Clinical trials: Omalizumab
Chronic Idiopathic Urticaria
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
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
- NCT01287117
- Testing
- Omalizumab
- Where
- 66 sites in United States, Denmark and 6 more
- Volunteers
- 319 people
- Sponsor
- Genentech, Inc.
Chronic Spontaneous Urticaria
To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria
This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair®…
- Trial name
- NCT06365879
- Testing
- CMAB007, Xolair
- Where
- China
- Volunteers
- 392 people
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Chronic Spontaneous Urticaria
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1…
- Trial name
- NCT06053801
- Testing
- Xolair
- Where
- 10 sites in China
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria, Angioedema
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
- Trial name
- X-ACT (NCT01723072)
- Testing
- Omalizumab
- Where
- 25 sites in Germany
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy…
- Trial name
- NCT04018313
- Testing
- CT-P39, EU-approved Xolair, US-licensed Xolair
- Where
- 2 sites in Australia
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Celltrion
Asthma
XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months
- Trial name
- NCT05157087
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 16,246 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that…
- Trial name
- NCT00267202
- Testing
- Omalizumab, Immunotherapy
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Novartis
Allergic Asthma
The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy
The primary objective is to assess the clinical effectiveness of long-term omalizumab therapy in 240 patients treated over an 8 year period in a real-life clinical setting and to compare the pre- and post-treatment clinical…
- Trial name
- The Reality (NCT01776177)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Joseph D. Diaz, MD
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
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
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.
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
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 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
A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the…
- Trial name
- NCT01703312
- Testing
- QGE031, omalizumab
- Where
- 7 sites in Canada, Sweden
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway…
- Trial name
- AQUA (NCT00434434)
- Testing
- omalizumab
- Volunteers
- 61 people
- Sponsor
- Genentech, Inc.
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.
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
Nasal Polyps, Chronic Rhinosinusitis
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to…
- Trial name
- POLYP 2 (NCT03280537)
- Testing
- Omalizumab
- Where
- 45 sites in United States, Belgium and 8 more
- Volunteers
- 127 people
- Sponsor
- Hoffmann-La Roche
Allergic Asthma
Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab…
- Trial name
- NCT05424523
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals