name
- NCT02477332
- Testing
- QGE031, Omalizumab
- Where
- 82 sites in United States, Australia and 8 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Asthma, Allergies
Impact of Asthma Treatments on Daily Activities
The primary objective of this web-based, cross-sectional study is to assess and compare the ability to sleep, work or go to school, and to participate in leisure activities among subjects who are receiving Xolair treatment and…
- Trial name
- NCT00350376
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Ovation Research Group