{"id":"omalizumab-xolair","safety":{"commonSideEffects":[{"rate":"45","effect":"Injection site reaction"},{"rate":"15","effect":"Headache"},{"rate":"20","effect":"Upper respiratory tract infection"},{"rate":"8","effect":"Arthralgia"},{"rate":"0.1","effect":"Anaphylaxis"}]},"_chembl":{"chemblId":"CHEMBL1201589","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By sequestering free IgE, omalizumab reduces the activation of mast cells and basophils that would otherwise occur upon allergen exposure. This prevents the release of inflammatory mediators (histamine, tryptase, leukotrienes) that drive allergic and asthmatic responses. The drug effectively dampens the allergic cascade at its initiation point.","oneSentence":"Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing IgE from interacting with high-affinity IgE receptors on mast cells and basophils.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:58:11.747Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe allergic asthma"},{"name":"Chronic idiopathic urticaria"},{"name":"Nasal polyposis"},{"name":"Food allergy (in combination with oral immunotherapy)"}]},"trialDetails":[{"nctId":"NCT04648930","phase":"","title":"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","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-01-27","conditions":"Allergic Rhinitis","enrollment":50},{"nctId":"NCT06042478","phase":"PHASE3","title":"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.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2023-11-15","conditions":"Chronic Spontaneous Urticaria","enrollment":470},{"nctId":"NCT07450170","phase":"","title":"A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China","status":"NOT_YET_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-03-06","conditions":"Chronic Urticaria","enrollment":2500},{"nctId":"NCT07431658","phase":"","title":"Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria","status":"ENROLLING_BY_INVITATION","sponsor":"Istanbul Training and Research Hospital","startDate":"2025-12-01","conditions":"Chronic Spontaneous Urticaria (CSU)","enrollment":116},{"nctId":"NCT07425639","phase":"","title":"ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar","status":"RECRUITING","sponsor":"Celltrion HealthCare France","startDate":"2025-10-02","conditions":"Chronic Spontaneous Urticaria (CSU), Allergic Asthma","enrollment":225},{"nctId":"NCT06929052","phase":"PHASE1","title":"A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.","status":"COMPLETED","sponsor":"Kashiv BioSciences, LLC","startDate":"2025-01-29","conditions":"Healthy Adult Subjects","enrollment":150},{"nctId":"NCT07356713","phase":"PHASE1","title":"A Study to Find a Suitable Dose of Exl-111 for Further Research","status":"RECRUITING","sponsor":"Excellergy Inc.","startDate":"2026-01-08","conditions":"Allergic Disease","enrollment":70},{"nctId":"NCT07059091","phase":"PHASE2","title":"Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2026-02-12","conditions":"Chronic Obstructive Pulmonary Disease (COPD), Allergies","enrollment":334},{"nctId":"NCT06943534","phase":"PHASE2","title":"Omalizumab Weight-Based Dosing Efficacy Trial","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-07-03","conditions":"Allergies, Food Allergy","enrollment":30},{"nctId":"NCT06053801","phase":"","title":"A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2024-02-16","conditions":"Chronic Spontaneous Urticaria","enrollment":55},{"nctId":"NCT06162728","phase":"PHASE1, PHASE2","title":"Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Jasper Therapeutics, Inc.","startDate":"2023-11-29","conditions":"Chronic Spontaneous Urticaria","enrollment":88},{"nctId":"NCT07359430","phase":"","title":"Deep Phenotyping of CIndU","status":"RECRUITING","sponsor":"Centre for Human Drug Research, Netherlands","startDate":"2025-01-21","conditions":"Skin Diseases, Angio-Oedema and/or Urticaria","enrollment":40},{"nctId":"NCT07342803","phase":"PHASE2","title":"Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients","status":"RECRUITING","sponsor":"Longbio Pharma","startDate":"2025-01-25","conditions":"Allergic Asthma","enrollment":200},{"nctId":"NCT03369704","phase":"PHASE3","title":"Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-12-15","conditions":"Seasonal Allergic Rhinitis","enrollment":337},{"nctId":"NCT07328178","phase":"","title":"Analysis of the Role of IgE Proteoforms in Health and Disease","status":"RECRUITING","sponsor":"KU Leuven","startDate":"2025-01-01","conditions":"Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia","enrollment":200},{"nctId":"NCT04583475","phase":"","title":"Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria","status":"COMPLETED","sponsor":"University Hospital, Lille","startDate":"2021-02-25","conditions":"Spontaneous Urticaria, Chronic","enrollment":163},{"nctId":"NCT06228560","phase":"PHASE2","title":"Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment","status":"COMPLETED","sponsor":"Longbio Pharma","startDate":"2024-01-26","conditions":"Chronic Spontaneous Urticaria","enrollment":202},{"nctId":"NCT02570984","phase":"PHASE2","title":"Preventing Asthma in High Risk Kids","status":"ACTIVE_NOT_RECRUITING","sponsor":"Boston Children's Hospital","startDate":"2018-11-27","conditions":"Asthma","enrollment":200},{"nctId":"NCT07246252","phase":"PHASE1","title":"Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects","status":"COMPLETED","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","startDate":"2024-03-28","conditions":"Healthy Volunteers (HV)","enrollment":114},{"nctId":"NCT04361812","phase":"PHASE1","title":"Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection","status":"TERMINATED","sponsor":"BioRay Pharmaceutical Co., Ltd.","startDate":"2020-10-15","conditions":"Similarity of Pharmacokinetics and Safety","enrollment":1},{"nctId":"NCT05626257","phase":"","title":"Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-01-12","conditions":"Chronic Rhinosinusitis With Nasal Polyps","enrollment":135},{"nctId":"NCT06365879","phase":"PHASE3","title":"To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria","status":"RECRUITING","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","startDate":"2024-06-18","conditions":"Chronic Spontaneous Urticaria","enrollment":392},{"nctId":"NCT04998604","phase":"PHASE4","title":"EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2021-09-27","conditions":"Chronic Rhinosinusitis With Nasal Polyps, Asthma","enrollment":360},{"nctId":"NCT06824649","phase":"PHASE4","title":"Biologics in Chronic Rhinosinusitis With Nasal Polyposis","status":"NOT_YET_RECRUITING","sponsor":"Medical University of South Carolina","startDate":"2026-03","conditions":"Chronic Sinusitis, Nasal Polyps","enrollment":504},{"nctId":"NCT04976192","phase":"PHASE3","title":"Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2021-08-30","conditions":"Chronic Urticaria","enrollment":608},{"nctId":"NCT05916937","phase":"PHASE4","title":"Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria","status":"RECRUITING","sponsor":"Simon Francis Thomsen","startDate":"2024-01-12","conditions":"Chronic Spontaneous Urticaria, Chronic Urticaria, Idiopathic","enrollment":40},{"nctId":"NCT03881696","phase":"PHASE3","title":"Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-07-22","conditions":"Peanut Allergy, Multi-food Allergy","enrollment":471},{"nctId":"NCT04180488","phase":"PHASE3","title":"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 CUPID)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2019-12-11","conditions":"Chronic Spontaneous Urticaria","enrollment":397},{"nctId":"NCT07021495","phase":"","title":"SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2025-07-29","conditions":"Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS), Psoriasis (PsO)","enrollment":840},{"nctId":"NCT06261567","phase":"","title":"A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-02-27","conditions":"Asthma","enrollment":415},{"nctId":"NCT06437171","phase":"PHASE4","title":"FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA","status":"ACTIVE_NOT_RECRUITING","sponsor":"AAADRS Clinical Research Center","startDate":"2024-06-03","conditions":"Food Allergy","enrollment":20},{"nctId":"NCT07073404","phase":"","title":"Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin","status":"NOT_YET_RECRUITING","sponsor":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","startDate":"2026-01","conditions":"Food Allergies","enrollment":37},{"nctId":"NCT04480242","phase":"","title":"Asthma Research in Children and Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Parc de Salut Mar","startDate":"2017-07-26","conditions":"Persistent Asthma, Asthma in Children, Asthma Exacerbation","enrollment":525},{"nctId":"NCT04426890","phase":"PHASE3","title":"To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-12-09","conditions":"Chronic Spontaneous Urticaria","enrollment":634},{"nctId":"NCT05332067","phase":"PHASE2","title":"Omalizumab Before Onset of Exacerbations","status":"RECRUITING","sponsor":"Children's National Research Institute","startDate":"2022-05-01","conditions":"Asthma in Children, Atopy, Viral Upper Respiratory Infection","enrollment":300},{"nctId":"NCT07027163","phase":"","title":"A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-06-01","conditions":"Food Hypersensitivity, Anaphylaxis","enrollment":62},{"nctId":"NCT05053334","phase":"PHASE1","title":"Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair","status":"COMPLETED","sponsor":"Syneos Health","startDate":"2022-02-16","conditions":"Healthy Volunteers","enrollment":165},{"nctId":"NCT06934200","phase":"PHASE2","title":"Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2025-05-19","conditions":"Food Hypersensitivity","enrollment":32},{"nctId":"NCT03679676","phase":"PHASE2","title":"Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)","status":"COMPLETED","sponsor":"Stanford University","startDate":"2020-02-05","conditions":"Hypersensitivity, Food Allergy, Hypersensitivity, Food","enrollment":108},{"nctId":"NCT06438757","phase":"PHASE2","title":"Trial of JYB1904 in Patients With Allergic Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Jemincare","startDate":"2024-06-19","conditions":"Allergic Asthma","enrollment":69},{"nctId":"NCT06618963","phase":"PHASE4","title":"Effect of Omalizumab in the Skin of Food Allergy Patients","status":"RECRUITING","sponsor":"National Jewish Health","startDate":"2024-10-01","conditions":"Food Allergy, Food Allergy in Children","enrollment":40},{"nctId":"NCT04833855","phase":"PHASE2","title":"Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria","status":"COMPLETED","sponsor":"Amgen","startDate":"2021-04-15","conditions":"Chronic Spontaneous Urticaria","enrollment":183},{"nctId":"NCT03727971","phase":"PHASE2","title":"Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study.","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2019-01-01","conditions":"Asthma, Infertility, Female","enrollment":66},{"nctId":"NCT06617754","phase":"","title":"International Severe CRSwNP Registry 2024-2028","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vibeke Backer","startDate":"2025-03-31","conditions":"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","enrollment":3000},{"nctId":"NCT06869382","phase":"PHASE4","title":"ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression","status":"COMPLETED","sponsor":"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation","startDate":"2023-01-01","conditions":"Asthma Patients","enrollment":26},{"nctId":"NCT05564611","phase":"PHASE1","title":"PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Kashiv BioSciences, LLC","startDate":"2022-11-04","conditions":"Healthy","enrollment":204},{"nctId":"NCT05774639","phase":"PHASE3","title":"Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria","status":"COMPLETED","sponsor":"Kashiv BioSciences, LLC","startDate":"2023-08-15","conditions":"Chronic Idiopathic Urticaria","enrollment":600},{"nctId":"NCT06806826","phase":"PHASE4","title":"The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study","status":"COMPLETED","sponsor":"Yuzuncu Yil University","startDate":"2019-01-01","conditions":"Allergic Rhinitis","enrollment":50},{"nctId":"NCT05564221","phase":"PHASE1","title":"A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases","status":"COMPLETED","sponsor":"Yuhan Corporation","startDate":"2022-11-01","conditions":"Atopic Healthy Subjects, Adult Subjects With Allergic Diseases","enrollment":46},{"nctId":"NCT06771934","phase":"","title":"Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Qianfoshan Hospital","startDate":"2024-06-01","conditions":"Allergic Asthma","enrollment":60},{"nctId":"NCT03580356","phase":"PHASE3","title":"A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-10-20","conditions":"Chronic Spontaneous Urticaria","enrollment":1078},{"nctId":"NCT05061524","phase":"PHASE1","title":"A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases","status":"COMPLETED","sponsor":"Yuhan Corporation","startDate":"2021-09-26","conditions":"Atopic Healthy Subjects, Adult Subjects with Mild Allergic Diseases","enrollment":68},{"nctId":"NCT06509334","phase":"PHASE2","title":"Trial of JYB1904 in Chronic Spontaneous Urticaria.","status":"RECRUITING","sponsor":"Jemincare","startDate":"2024-08-04","conditions":"Chronic Spontaneous Urticaria","enrollment":135},{"nctId":"NCT04045301","phase":"PHASE2","title":"Omalizumab to Accelerate a Symptom-driven Multi-food OIT","status":"ACTIVE_NOT_RECRUITING","sponsor":"Philippe Bégin","startDate":"2019-11-11","conditions":"Food IgE-mediated Allergy, Immunotherapy, Omalizumab","enrollment":90},{"nctId":"NCT05960708","phase":"PHASE1","title":"A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases","status":"COMPLETED","sponsor":"Yuhan Corporation","startDate":"2023-08-23","conditions":"Allergic Disease, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria","enrollment":30},{"nctId":"NCT06683261","phase":"","title":"Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)","status":"RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2022-09-23","conditions":"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Chronic Rhinosinusitis (CRS)","enrollment":300},{"nctId":"NCT04763447","phase":"PHASE4","title":"Short Treatment with Omalizumab for Severe Asthma","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-05-20","conditions":"Asthma","enrollment":234},{"nctId":"NCT04943744","phase":"EARLY_PHASE1","title":"Gastrointestinal STRING Test With Oral Immunotherapy","status":"TERMINATED","sponsor":"Stanford University","startDate":"2021-05-17","conditions":"Eosinophilic Disorder, Food Allergy","enrollment":13},{"nctId":"NCT04774315","phase":"PHASE4","title":"Molecular Endotypes of Chronic Idiopathic Urticaria","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Colorado, Denver","startDate":"2022-01-01","conditions":"Chronic Urticaria, Idiopathic","enrollment":15},{"nctId":"NCT04583501","phase":"EARLY_PHASE1","title":"Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2020-12-15","conditions":"Chronic Rhinosinusitis With Nasal Polyps, Nasal Polyps","enrollment":21},{"nctId":"NCT06535087","phase":"","title":"The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life","status":"RECRUITING","sponsor":"Wenjing Zhou","startDate":"2024-07-20","conditions":"Pediatric Asthma, Rhinitis, Allergic, Quality of Life","enrollment":600},{"nctId":"NCT06494345","phase":"PHASE1","title":"A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers","status":"COMPLETED","sponsor":"AO GENERIUM","startDate":"2023-01-15","conditions":"Allergic Asthma","enrollment":180},{"nctId":"NCT04128176","phase":"PHASE3","title":"Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid","status":"WITHDRAWN","sponsor":"University of California, Davis","startDate":"2017-03","conditions":"Bullous Pemphigoid","enrollment":""},{"nctId":"NCT06456450","phase":"","title":"Taiwan Severe Asthma Biologic Registry","status":"RECRUITING","sponsor":"Taichung Veterans General Hospital","startDate":"2023-11-11","conditions":"Pulmonary Disease, Asthma","enrollment":500},{"nctId":"NCT05938972","phase":"","title":"Real Life Study of Biologicals in Patients With Severe CRSwNP","status":"RECRUITING","sponsor":"University Hospital, Ghent","startDate":"2022-03-01","conditions":"Chronic Rhinosinusitis With Nasal Polyps","enrollment":180},{"nctId":"NCT06348407","phase":"","title":"A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE)","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2023-12-01","conditions":"Moderate to Severe Allergic Asthma","enrollment":300},{"nctId":"NCT06103656","phase":"PHASE2","title":"E-B-FAHF-2, Multi OIT and Xolair for Food Allergy","status":"COMPLETED","sponsor":"New York Medical College","startDate":"2016-08-20","conditions":"Food Allergy","enrollment":33},{"nctId":"NCT06316414","phase":"","title":"Omalizumab in Severe Asthmatics With Food Allergy","status":"COMPLETED","sponsor":"Bambino Gesù Hospital and Research Institute","startDate":"2018-01-01","conditions":"Food; Allergy, Anaphylactic Shock, Asthma in Children","enrollment":65},{"nctId":"NCT05270278","phase":"","title":"Characteristics of Type 2- High Inflammatory Endotype of Asthma Using New Biomarkers From Peripheral Blood and Exhaled Air and Its Effect on the Outcome of Therapy","status":"COMPLETED","sponsor":"Value Outcomes Ltd.","startDate":"2022-08-16","conditions":"Asthma; Eosinophilic, Asthma Chronic, Bronchial Asthma","enrollment":89},{"nctId":"NCT05972213","phase":"","title":"Phenotypic and Functional Characterization of Neutrophils and Eosinophils in Severe Asthma Treated With Biotherapy","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-07-21","conditions":"Asthma","enrollment":105},{"nctId":"NCT03964051","phase":"PHASE4","title":"Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).","status":"TERMINATED","sponsor":"Carsten Bindslev-Jensen","startDate":"2019-07-01","conditions":"Food Allergy","enrollment":7},{"nctId":"NCT04037176","phase":"PHASE4","title":"Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)","status":"COMPLETED","sponsor":"Carsten Bindslev-Jensen","startDate":"2019-11-01","conditions":"Food Allergy","enrollment":20},{"nctId":"NCT04158050","phase":"","title":"Comparison of Biologicals in Treatment of Severe Asthma","status":"COMPLETED","sponsor":"Helsinki University Central Hospital","startDate":"2018-01-01","conditions":"Asthma","enrollment":64},{"nctId":"NCT06024707","phase":"","title":"Fluctuation Analyses of Asthma Patients With Biologics Use","status":"UNKNOWN","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2023-12","conditions":"Asthma","enrollment":48},{"nctId":"NCT06027073","phase":"PHASE4","title":"Biologics and Sublingual Immunotherapy","status":"NOT_YET_RECRUITING","sponsor":"Medical University of Silesia","startDate":"2024-05-01","conditions":"Asthma, Allergic","enrollment":150},{"nctId":"NCT03580369","phase":"PHASE3","title":"A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-10-17","conditions":"Chronic Spontaneous Urticaria","enrollment":1072},{"nctId":"NCT05413161","phase":"PHASE1","title":"To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects","status":"COMPLETED","sponsor":"Kashiv BioSciences, LLC","startDate":"2022-07-07","conditions":"Healthy","enrollment":306},{"nctId":"NCT05449535","phase":"PHASE1","title":"Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects","status":"COMPLETED","sponsor":"Jemincare","startDate":"2022-05-07","conditions":"Healthy","enrollment":56},{"nctId":"NCT05897008","phase":"PHASE1","title":"The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity","status":"COMPLETED","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","startDate":"2022-02-07","conditions":"Healthy Volunteers","enrollment":114},{"nctId":"NCT04018313","phase":"PHASE1","title":"To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-05-28","conditions":"Healthy","enrollment":176},{"nctId":"NCT05813470","phase":"PHASE3","title":"Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2021-01-18","conditions":"Allergic Asthma, Uncontrolled Moderate to Severe","enrollment":256},{"nctId":"NCT01781637","phase":"PHASE1, PHASE2","title":"Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial","status":"COMPLETED","sponsor":"Boston Children's Hospital","startDate":"2013-01","conditions":"Peanut Allergy, Food Allergy","enrollment":36},{"nctId":"NCT05674695","phase":"","title":"Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy","status":"RECRUITING","sponsor":"Fundación Academia Española de Dermatología","startDate":"2019-01-01","conditions":"Dermatitis, Atopic","enrollment":2500},{"nctId":"NCT00434434","phase":"PHASE2","title":"A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma","status":"COMPLETED","sponsor":"Genentech, Inc.","startDate":"2007-10","conditions":"Allergic Asthma","enrollment":61},{"nctId":"NCT04720612","phase":"PHASE2","title":"COVID-19 Immunologic Antiviral Therapy With Omalizumab","status":"UNKNOWN","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2021-10-15","conditions":"Covid19","enrollment":40},{"nctId":"NCT02966314","phase":"PHASE4","title":"Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2017-03-30","conditions":"Idiopathic Angioedema","enrollment":12},{"nctId":"NCT03476109","phase":"PHASE4","title":"Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.","status":"UNKNOWN","sponsor":"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","startDate":"2019-05-10","conditions":"Severe Asthma","enrollment":100},{"nctId":"NCT05424523","phase":"","title":"Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-02-25","conditions":"Allergic Asthma","enrollment":200},{"nctId":"NCT05405478","phase":"PHASE4","title":"Omalizumab Efficacy in Patients With Refractory Nasal Polyps","status":"UNKNOWN","sponsor":"Shiraz University of Medical Sciences","startDate":"2022-06-01","conditions":"Nasal Polyps","enrollment":2},{"nctId":"NCT05390255","phase":"PHASE3","title":"Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis","status":"UNKNOWN","sponsor":"Beijing Tongren Hospital","startDate":"2022-05-25","conditions":"Sinusitis","enrollment":87},{"nctId":"NCT01716312","phase":"PHASE1","title":"Omalizumab for Lupus","status":"COMPLETED","sponsor":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","startDate":"2014-01-08","conditions":"Systemic Lupus Erthematosus, Sjogren's Syndrome","enrollment":17},{"nctId":"NCT03478930","phase":"PHASE3","title":"An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2018-05-09","conditions":"Nasal Polyps, Chronic Rhinosinusitis","enrollment":249},{"nctId":"NCT04195958","phase":"PHASE4","title":"A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma","status":"TERMINATED","sponsor":"Genentech, Inc.","startDate":"2020-11-30","conditions":"Moderate-to-severe Allergic Asthma","enrollment":3},{"nctId":"NCT05157087","phase":"","title":"XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-03-01","conditions":"Asthma","enrollment":16246},{"nctId":"NCT01460862","phase":"","title":"Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2011-05","conditions":"Asthma","enrollment":""},{"nctId":"NCT05129033","phase":"NA","title":"A Prospective Study on Optimizing Treatment for ABPA","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","startDate":"2021-11-15","conditions":"Allergic Bronchopulmonary Aspergillosis","enrollment":100},{"nctId":"NCT04778137","phase":"PHASE1","title":"The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety","status":"COMPLETED","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","startDate":"2020-12-01","conditions":"Asthma","enrollment":114},{"nctId":"NCT02124226","phase":"PHASE3","title":"Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma","status":"UNKNOWN","sponsor":"Universita degli Studi di Catania","startDate":"2021-12","conditions":"Low Dose Methotrexate in Severe Chronic Asthma","enrollment":102},{"nctId":"NCT04535817","phase":"PHASE1","title":"Xolair Interventional Study in ASD Patients With Comorbid Atopy","status":"WITHDRAWN","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2021-01-01","conditions":"Autism Spectrum Disorder, Atopy","enrollment":""},{"nctId":"NCT05001529","phase":"PHASE4","title":"Flow Cytometry Analysis of Eosinophils in Severe Asthma Patients.","status":"UNKNOWN","sponsor":"Scarlata, Simone, M.D.","startDate":"2021-03-18","conditions":"Severe Asthma","enrollment":80}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ANAEMIA"},{"count":1,"reaction":"ASTHENIA"},{"count":1,"reaction":"BACK PAIN"},{"count":1,"reaction":"BODY TEMPERATURE"},{"count":1,"reaction":"CONFUSIONAL STATE"},{"count":1,"reaction":"GASTRIC ULCER"},{"count":1,"reaction":"HEPATITIS ACUTE"},{"count":1,"reaction":"LETHARGY"},{"count":1,"reaction":"MOVEMENT DISORDER"},{"count":1,"reaction":"MUSCLE SPASMS"}],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Anti IgE","Xolair","Omalizumab 150mg"],"phase":"marketed","status":"active","brandName":"Omalizumab (Xolair)","genericName":"Omalizumab (Xolair)","companyName":"McMaster University","companyId":"mcmaster-university","modality":"Biologic","firstApprovalDate":"","aiSummary":"Omalizumab is a monoclonal antibody that binds to circulating immunoglobulin E (IgE), preventing IgE from interacting with high-affinity IgE receptors on mast cells and basophils. Used for Moderate to severe allergic asthma, Chronic idiopathic urticaria, Nasal polyposis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}