Clinical trials: Omalizumab
Chronic Spontaneous Uriticaria
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
This was a 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 of…
- Trial name
- NCT02329223
- Testing
- Omalizumab
- Where
- 39 sites in Japan, South Korea
- Volunteers
- 218 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
mRNA Expression as a Biomarker of Omalizumab Response
Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and monitor the response to omalizumab in patients with difficult control asthma 2.
- Trial name
- NCT01584687
- Testing
- Omalizumab
- Volunteers
- 6 people
- Sponsor
- Instituto de Investigação em Imunologia
Asthma
An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g.
- Trial name
- NCT00109187
- Testing
- Xolair (omalizumab)
- Sponsor
- Genentech, Inc.
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.
Atopic Dermatitis
Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients
Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels.
- Trial name
- NCT00822783
- Testing
- Omalizumab
- Where
- Austria
- Sponsor
- Medical University of Vienna
Asthma
ICATA Asthma Mechanistic Study
The purposes of this study are to determine the effects of omalizumab on cells involved in the allergic response, to evaluate predictors of response to omalizumab, and to determine whether response to omalizumab therapy is…
- Trial name
- NCT00377390
- Testing
- Omalizumab
- Where
- 4 sites in United States
- Volunteers
- 224 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Idiopathic Urticaria
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the…
- Trial name
- NCT00866788
- Testing
- omalizumab, H1 antihistamines, Diphenhydramine
- Volunteers
- 90 people
- Sponsor
- Genentech, Inc.
Allergies, Food Allergy
Omalizumab Weight-Based Dosing Efficacy Trial
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
- Trial name
- OWED-T (NCT06943534)
- Testing
- 5mg/kg omalizumab injection, 15mg/kg omalizumab injection
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Massachusetts General Hospital
Food Allergy
Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food…
- Trial name
- MAP-X (NCT02643862)
- Testing
- Xolair
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Stanford University
Hyper-IgE Syndrome, Job's Syndrome
Omalizumab to Treat Hyper-IgE (Job's) Syndrome
This study will evaluate the safety and effectiveness of a laboratory-made antibody called omalizumab in patients with Job's syndrome, or hyper-IgE syndrome (HIES).
- Trial name
- NCT00260702
- Testing
- Omalizumab (Xolair)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Asthma
Cross-sectional Study for Identification and Description of Severe Asthma Patients
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered.
- Trial name
- NCT02293265
- Testing
- Short Acting Beta Agonist (SABA)
- Where
- 74 sites in United States, Australia and 4 more
- Volunteers
- 767 people
- Sponsor
- GlaxoSmithKline
Asthma, Eosinophilic Asthma
Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood.
- Trial name
- NCT04585997
- Testing
- Mepolizumab, Omalizumab
- Where
- Australia
- Volunteers
- 200 people
- Sponsor
- University of Newcastle, Australia
Moderate to Severe Allergic Asthma
A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE)
Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which…
- Trial name
- ESSENCE (NCT06348407)
- Testing
- IgE monoclonal antibody
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.
- Trial name
- NCT00482248
- Testing
- Omalizumab
- Volunteers
- 132 people
- Sponsor
- Novartis
Peanut Allergy, Food Allergy
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy.
- Trial name
- PRROTECT (NCT01781637)
- Testing
- Omalizumab
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Boston Children's Hospital
Peanut Allergy
Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today.
- Trial name
- FASTX (NCT02402231)
- Testing
- Omalizumab
- Where
- Sweden
- Volunteers
- 23 people
- Sponsor
- Caroline Nilsson
Food IgE-mediated Allergy, Immunotherapy
Omalizumab to Accelerate a Symptom-driven Multi-food OIT
This study will determine the dose-related efficacy of a 20-week treatment of omalizumab started 8 weeks before the onset of a symptom-driven multi-food oral immunotherapy (OIT) protocol at decreasing time to OIT maintenance…
- Conditions
- Food IgE-mediated Allergy, Immunotherapy, Omalizumab, Physiological Effects of Drugs
- Trial name
- BOOM (NCT04045301)
- Testing
- Omalizumab 16mg/kg, Omalizumab 8mg/kg, Multi-food oral immunotherapy (OIT)
- Where
- 3 sites in Canada
- Volunteers
- 90 people
- Sponsor
- Philippe Bégin
Esophagitis
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults.
- Trial name
- NCT00123630
- Testing
- omalizumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Utah