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
Persistent Allergic Asthma
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite…
- Trial name
- NCT01202903
- Testing
- Omalizumab
- Where
- 39 sites in China
- Volunteers
- 616 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction…
- Trial name
- AERO (NCT00495612)
- Testing
- Omalizumab
- Volunteers
- 69 people
- Sponsor
- Genentech, Inc.
Healthy Volunteers
Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland)…
- Trial name
- NAP (NCT04601389)
- Testing
- Omalizumab (JSC "GENERIUM", the Russian Federation), Xolair® (Novartis Pharma AG, Switzerland)
- Where
- 2 sites in Russia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Healthy Adult Subjects
A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference…
- Trial name
- NCT06929052
- Testing
- ADL-018 Autoinjector, ADL-018 Injection
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
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
Healthy, Asthma
The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy…
- Trial name
- NCT00777764
- Testing
- Cohort I, Cohort 2
- Volunteers
- 60 people
- Sponsor
- Genentech, Inc.
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
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
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
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
Asthma
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.
- Trial name
- NCT00482248
- Testing
- Omalizumab
- Volunteers
- 132 people
- Sponsor
- Novartis
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.
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
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe…
- Trial name
- NATAIR (NCT01007149)
- Testing
- omalizumab
- Where
- 10 sites in France
- Volunteers
- 79 people
- Sponsor
- Novartis Pharmaceuticals
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 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
Chronic Spontaneous Urticaria
Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.
- Trial name
- BEACON (NCT06162728)
- Testing
- Briquilimab
- Where
- 23 sites in United States, Germany
- Volunteers
- 87 people
- Sponsor
- Jasper Therapeutics, Inc.
Moderate-to-severe Allergic Asthma
A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
This study will assess the effect of omalizumab on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma.
- Trial name
- EDURO (NCT04195958)
- Testing
- Omalizumab
- Where
- 12 sites in United States
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
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