Clinical trials: Omalizumab
Chronic Spontaneous Urticaria
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who…
- Trial name
- NCT03328897
- Testing
- Omalizumab
- Where
- 27 sites in China
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
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
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.
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
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
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
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
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
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
Cold Contact Urticaria
Cold Urticaria Treatment With Xolair
Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus.
- Trial name
- CUTEX (NCT01580592)
- Testing
- Omalizumab
- Where
- 3 sites in Germany
- Volunteers
- 31 people
- Sponsor
- Charite University, Berlin, Germany
Persistent Allergic Asthma
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood…
- Trial name
- NCT00870584
- Testing
- Omalizumab
- Where
- 50 sites in United States
- Volunteers
- 271 people
- Sponsor
- Novartis Pharmaceuticals
ALLERGIC ASTHMA
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe…
- Trial name
- NCT00283504
- Testing
- ANTI-IGE THERAPY (XOLAIR)
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of The King's Daughters
Chronic Urticaria
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria…
- Trial name
- NCT04976192
- Testing
- TEV-45779, XOLAIR® Injection
- Where
- 9 sites in United States
- Volunteers
- 608 people
- Sponsor
- Teva Pharmaceuticals USA
Allergic Rhinitis
The Effect of Omalizumab on Responses to Cat Allergen Challenge
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies.
- Trial name
- NCT00604786
- Testing
- omalizumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
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
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