Clinical trials: Omalizumab
Chronic Rhinosinusitis With Nasal Polyps
Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps
This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.
- Trial name
- NCT05626257
- Testing
- Xolair
- Where
- 16 sites in South Korea
- Volunteers
- 135 people
- Sponsor
- Novartis Pharmaceuticals
Peanut Hypersensitivity
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the…
- Trial name
- NCT00382148
- Testing
- omalizumab
- Volunteers
- 11 people
- Sponsor
- Genentech, Inc.
Allergic Asthma
A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair.
- Trial name
- XPORT (NCT01125748)
- Testing
- Omalizumab, Asthma therapies
- Where
- 100 sites in United States
- Volunteers
- 176 people
- Sponsor
- Genentech, Inc.
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
Asthma
An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g.
- Trial name
- NCT00109187
- Testing
- Xolair (omalizumab)
- 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
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
Bronchial Asthma
An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma
This is a randomized, double-blind, comparative, parallel-group study of the efficacy and safety of Genolar® and Xolair® in the treatment of persistent atopic bronchial asthma of moderate and severe course, whose symptoms are…
- Trial name
- NAP (NCT04607629)
- Testing
- Genolar® + Symbicort®, Xolair® + Symbicort®
- Where
- 24 sites in Russia
- Volunteers
- 192 people
- Sponsor
- AO GENERIUM
Asthma
An Observational Study of the Use and Safety of Xolair® During Pregnancy
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®.
- Trial name
- EXPECT (NCT00373061)
- Testing
- Xolair®
- Where
- United States
- Volunteers
- 309 people
- Sponsor
- Genentech, Inc.
Asthma
Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations
A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled…
- Trial name
- NCT01460862
- 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
Allergic Asthma
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.
- Trial name
- NCT00396409
- Testing
- Depigoid, Omalizumab
- Where
- Germany
- Volunteers
- 128 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Rhinitis
Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies
This was a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic…
- Trial name
- NCT04648930
- Testing
- Xolair
- Volunteers
- 50 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.
Healthy
PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects
This will be a randomized, double blind, two-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.
- Trial name
- NCT05564611
- Testing
- Omalizumab 150mg
- Where
- India
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Chronic Idiopathic Urticaria
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01264939
- Testing
- Omalizumab, H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist, Diphenhydramine
- Where
- 73 sites in United States, Australia and 6 more
- Volunteers
- 336 people
- Sponsor
- Genentech, Inc.
Asthma
Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
This study investigated asthma-related quality of life in Brazilian patients using omalizumab.
- Trial name
- NCT00567476
- Testing
- Omalizumab, Inhaled corticosteroids (ICS), Long-acting beta 2-adrenergic agonist (LABA)
- Where
- Brazil
- Volunteers
- 116 people
- Sponsor
- Novartis
Urticaria
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine…
- Trial name
- NCT02392624
- Testing
- Omalizumab
- Where
- 40 sites in United States
- Volunteers
- 206 people
- Sponsor
- Genentech, Inc.
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.
Asthma
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to…
- Trial name
- NCT00639691
- Testing
- omalizumab
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Novartis