| Xolair (omalizumab) / Roche, Novartis |
ACTRN12618000850279: How to "choosebetweenamab" for severe asthma, comparing treatment with mepolizumab and omalizumab for patients with severe allergic and eosinophilic asthma. |
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| Recruiting | 4 | 200 | | | Peter Wark, Glaxo Smith Kline | severe asthma | | | | |
2012-002106-48: An Investigative Study to characterize gene expression patterns in myeloid cells that are triggered during acute asthma exacerbations, and to identify associated genes/gene networks that are Omalizumab sensitive. |
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| Ongoing | 4 | 20 | Europe | Xolair Powder and Solvent for Injection | University College Dublin | Asthma, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
2009-012108-15: Korrelation von freiem IgE mit klinischen Parametern bei Asthma-Patienten unter Therapie mit Omalizumab, einem monoklonalen Antikörper gegen körpereigenes IgE |
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| Ongoing | 4 | 20 | Europe | Xolair 150 mg powder and solvent for solution for injection, Xolair 150 mg powder and solvent for solution for injection | Mainz University Hospital | Add-on therapy to improve asthma control in patients 18-75 years of age with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. | | | | |
2014-005127-27: Mechanism of action of Xolair (omalizumab) as treatment for hives Werkingsmechanisme van omalizumab bij netelroos |
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| Ongoing | 4 | 30 | Europe | Xolair, Xolair | UMC Utrecht, Novartis Pharma | Chronic spontaneous urticaria chronische spontane urticaria | | | | |
ChiCTR2000029142: Efficacy and safety of omalizumab in moderate to severe allergic asthma: a prospective study |
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| Recruiting | 4 | 60 | | Subcutaneous injection of omalizumab ;Conventional treatment | Beijing Institute of Respiratory Medicine; Level of the institution：, Beijing Institute of Respiratory Medicine | moderate to severe allergic asthma | | | | |
| Not yet recruiting | 4 | 234 | Europe | XOLAIR, Solution for injection in pre-filled syringe, XOLAIR | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, Ministère de la Santé et des Solidarités | well controlled severe allergic asthma asthme sévère allergique bien contrôlé, severe allergic asthma asthme sévère allergique, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
2021-000829-27: EVEREST: EValuating trEatment RESponses of dupilumab versus omalizumab in Type 2 patients |
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| Ongoing | 4 | 844 | Europe, RoW | Dupilumab, Omalizumab, SAR231893, Solution for injection in pre-filled syringe, Xolair | Sanofi-aventis Recherche & Développement, Sanofi-aventis Recherche & Développement | Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis with nasal polyps, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
NCT05001529: Flow Cytometry Analysis of Eosinophils in Severe Asthma Patients. |
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| Recruiting | 4 | 80 | Europe | anti IL5 receptor antibodies | Scarlata, Simone, M.D., IRCCS San Raffaele | Severe Asthma | 03/22 | 03/23 | | |
2021-005578-24: Omalizumab’s dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma. Reducción de dosis o aumento de la frecuencia de administración del omalizumab en pacientes con asma alérgica grave no controlada |
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| Ongoing | 4 | 55 | Europe | Solution for infusion in pre-filled syringe, Xolair solución inyectable en jeringa precargada. | Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR), Consorci Mar Parc de Salut de Barcelona | Patients with controlled allergic asthma and under omalizumab treatment for one year. Pacientes con asma alergica controlada y en tratamiento durante un año con omalizumab., Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
NCT04585997: Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab". |
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| Recruiting | 4 | 200 | RoW | Mepolizumab, Nucala, Omalizumab, Xolair | University of Newcastle, Australia, GlaxoSmithKline | Asthma, Eosinophilic Asthma | 06/22 | 12/22 | | |
ACTRN12620001203943: OPAL: Combining Peanut Oral Immunotherapy and Omalizumab in Adults with Peanut Allergy |
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| Active, not recruiting | 4 | 25 | | | St Vincent's Hospital Sydney, SPHERE Triple I, Balnaves Foundation, St Vincent's Curran Fondation | Peanut allergy | | | | |
NCT05405478: Omalizumab Efficacy in Patients With Refractory Nasal Polyps |
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| Not yet recruiting | 4 | 2 | RoW | Omalizumab, XOLAIR, SNOT22 score | Shiraz University of Medical Sciences | Nasal Polyps | 12/22 | 01/23 | | |
ChiCTR2000041572: Prospective randomized controlled clinical trial of the efficacy and safety of omalizumab in the treatment of mild to moderate childhood allergic asthma |
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| Recruiting | 4 | 200 | | Omazumab ;ICS | Guangzhou Women and Children's Medical Center; Guangzhou Women and Children's Medical Center, Research start-up fund of Guangzhou Women and Children Medical Center | Allergic asthma | | | | |
| Terminated | 4 | 7 | Europe | Omalizumab Injection, Xolair 300 mg | Carsten Bindslev-Jensen, Miltenyi Biomedicine GmbH | Food Allergy | 12/20 | 12/20 | | |
| Completed | 4 | 20 | Europe | Omalizumab, Xolair, Placebo, NaCl | Carsten Bindslev-Jensen, Novartis Pharmaceuticals, Thermo Fisher Scientific, Inc | Food Allergy | 03/22 | 03/22 | | |
ChiCTR2100047069: Study on the efficacy and mechanism of ormazumab in the postoperative treatment of patients with chronic rhinosinusitis with nasal polyps combined with asthma in China |
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| Recruiting | 4 | 60 | | standard-of-care (SoC) treatment (Budesonide spray 64ug/side, 2 times) / Day + nasal rinse 1 time / day) 6 months ;SoC treatment plus omalizumab 6 months | Beijing Tongren Hospital, Capital Medical University; Beijing Tongren Hospital, Capital Medical University, Project funding | Chronic rhinosinusitis with nasal polyps | | | | |
| Recruiting | 4 | 100 | Europe | Randomisation to omalizumab, Active-controlled, Randomisation to mepolizumab | Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University Hospital, Ghent, University of Liege, CHU de Charleroi, Erasme University Hospital, Centre Hospitalier Universitaire Dinant Godinne - UCL Namur, Universitair Ziekenhuis Brussel, Brugmann University Hospital, Grand Hôpital de Charleroi, AZ Delta, Centre Hospitalier Universitaire Saint Pierre, KU Leuven | Severe Asthma | 12/23 | 12/24 | | |
NCT06437171: FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA |
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| Recruiting | 4 | 20 | US | Omalizumab | AAADRS Clinical Research Center | Food Allergy | 07/25 | 12/25 | | |
EXOTIC, NCT05916937: Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria |
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| Recruiting | 4 | 40 | Europe | omalizumab 300 mg every four weeks, Standard treatment, omalizumab 300 mg every six weeks, Extended treatment | Simon Francis Thomsen, Aarhus University Hospital | Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic | 12/24 | 06/25 | | |
| Active, not recruiting | 4 | 320 | Europe, Canada, US, RoW | Dupilumab, SAR231893 Dupixent, Omalizumab, Xolair, Placebo | Sanofi, Regeneron Pharmaceuticals | Chronic Rhinosinusitis With Nasal Polyps, Asthma | 10/24 | 01/25 | | |
NCT04774315: Molecular Endotypes of Chronic Idiopathic Urticaria |
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| Active, not recruiting | 4 | 15 | US | Omalizumab | University of Colorado, Denver | Chronic Urticaria, Idiopathic | 03/25 | 03/25 | | |
| Recruiting | 4 | 234 | Europe | Attempt to withdrawal OMA treatment, Continuation of OMA treatment | Assistance Publique - Hôpitaux de Paris | Asthma | 05/25 | 05/25 | | |
| Not yet recruiting | 4 | 150 | NA | omalizumab | Medical University of Silesia, Centrum Medyczne Andrzej Bożek | Asthma, Allergic | 10/26 | 03/28 | | |
ChiCTR2400086969: A real-world study of omalizumab α in the treatment of moderate-to-severe allergic asthma |
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| Not yet recruiting | 4 | 380 | | None | Peking University Third Hospital; Jiangxi Jemincare Medicine Co., LTD, Sponsor self-financing project | Moderate to severe allergic asthma | | | | |
2021-000149-42: A study to compare SYN008 and Xolair for the treatment of chronic urticaria not well controlled by antihistamines |
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| Ongoing | 3 | 480 | Europe | Omalizumab, Xolair, SYN008, Solution for injection in pre-filled syringe, Solution for infusion in pre-filled syringe, Xolair 150 mg solution for injection in pre-filled syringe | Synermore Biologics Co., Ltd, Synermore Biologics Co., Ltd | Chronic spontaneous urticaria (Allergic asthma, Chronic rhinosinusitis with nasal polyps), Asthma, urticaria, Chronic rhinosinusitis, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
2021-001796-17: A Study to Find Out if TEV-45779 Helps to Treat Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria That is Not Helped by Antihistamines Skúšanie na zistenie, či skúšaný produkt TEV-45779 pomáha pri liečbechronickej idiopatickej urtikárie/chronickej spontánnej urtikárie, ktorá nieje podporovaná antihistaminikami |
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| Not yet recruiting | 3 | 600 | Europe, RoW | TEV-45779, XOLAIR, Solution for injection in pre-filled syringe, XOLAIR | Teva Pharmaceuticals, Inc., Teva Pharmaceuticals, Inc. | Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria, Chronic Spontaneous Hives, Diseases [C] - Immune System Diseases [C20] | | | | |
| Completed | 3 | 634 | Europe | CT-P39, Omalizumab, EU-approved Xolair | Celltrion | Chronic Spontaneous Urticaria | 10/22 | 04/23 | | |
NCT05813470: Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma |
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| Completed | 3 | 256 | RoW | Omalizumab (CinnaGen), Zerafil®, Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland), Xolair® | Cinnagen | Allergic Asthma, Uncontrolled Moderate to Severe | 01/23 | 01/23 | | |
2022-001745-20: BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria |
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| Ongoing | 3 | 600 | Europe, RoW | Omalizumab solution for injection in prefilled syringe, Xolair 150 mg solution for injection in pre-filled syringe, BP11, Solution for injection in pre-filled syringe, Xolair 150 mg solution for injection in pre-filled syringe | CuraTeQ Biologics Private Ltd., CuraTeQ Biologics Private Ltd. | Chronic Spontaneous Urticaria, Chronic Urticaria, Diseases [C] - Skin and Connective Tissue Diseases [C17] | | | | |
NCT04944602: Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria |
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| Not yet recruiting | 3 | 340 | NA | SYN008, Omalizumab for injection | CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Chronic Spontaneous Urticaria | 03/23 | 06/23 | | |
NCT04128176: Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid |
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| Withdrawn | 3 | 15 | US | Rituximab combined with Omalizumab, Xolair | University of California, Davis | Bullous Pemphigoid | 05/23 | 11/23 | | |
OUtMATCH, NCT03881696: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants |
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| Active, not recruiting | 3 | 471 | US | Omalizumab, Xolair®, Placebo for Omalizumab, Placebo, Multi-Allergen Oral Immunotherapy, Multi-Allergen OIT, Placebo for Multi-Allergen Oral Immunotherapy, Placebo for Multi-Allergen OIT, Double-Blind Placebo-Controlled Food Challenge Based Treatment, DBPCFC Based Treatment | National Institute of Allergy and Infectious Diseases (NIAID), Genentech, Inc., Novartis Pharmaceuticals, Rho Federal Systems Division, Inc. | Peanut Allergy, Multi-food Allergy | 03/23 | 02/26 | | |
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NCT04976192: Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria |
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| Completed | 3 | 608 | US | TEV-45779, XOLAIR® Injection | Teva Pharmaceuticals USA, Teva Pharmaceuticals Development, Inc. | Chronic Urticaria | 04/24 | 04/24 | | |
CUPID, NCT04180488 / 2019-003775-19: Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU ) |
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| Active, not recruiting | 3 | 397 | Europe, Canada, Japan, US, RoW | Dupilumab SAR231893, Placebo, non sedating H1-antihistamine | Sanofi, Regeneron Pharmaceuticals | Chronic Spontaneous Urticaria | 08/24 | 10/24 | | |
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NCT06365879: To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria |
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| Recruiting | 3 | 392 | RoW | CMAB007, Omalizumab alpha, Xolair, Omalizumab | Taizhou Mabtech Pharmaceutical Co.,Ltd | Chronic Spontaneous Urticaria | 11/25 | 05/26 | | |
NCT05390255: Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis |
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| Recruiting | 3 | 87 | RoW | Mometasone furoate nasal spray hormone, Mometasone furoate nasal spray hormone + oral hormone, Mometasone furoate nasal spray hormone + omalizumab | Beijing Tongren Hospital, Peking Union Medical College Hospital, Beijing Hospital | Sinusitis | 12/24 | 12/24 | | |
NCT05774639: Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria |
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| Recruiting | 3 | 600 | US, RoW | Omalizumab Injection, ADL-018, Xolair Prefilled Syringe | Kashiv BioSciences, LLC, COD Research Private Ltd | Chronic Idiopathic Urticaria | 12/24 | 04/25 | | |
NCT06042478: 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. |
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| Recruiting | 3 | 468 | Europe, Canada, RoW | Remibrutinib, Placebo to remibrutinib, Placebo to omalizumab, Omalizumab | Novartis Pharmaceuticals | Chronic Spontaneous Urticaria | 08/25 | 03/27 | | |
NCT02062814: A Phase 2 Randomized, Controlled, Blinded Study Omalizumab With Oral Food Immunotherapy in Children and Adults With Multiple Food Allergies |
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| Active, not recruiting | 2 | 60 | US | omalizumab, xolair, Placebo | Stanford University | Immune System Disease | 02/17 | 02/17 | | |
2019-002452-16: Medication for inhibition of activation of a certain immune cell in atherosclerotic lesions |
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| Not yet recruiting | 2 | 80 | Europe | Solution for injection, Omalizumab (Xolair®) | UMC Utrecht, University Medical Centre (UMC) Utrecht, Leiden University, Centre for Human Drug Research (CHDR), ZonW, Dutch Heart Foundation | Atherosclerosis Atherosclerose, A disease of the arteries characterized by the deposition of fatty material beneath their inner walls Een ziekte van de slagaderen waarbij vettig materiaal zich op hoopt onder de binnenwand van de slagader., Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| Completed | 2 | 33 | NA | Drug: Chinese Herbal Medication, E-B-FAFH-2, Drug: Placebo, Placebo Chinese Herb, Drug: Omalizumab, Xolair® | New York Medical College, Icahn School of Medicine at Mount Sinai | Food Allergy | 07/20 | 02/21 | | |
2021-002609-93: Rilzabrutinib for the treatment of chronic spontaneous urticaria in patients who remain symptomatic despite the use of H1 antihistamine and who are naïve to omalizumab Rilzabrutinib para el tratamiento de la urticaria crónica espontánea en pacientes que siguen sintomáticos a pesar del uso de antihistamínicos H1 y sin tratamiento previo con omalizumab |
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| Ongoing | 2 | 213 | Europe | Rilzabrutinib, SAR444671, Tablet | Sanofi aventis recherche et developpement, Sanofi Aventis Recherche et Developpement | Chronic spontaneous urticaria Urticaria crónica espontánea, Chronic spontaneous urticaria Urticaria crónica espontánea, Diseases [C] - Skin and Connective Tissue Diseases [C17] | | | | |
| Active, not recruiting | 2 | 40 | Canada | Omalizumab, Xolair, Placebo | McGill University Health Centre/Research Institute of the McGill University Health Centre | Covid19 | 11/22 | 12/22 | | |
| Completed | 2 | 183 | Europe, Canada, Japan, US, RoW | Tezepelumab Dose 1, AMG 157, Tezepelumab Dose 2, Omalizumab, Xolair, Placebo | Amgen | Chronic Spontaneous Urticaria | 12/22 | 04/23 | | |
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| Recruiting | 2 | 90 | Canada | Omalizumab 16mg/kg, Omalizumab 8mg/kg, Placebo, Multi-food oral immunotherapy (OIT) | Philippe Bégin, The Hospital for Sick Children, Centre hospitalier de l'Université de Montréal (CHUM), Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Food IgE-mediated Allergy, Immunotherapy, Omalizumab, Physiological Effects of Drugs | 12/24 | 03/25 | | |
PRO_ART, NCT03727971: Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study. |
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| Active, not recruiting | 2 | 66 | Europe | Omalizumab Injection, NaCl | Rigshospitalet, Denmark, Novartis, Hvidovre University Hospital, Herlev Hospital, Zealand University Hospital | Asthma, Infertility, Female | 12/23 | 12/29 | | |
NCT03679676: Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE) |
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| Active, not recruiting | 2 | 108 | US | Omalizumab, Xolair, Dupilumab, Dupixent, Placebo | Stanford University, National Institute of Allergy and Infectious Diseases (NIAID), Food Allergy Research & Education, Harvard School of Public Health (HSPH) | Hypersensitivity, Food Allergy, Hypersensitivity, Food, Peanut Hypersensitivity, Peanut Allergy | 06/25 | 09/25 | | |
NCT06228560: Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment |
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| Recruiting | 2 | 200 | RoW | LP-003, Placebo, Omalizumab | Longbio Pharma | Chronic Spontaneous Urticaria | 01/25 | 01/25 | | |
NCT06438757: Trial of JYB1904 in Patients With Allergic Asthma |
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| Recruiting | 2 | 60 | RoW | JYB1904, Omalizumab | Jemincare | Allergic Asthma | 10/25 | 10/25 | | |
NCT06509334: Trial of JYB1904 in Chronic Spontaneous Urticaria. |
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| Not yet recruiting | 2 | 135 | RoW | JYB1904, Omalizumab | Jemincare | Chronic Spontaneous Urticaria | 07/26 | 07/26 | | |
| Recruiting | 2 | 300 | US | Omalizumab, Xolair, Placebo, Placebo for omalizumab | Stephen J. Teach, MD, MPH, National Institute of Allergy and Infectious Diseases (NIAID) | Asthma in Children, Atopy, Viral Upper Respiratory Infection | 06/25 | 03/28 | | |
| Active, not recruiting | 2 | 200 | US | Omalizumab, Xolair, Placebo, placebo arm | Boston Children's Hospital, National Institute of Allergy and Infectious Diseases (NIAID) | Asthma | 01/28 | 03/28 | | |
| Completed | 1/2 | 36 | US | Omalizumab, Xolair, placebo | Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University, Ann & Robert H Lurie Children's Hospital of Chicago | Peanut Allergy, Food Allergy | 10/15 | 05/22 | | |
2009-014582-51: Pilot study - sequential combination therapy using selective immunoglobulin apheresis and omalizumab in patients with severe atopic dermatitis and elevated total IgE levels |
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| Ongoing | 1/2 | 10 | Europe | Xolair, Xolair-H-C-606-II-18, Omalizumab, Omalizumab | Faculty of Medicine, Technische Universität München | Patients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis) | | | | |
BEACON, NCT06162728: Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) |
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| Recruiting | 1/2 | 52 | Europe, US | Briquilimab, JSP191, Placebo | Jasper Therapeutics, Inc. | Chronic Spontaneous Urticaria | 10/25 | 10/25 | | |
ChiCTR2000031925: A multicenter, randomized, double-blind, parallel controlled phase I clinical trial comparing the pharmacokinetic and safety similarities of recombinant anti IgE humanized monoclonal antibody for injection(HS632) with Omalizumab (Xolair?)after a single dose administration in Chinese healthy subjects |
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| Not yet recruiting | 1 | 252 | | Subcutaneous injection of HS632 ;Subcutaneous injection of Omazumab | Huashan Hospital Affiliated to Fudan University; Shanghai Shuguang Hospital, Zhejiang Hisunbioray biopharmaceutical Co., Ltd. | Asthma | | | | |
NCT04361812: Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection |
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| Not yet recruiting | 1 | 60 | RoW | HS632, Recombinant anti IgE humanized monoclonal antibody 150mg, Omalizumab (Xolair®), Omalizumab 150mg | Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.Ltd | Similarity of Pharmacokinetics and Safety | 12/21 | 12/21 | | |
NCT05897008: The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity |
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| Completed | 1 | 114 | RoW | CMAB007, Xolair | Taizhou Mabtech Pharmaceutical Co.,Ltd | Healthy Volunteers | 06/22 | 09/22 | | |
ChiCTR2100047781: Phase i, single-center, randomized, double-blind, parallelity-controlled clinical trial comparing pharmacokinetic and safety comparability of recombinant anti-IgE humanized monoclonal antibody for injection (HS632) with omalizumab( Xolair) after single dose administration in healthy Chinese subjects |
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| Not yet recruiting | 1 | 62 | | Subcutaneous injection of HS632 ;Subcutaneous injection of Omazumab | The First Affiliated Hospital of Guangzhou University of Chinese Medicine; Zhejiang haizheng pharmaceutical co. LTD, self-raised | Asthma | | | | |
NCT05449535: Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects |
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| Completed | 1 | 56 | RoW | JYB1904, Omalizumab, Xolair, JYB1904 Placebo | Jemincare | Healthy | 01/23 | 01/23 | | |
OMA-COMP-I, NCT06494345: A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers |
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| Completed | 1 | 180 | RoW | Genolair, solution for subcutaneous administration, 150 mg, Omalizumab biosimilar solution, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Omalizumab biosimilar lyophilisate, Xolair®, solution for subcutaneous administration, 150 mg, Omalizumab solution | AO GENERIUM | Allergic Asthma | 06/24 | 06/24 | | |
NCT05413161: To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects |
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| Completed | 1 | 306 | RoW | ADL-018, US-licensed XOLAIR, EU-Approved XOLAIR | Kashiv BioSciences, LLC | Healthy | 02/23 | 06/23 | | |
NCT05564611: PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects |
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| Recruiting | 1 | 204 | RoW | Omalizumab 150mg, ADL-018 | Kashiv BioSciences, LLC | Healthy | 07/23 | 08/23 | | |
NCT05053334: Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair |
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| Completed | 1 | 165 | RoW | Omalizumab Prefilled Syringe | Syneos Health, CuraTeQ Biologics Private Ltd. | Healthy Volunteers | 11/23 | 11/23 | | |
CRSwNP, NCT04583501: Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis |
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| Completed | 1 | 21 | US | Omalizumab | Johns Hopkins University, Genentech, Inc. | Chronic Rhinosinusitis With Nasal Polyps, Nasal Polyps | 07/24 | 07/24 | | |
| Terminated | 1 | 13 | US | Entero-tracker, omalizumab, dupliumab | Stanford University | Eosinophilic Disorder, Food Allergy | 05/24 | 05/24 | | |
NCT05564221: A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases |
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| Active, not recruiting | 1 | 46 | RoW | YH35324, Placebo, Omalizumab, Xolair® prefilled syringe 150 for injection | Yuhan Corporation | Atopic Healthy Subjects, Adult Subjects With Allergic Diseases | 12/24 | 12/24 | | |
NCT05960708: A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases |
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| Completed | 1 | 30 | RoW | YH35324, Omalizumab, Xolair® prefilled syringe 150 for injection, Placebo | Yuhan Corporation | Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Cold Urticaria | 09/24 | 09/24 | | |
| Completed | N/A | 65 | Europe | Omalizumab | Bambino Gesù Hospital and Research Institute | Food; Allergy, Anaphylactic Shock, Asthma in Children | 03/23 | 03/23 | | |
ChiCTR1900024869: Omalizumab effects and markers of response in patients with urticarial vasculitis |
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| Completed | N/A | 20 | | omalizumab injection | Department of Dermatology and Venereology, Peking University First Hospital; Peking University First Hospital, GZ901 | urticarial vasculitis | | | | |
ChiCTR2000038085: Omalizumab treatment in patients with antihistamines-refractory chronic urticaria: a real-world study in China |
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| Completed | N/A | 90 | | omalizumab | Department of Dermatology and Venereology, Peking University First Hospital; Peking University First Hospital, Self raising by department | chronic urticaria | | | | |
NCT04060550: Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum |
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| Recruiting | N/A | 36 | US | Xolair, omalizumab | National Jewish Health, Genentech, Inc. | Atopic Dermatitis With a History of Eczema Herpeticum, Atopic Dermatitis Without a History of Eczema Herpeticum, Health Controls Without Atopy | 07/21 | 07/21 | | |
ChiCTR2200056599: A real-world study of Omalizumab in the treatment of chronic urticaria in China |
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| Completed | N/A | 259 | | None | Dermatology Hospital, Chinese Academy of Medical Sciences; Dermatology Hospital, Chinese Academy of Medical Sciences, self-funded | chronic urticaria | | | | |
ChiCTR1900021437: Clinical study for omalizumab in the treatment of hereditary bullous epidermolysis |
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| Not yet recruiting | N/A | 20 | | Omabizumab subcutaneous injection | Xinhua Hospital, Shanghai Jiaotong University School of Medicine; Xinhua Hospital, Shanghai Jiaotong University School of Medicine, self-financing | inherited epidermolysis bullosa | | | | |
ChiCTR1900026575: Efficacy of omalizumab in patients with chronic sinusitis and nasal polyps combined with asthma |
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| Recruiting | N/A | 28 | | Omalizumab intramuscular injection ;Nasal Exhaled Corticosteroid Mometasone furoate | Beijing Tongren Hospital; Beijing Tongren Hospital, Beijing Natural Science Fund | Nasal polyps, Asthma | | | | |
ChiCTR2000033374: Effect of Omazumab on intestinal flora in patients with chronic idiopathic urticaria |
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| Not yet recruiting | N/A | 30 | | Omalizumab on Intestinal Flora | Tianjin First Central Hospital; Level of the institution：, Raise independently | Chronic Idiopathic Urticaria | | | | |
ChiCTR2100053813: Efficacy and safety of omalizumab in children with moderate to severe allergic asthma with allergic rhinitis, adenoid hypertrophy and OSAS: a retrospective study based on medical records |
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| Recruiting | N/A | 30 | | Nil | Peking University First Hospital; Peking University First Hospital, Post-approval safety study of Juule (omalizumab) 150mg s.c. injection in Chinese patients with moderate to severe allergic asthma (>=6 years old) (Subject No. 5007601); PFOS regulates GSK-3β phosphory | Moderate to severe allergic asthma; allergic rhinitis; adenoid hypertrophy; obstructive sleep apnea | | | | |
| Recruiting | N/A | 50 | US | | National Jewish Health | Asthma | 07/22 | 07/23 | | |
NCT04665141: Similarities and Differences of Biological Therapies for Severe Asthma. |
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| Recruiting | N/A | 600 | Europe | Mepolizumab, Nucala®, Omalizumab, Xolair®, Reslizumab, Cinqair®, Benralizumab, Fasenra®, Dupilumab, Dupixent® | Clinica Universidad de Navarra, Universidad de Navarra, Hospital Clinic of Barcelona, Hospital Regional de Malaga | Asthma | 11/22 | 11/22 | | |
NCT04648930: 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 |
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| Completed | N/A | 50 | Japan | Xolair, Omalizumab | Novartis Pharmaceuticals | Allergic Rhinitis | 11/22 | 11/22 | | |
INTENXO, NCT04583475: Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria |
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| Recruiting | N/A | 150 | Europe | | University Hospital, Lille | Spontaneous Urticaria, Chronic | 03/23 | 03/23 | | |
ChiCTR2100046343: Screening of predictive indicators of the efficacy of omalizumab in patients with moderate to severe refractory asthma |
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| Recruiting | N/A | 200 | | Nil | the Fifth Affiliated Hospital of Sun Yat-Sen University; the Fifth Affiliated Hospital of Sun Yat-Sen University, self-raised | asthma | | | | |
NCT05129033: A Prospective Study on Optimizing Treatment for ABPA |
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| Not yet recruiting | N/A | 100 | NA | Prednisone tablet, itraconazole, Omalizumab | Shanghai Zhongshan Hospital | Allergic Bronchopulmonary Aspergillosis | 06/23 | 12/23 | | |
| Recruiting | N/A | 500 | RoW | Biological Treatment for severe asthma patients, Omalizumab, Mepolizumab, Benralizumab, Dupilzumab, Tezepelumab | Taichung Veterans General Hospital, E-DA Hospital, National Cheng-Kung University Hospital, National Yang Ming Chiao Tung University Hospital, Chang Gung Memorial Hospital | Pulmonary Disease, Asthma | 02/43 | 02/43 | | |
| Recruiting | N/A | 300 | RoW | IgE monoclonal antibody | The First Affiliated Hospital with Nanjing Medical University | Moderate to Severe Allergic Asthma | 11/24 | 11/24 | | |
| Recruiting | N/A | 180 | Europe | Mepolizumab, Omalizumab, Dupilumab | University Hospital, Ghent | Chronic Rhinosinusitis With Nasal Polyps | 12/30 | 12/30 | | |
NCT06535087: The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life |
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| Recruiting | N/A | 600 | RoW | Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis, Alutard, Antergen, Xolair, Pulmicort, Bricanyl, Singulair, Zyrtec | Wenjing Zhou | Pediatric Asthma, Rhinitis, Allergic, Quality of Life | 06/25 | 05/27 | | |
| Not yet recruiting | N/A | 48 | NA | Biological Drug, Mepolizumab, Omalizumab, Benralizumab, Dupilimab, Reslizumab | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Asthma | 09/24 | 09/24 | | |
NCT05626257: Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps |
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| Recruiting | N/A | 112 | RoW | Xolair | Novartis Pharmaceuticals | Chronic Rhinosinusitis With Nasal Polyps | 01/25 | 01/25 | | |
NCT06053801: A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China |
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| Recruiting | N/A | 59 | RoW | Xolair, Omalizumab | Novartis Pharmaceuticals | Chronic Spontaneous Urticaria | 12/27 | 12/27 | | |
ChiCTR2200065165: Study of the Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Children with Refractory Asthma |
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| Not yet recruiting | N/A | 48 | | Salmeterol Xinafoate and Fluticasone Propionate Powder for inhalation /Fluticasone Propionate Inhaled Aerosol/Budesonide and Formoterol Fumarate Powder for Inhalation and Montelukast Sodium Chewable Tablets ;Salmeterol Xinafoate and Fluticasone Propionate Powder for inhalation /Fluticasone Propionate Inhaled Aerosol/Budesonide and Formoterol Fumarate Powder for Inhalation 、Montelukast Sodium Chewable Tablets and Omalizumab for Injection ;Salmeterol Xinafoate and Fluticasone Propionate Powder for inhalation /Fluticasone Propionate Inhaled Aerosol/Budesonide and Formoterol Fumarate Powder for Inhalation 、Montelukast Sodium Chewable Tablets and Fecal Microbiota Transplantation | Department of Pediatrics, Xijing Hospital, The Air Force Medical University; Xijing Hospital, Xijing Hospital to boost the project | Refractory Asthma | | | | |
ACTRN12616000977471: A clinical trial in children presenting to hospital with an asthma attack, to compare the effectiveness of giving the additional treatment of anti-immunoglobulin E antibody or nothing on the time until their next asthma attack. |
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| Not yet recruiting | N/A | 128 | | | The University of Western Australia, National Health and Medical Research Council, Novartis | asthma exacerbations | | | | |
| Recruiting | N/A | 700 | Europe | | University Hospital, Montpellier, Lyon Civil Hospitals - Lyon Sud Hospital Center, Tenon Hospital, Paris, Nantes University Hospital, University Hospital, Grenoble, University Hospital, Rouen, Lille University Hospital, University Hospital, Bordeaux, Centre Hospitalier Universitaire de Saint Etienne | Chronic Urticaria | 11/20 | 12/20 | | |
| Recruiting | N/A | 2500 | Europe | Ciclosporin, Methotrexate, Dupilumab, Corticosteroids, Omalizumab, Baricitinib, Upadacitinib, Tralokimumab, Topical corticosteroids | Fundación Academia Española de Dermatología | Dermatitis, Atopic | 01/29 | 01/29 | | |