Clinical trials: Omalizumab
Asthma
Sputum-derived Cellular Targets After Xolair (Omalizumab)
The primary purpose of this study is to identify additional mechanisms of action of omalizumab that will lead to improved stratification of patients for treatment.
- Trial name
- NCT02658877
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- NYU Langone Health
Anaphylaxis, Hypotension
A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
Background: Omalizumab is an approved drug for the treatment of asthma by the Food and Drug Administration. Researchers are now studying this drug in a double-blind placebo-controlled manner to assess efficacy in patients with…
- Conditions
- Anaphylaxis, Hypotension, Bronchospasm, Angioedema
- Trial name
- NCT00890162
- Testing
- Epinephrine, Omalizumab (Xolair)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Idiopathic Urticaria
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
- Trial name
- NCT01599637
- Testing
- IGE025
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S.
- Trial name
- NCT02023151
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Johns Hopkins University
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
Solar Urticaria
Omalizumab in Severe and Refractory Solar Urticaria
Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on…
- Trial name
- XOLUS (NCT02262130)
- Testing
- Omalizumab
- Where
- 13 sites in France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
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
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis.
- Trial name
- X-PAND (NCT00813748)
- Testing
- Xolair
- Where
- 7 sites in United States
- Volunteers
- 118 people
- Sponsor
- Genentech, Inc.
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
Asthma
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also.
- Trial name
- NCT01716754
- Testing
- QGE031, Omalizumab
- Where
- 150 sites in United States, Argentina and 22 more
- Volunteers
- 471 people
- Sponsor
- Novartis Pharmaceuticals
Symptomatic Dermographism
Urticaria Facticia Treatment With Omalizumab (UFO)
Urticaria is a very frequent skin condition characterized by transient wheal and flare type skin reactions associated with severe pruritus.
- Trial name
- UFO (NCT02169115)
- Testing
- Omalizumab
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Charite University, Berlin, Germany
Idiopathic Angioedema
Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to 2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced angioedema, the majority of episodes were…
- Trial name
- NCT02966314
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Wisconsin, Madison
Nasal Polyps, Chronic Rhinosinusitis
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to…
- Trial name
- POLYP 1 (NCT03280550)
- Testing
- Omalizumab
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 138 people
- Sponsor
- Hoffmann-La Roche
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
Bullous Pemphigoid
Efficacy and Safety of Omalizumab in Bullous Pemphigoid
The primary objective is to test the safety and efficacy of Xolair in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP). This is a pilot, open label case-control study.
- Trial name
- NCT00472030
- Testing
- Omalizumab, prednisone
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Iowa
Chronic Spontaneous Urticaria
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine…
- Trial name
- omalizumab (NCT04426890)
- Testing
- CT-P39, EU-approved Xolair
- Where
- Poland
- Volunteers
- 634 people
- Sponsor
- Celltrion
Milk Allergy
OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life.
- Trial name
- NCT01157117
- Testing
- Omalizumab, Milk powder
- Where
- 3 sites in United States
- Volunteers
- 77 people
- Sponsor
- Hugh A Sampson, MD
Allergic Asthma
Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
A single center pilot study to determine the protective effects of RhuMAB-E25 on airway physiology and biology in allergic asthmatics that undergo bronchoprovocation with methacholine.
- Trial name
- NCT00829179
- Testing
- RhuMab-E25
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Duke University
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
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