Clinical trials: Omalizumab
Allergic Asthma
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and…
- Trial name
- NCT06494345
- Testing
- Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Xolair®, solution for subcutaneous administration, 150 mg
- Where
- Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
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 Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a…
- Trial name
- EXACT (NCT00096954)
- Testing
- omalizumab (Xolair)
- Volunteers
- 333 people
- Sponsor
- Genentech, Inc.
Similarity of Pharmacokinetics and Safety
Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.
- Trial name
- NCT04361812
- Testing
- HS632, Omalizumab (Xolair®)
- Where
- China
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Nasal Polyps, Chronic Rhinosinusitis
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the…
- Trial name
- NCT03478930
- Testing
- Omalizumab
- Where
- 79 sites in United States, Belgium and 12 more
- Volunteers
- 249 people
- Sponsor
- Hoffmann-La Roche
Steroid and/or Prednisone Dependent Asthma, Eosinophilic Bronchitis
Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.
- Trial name
- NCT02049294
- Testing
- Omalizumab (Xolair)
- Where
- 5 sites in Canada
- Volunteers
- 11 people
- Sponsor
- McMaster University
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
Allergy Induced Asthma
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful.
- Trial name
- NCT00242359
- Testing
- omalizumab
- Sponsor
- Bernstein Clinical Research Center
Asthma
Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus
Population surveys have shown a positive correlation between increased levels of total serum immunoglobulin E (IgE) and bronchial hyperreactivity.
- Trial name
- NCT02388997
- Testing
- omalizumab, Rhinovirus (strain 16)
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Virginia
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
Chronic Urticaria, Chronic Idiopathic Urticaria
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
The aim of this study is to investigate the pathophysiological mechanism of omalizumab in patients with documented chronic urticaria who have complaints under standard antihistamine treatment.
- Conditions
- Chronic Urticaria, Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria
- Trial name
- NCT01803763
- Testing
- Omalizumab (Xolair)
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Chronic Urticaria
Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria
Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema.
- Trial name
- NCT01713725
- Testing
- Omalizumab
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Chronic Urticaria
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.
- Trial name
- NCT01701583
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Colorado, Denver
Eosinophilic Esophagitis
Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea, epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal symptoms along with obstructive esophageal symptoms in…
- Trial name
- NCT01040598
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- O & O Alpan LLC
Asthma
A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe…
- Trial name
- NCT01922037
- Testing
- Omalizumab
- Where
- 145 sites in United States
- Volunteers
- 806 people
- Sponsor
- Hoffmann-La Roche
Peanut Allergy
Xolair Enhances Oral Desensitization in Peanut Allergic Patients
This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.
- Trial name
- NCT01290913
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Lynda Schneider
Asthma
Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved…
- Trial name
- NCT00691873
- Testing
- Xolair
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Mississippi Medical Center
Atopic Dermatitis
Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis
A phase 1 single center study in which omalizumab is dosed normally (according to the product insert) in subjects with atopic dermatitis.
- Trial name
- OXAD (NCT01678092)
- Testing
- omalizumab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Stanford University
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.
Aspirin Sensitivity
Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair injections will occur every 2-4 weeks.
- Trial name
- NCT00555971
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- David Lang