Clinical trials: Omalizumab
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
Healthy Volunteers (HV)
Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, safety and immunogenicity of two formulations of Omalizumab (Process-Changed CMAB007 and Xolair) in healthy subjects.
- Trial name
- NCT07246252
- Testing
- Process-Changed CMAB007, Xolair (omalizumab)
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Asthma
Study of Omalizumab in Moderate to Severe Bronchial Asthma
This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.
- Trial name
- NCT00232050
- Testing
- Omalizumab
- Volunteers
- 327 people
- Sponsor
- Novartis
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
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
Chronic Spontaneous Urticaria
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every…
- Trial name
- NCT06042478
- Testing
- Remibrutinib, Omalizumab
- Where
- 110 sites in Argentina, Brazil and 21 more
- Volunteers
- 470 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria
This study is a multicenter, randomized, double-blind, parallel-group, positive-controlled phase III study to evaluate the therapeutic equivalence of SYN008 versus omalizumab for injection (Xolair®) in the treatment of CSU…
- Trial name
- NCT04944602
- Testing
- SYN008, Omalizumab for injection
- Volunteers
- 340 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Allergic Asthma
Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children
The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite…
- Trial name
- NCT01328886
- Testing
- Omalizumab
- Where
- 15 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
- Trial name
- NCT05897008
- Testing
- CMAB007, Xolair
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Asthma
Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.
This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma. THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES
- Trial name
- NCT00219323
- Testing
- Omalizumab
- Where
- Japan
- Volunteers
- 133 people
- Sponsor
- Novartis
Asthma
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
- Trial name
- NCT04778137
- Testing
- Omalizumab
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Allergic Asthma, Uncontrolled Moderate to Severe
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled…
- Trial name
- NCT05813470
- Testing
- Omalizumab (CinnaGen), Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
- Where
- 22 sites in Iran
- Volunteers
- 256 people
- Sponsor
- Cinnagen
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.
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
Asthma, Allergies
Impact of Asthma Treatments on Daily Activities
The primary objective of this web-based, cross-sectional study is to assess and compare the ability to sleep, work or go to school, and to participate in leisure activities among subjects who are receiving Xolair treatment and…
- Trial name
- NCT00350376
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Ovation Research Group
Chronic Spontaneous Urticaria
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU)…
- Trial name
- NCT07816328
- Testing
- Remibrutinib, Omalizumab
- Where
- 5 sites in Hong Kong, Japan and 1 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
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
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 Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an…
- Trial name
- NCT00252135
- Volunteers
- 8,023 people
- Sponsor
- Genentech, Inc.