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.
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.
Asthma
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to…
- Trial name
- NCT00639691
- Testing
- omalizumab
- Where
- Canada
- Volunteers
- 48 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
Asthma
Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1.
- Trial name
- NCT00482508
- Testing
- Omalizumab
- Volunteers
- 95 people
- Sponsor
- Novartis
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
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
Asthma
Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations
A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled…
- Trial name
- NCT01460862
- 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.
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
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
A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma.
- Trial name
- NCT00401596
- Testing
- Xolair (omalizumab)
- Volunteers
- 1,899 people
- Sponsor
- Genentech, Inc.
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
Allergic Asthma
Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab…
- Trial name
- NCT05424523
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 200 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
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
Allergic Asthma
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level).
- Trial name
- NCT01155700
- Testing
- omalizumab
- Where
- 17 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.
- Trial name
- AA007 (NCT01976208)
- Testing
- Omalizumab
- Where
- 27 sites in China
- Volunteers
- 630 people
- Sponsor
- Shanghai Zhangjiang Biotechnology Limited Company
Asthma
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age…
- Trial name
- NCT00500539
- Testing
- omalizumab
- Where
- 31 sites in United States, Argentina and 1 more
- Volunteers
- 155 people
- Sponsor
- Novartis