150 completed, 22 unknown, 16 recruiting, 11 terminated. 57 Phase 2, 55 Phase 4, 49 Phase 3, 26 Phase 1, 11 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy Omalizumab - Food Allergy | Phase 4 | Not yet recruiting | Johns Hopkins University | 20 | 2026-10-01 | 2026-10-14 |
| Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks Remibrutinib, Omalizumab - Chronic Spontaneous Urticaria | Phase 3 | Recruiting | Novartis Pharmaceuticals | 382 | 2026-09-21 | 2026-10-13 |
| Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD Omalizumab (Xolair®), Sodium Chloride (NaCl) 0.9 % - Chronic Obstructive Pulmonary Disease (COPD), Allergies | Phase 2 | Recruiting | Johns Hopkins University | 334 | 2026-02-12 | 2026-09-04 |
| A Study to Find a Suitable Dose of Exl-111 for Further Research Exl-111 (SAD), Exl-111 (MAD), Placebo - Allergic Disease | Phase 1 | Recruiting | Excellergy Inc. | 70 | 2026-01-08 | 2026-09-22 |
| Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin Omalizumab Injection - Food Allergies | Not yet recruiting | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | 37 | 2026-01-01 | 2025-08-12 | |
| ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar Omalizumab - Chronic Spontaneous Urticaria (CSU), Allergic Asthma | Recruiting | Celltrion HealthCare France | 225 | 2025-10-02 | 2026-02-23 | |
| Omalizumab Weight-Based Dosing Efficacy Trial 5mg/kg omalizumab injection, 15mg/kg omalizumab injection - Allergies, Food Allergy | Phase 2 | Recruiting | Massachusetts General Hospital | 30 | 2025-07-03 | 2026-02-05 |
| Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels Omalizumab - Food Hypersensitivity | Phase 2 | Recruiting | Johns Hopkins University | 32 | 2025-05-19 | 2026-06-08 |
| Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients LP-003 Injection, Omalizumab, Placebo - Allergic Asthma | Phase 2 | Recruiting | Longbio Pharma | 200 | 2025-01-25 | 2026-01-15 |
| Effect of Omalizumab in the Skin of Food Allergy Patients Omalizumab Injection - Food Allergy, Food Allergy in Children | Phase 4 | Recruiting | National Jewish Health | 40 | 2024-10-01 | 2025-05-02 |
| Trial of JYB1904 in Chronic Spontaneous Urticaria. JYB1904, Omalizumab - Chronic Spontaneous Urticaria | Phase 2 | Recruiting | Jemincare | 135 | 2024-08-04 | 2024-11-29 |
| The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis - Pediatric Asthma, Rhinitis, Allergic | Recruiting | Wenjing Zhou | 600 | 2024-07-20 | 2024-08-02 | |
| Trial of JYB1904 in Patients With Allergic Asthma JYB1904, Omalizumab - Allergic Asthma | Phase 2 | Completed | Jemincare | 69 | 2024-06-19 | 2026-06-15 |
| To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria CMAB007, Xolair - Chronic Spontaneous Urticaria | Phase 3 | Completed | Taizhou Mabtech Pharmaceutical Co.,Ltd | 392 | 2024-06-18 | 2026-10-02 |
| FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA Omalizumab - Food Allergy | Phase 4 | Active not recruiting | AAADRS Clinical Research Center | 20 | 2024-06-03 | 2025-08-14 |
| Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma Allergen-specific immunotherapy(AIT), omalizumab - Allergic Asthma | Unknown | Qianfoshan Hospital | 60 | 2024-06-01 | 2025-01-13 | |
| Biologics and Sublingual Immunotherapy omalizumab - Asthma, Allergic | Phase 4 | Not yet recruiting | Medical University of Silesia | 150 | 2024-05-01 | 2023-09-07 |
| Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects Process-Changed CMAB007, Xolair (omalizumab) - Healthy Volunteers (HV) | Phase 1 | Completed | Taizhou Mabtech Pharmaceutical Co.,Ltd | 114 | 2024-03-28 | 2025-11-24 |
| A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China Xolair - Chronic Spontaneous Urticaria | Completed | Novartis Pharmaceuticals | 55 | 2024-02-16 | 2026-02-04 | |
| Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment LP-003, Placebo, Omalizumab - Chronic Spontaneous Urticaria | Phase 2 | Completed | Longbio Pharma | 202 | 2024-01-26 | 2026-10-21 |
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Asthma (67) · Chronic Urticaria (34) · Hypersensitivity (23) · Food Hypersensitivity (18) · Urticaria (11) · Dermatitis, Atopic (8) · Nasal Polyps (8) · Peanut Hypersensitivity (8) · Rhinitis, Allergic (8) · Epilepsy, Idiopathic Generalized (6) · Anaphylaxis (4) · Angioedema (4) · Immune System Diseases (4) · Lung Diseases (4) · Rhinitis, Allergic, Seasonal (4)
Novartis Pharmaceuticals (30) · Genentech, Inc. (18) · Novartis (12) · Johns Hopkins University (11) · National Institute of Allergy and Infectious Diseases (NIAID) (8) · Stanford University (5) · Creighton University (4) · Hoffmann-La Roche (4) · Taizhou Mabtech Pharmaceutical Co.,Ltd (4) · AO GENERIUM (3) · Boston Children's Hospital (3) · Clinica Universidad de Navarra, Universidad de Navarra (3) · Jemincare (3) · National Jewish Health (3) · University of Mississippi Medical Center (3)
United States (101) · Germany (25) · China (18) · France (17) · Canada (16) · Spain (16) · Poland (14) · United Kingdom (12) · Italy (11) · Belgium (10) · Russia (10) · South Korea (10) · Denmark (9) · Japan (9) · Mexico (9)
Jacqueline Pongracic, MD (3) · Robert G Townley, MD (3) · Sarbjit Saini, MD (3) · Dennis Wong, M.D. (2) · Gailen D. Marshall, MD/PhD (2) · Hae-Sim Park (2) · Kari Nadeau, MD, PhD (2) · Karin Rosen, M.D., Ph.D. (2) · Martin Metz, MD (2) · Oksana A Markova, MD (2) · Rebecca S. Gruchalla, MD, PhD (2)
PMID 26054553, PMID 27424128, PMID 27540466, PMID 27939380, PMID 28390587, PMID 29655772, PMID 31760132, PMID 32298853, PMID 33223095, PMID 33465457, PMID 33710614, PMID 37951571, PMID 38197558, PMID 33217063, PMID 33548517, PMID 34382434, PMID 37214171, PMID 38008109, PMID 38407394, PMID 39193419, PMID 39309477, PMID 14619332, PMID 16387596, PMID 17631952, PMID 19910033, PMID 20004787, PMID 20801010, PMID 21038023, PMID 21410369, PMID 21527026, PMID 21536936, PMID 21668817, PMID 21762974, PMID 21933100, PMID 22318492, PMID 23432142, PMID 23471469, PMID 23579324, PMID 23791510, PMID 23816920, PMID 24028677, PMID 24657236, PMID 24907494, PMID 25046337, PMID 25528738, PMID 25609353, PMID 25789989, PMID 26302738, PMID 26433533, PMID 26518090
2017 (4), 2018 (3), U19AI070345 (3), 2009 (2), U19AI104209 (2), 2014 (1), 2015 (1), R01AI116658 (1), R01HL044253 (1), U01AI100799 (1), U01AI160090 (1), U01AI177195 (1), U01AI179563 (1), U19AI044236 (1)