| Xolair (omalizumab) / Roche, Novartis |
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] | | | | |
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 | | |
| 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 | | |
| 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 | | |
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 | | |
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 | | |
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 | | |
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] | | | | |
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] | | | | |
| 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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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 | | |
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 | | |
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 | | |
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 | | |
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 | | |
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 | | |
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 | | |
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 | | |
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 | | |
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 | | |