Clinical trials: Omalizumab
Food Allergy
Multi Immunotherapy to Test Tolerance and Xolair
This is a phase 2 randomized, double-blind, placebo controlled study which will be conducted at multiple centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (limited to 5 of those…
- Trial name
- M-TAX (NCT02626611)
- Testing
- Omalizumab, Food Flour Buildup
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- Kari Christine Nadeau
Food Allergy, Food Allergy in Children
Effect of Omalizumab in the Skin of Food Allergy Patients
The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC).
- Trial name
- NCT06618963
- Testing
- Omalizumab Injection
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Jewish Health
Nasal Polyposis, Asthma
Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma
This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on…
- Trial name
- NCT01393340
- Testing
- Omalizumab
- Where
- 2 sites in Belgium
- Volunteers
- 23 people
- Sponsor
- University Hospital, Ghent
Gastroenteritis
Omalizumab to Treat Eosinophilic Gastroenteritis
This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG).
- Trial name
- NCT00084097
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Idiopathic Urticaria
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
- Trial name
- NCT01599637
- Testing
- IGE025
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Esophagitis
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults.
- Trial name
- NCT00123630
- Testing
- omalizumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Utah
Cold Contact Urticaria
Cold Urticaria Treatment With Xolair
Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus.
- Trial name
- CUTEX (NCT01580592)
- Testing
- Omalizumab
- Where
- 3 sites in Germany
- Volunteers
- 31 people
- Sponsor
- Charite University, Berlin, Germany
Pulmonary Disease, Chronic Obstructive
Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
The objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces exacerbations in COPD patients; or…
- Trial name
- NCT00851370
- Testing
- Omalizumab (Xolair)
- Where
- United States
- Sponsor
- National Jewish Health
Persistent Allergic Asthma
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite…
- Trial name
- NCT01202903
- Testing
- Omalizumab
- Where
- 39 sites in China
- Volunteers
- 616 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Asthma
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S.
- Trial name
- NCT02023151
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Johns Hopkins University
Atopic Dermatitis
Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients
Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels.
- Trial name
- NCT00822783
- Testing
- Omalizumab
- Where
- Austria
- Sponsor
- Medical University of Vienna
Asthma
Sputum-derived Cellular Targets After Xolair (Omalizumab)
The primary purpose of this study is to identify additional mechanisms of action of omalizumab that will lead to improved stratification of patients for treatment.
- Trial name
- NCT02658877
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- NYU Langone Health
Asthma
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction…
- Trial name
- AERO (NCT00495612)
- Testing
- Omalizumab
- Volunteers
- 69 people
- Sponsor
- Genentech, Inc.
Chronic Urticaria
Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria
Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema.
- Trial name
- NCT01713725
- Testing
- Omalizumab
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Food Allergies
Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin
Omalizumab has demonstrated efficacy, increasing the tolerance threshold in patients with multiple food allergies, as well as reducing the risk of severe reactions when used as monotherapy.
- Trial name
- Omlyclo (NCT07073404)
- Testing
- Omalizumab Injection
- Volunteers
- 37 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Healthy Volunteers
Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland)…
- Trial name
- NAP (NCT04601389)
- Testing
- Omalizumab (JSC "GENERIUM", the Russian Federation), Xolair® (Novartis Pharma AG, Switzerland)
- Where
- 2 sites in Russia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Healthy Adult Subjects
A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference…
- Trial name
- NCT06929052
- Testing
- ADL-018 Autoinjector, ADL-018 Injection
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Allergic Asthma, Uncontrolled Moderate to Severe
Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma
The purpose of this study is to evaluate the efficacy and safety of Omalizumab produced by CinnaGen compared with Xolair® (Genentech, Inc., USA And Novartis Pharmaceuticals Corp, Switzerland) in subjects with uncontrolled…
- Trial name
- NCT05813470
- Testing
- Omalizumab (CinnaGen), Omalizumab (Genentech, Inc., USA and Novartis Pharmaceuticals Corp, Switzerland)
- Where
- 22 sites in Iran
- Volunteers
- 256 people
- Sponsor
- Cinnagen
Sinusitis
Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis
Chronic rhinosinusitis that recurs after adequate surgery and conventional medical treatment is called refractory chronic rhinosinusitis (RCRS).
- Trial name
- NCT05390255
- Testing
- Mometasone furoate nasal spray hormone, Mometasone furoate nasal spray hormone + oral hormone, Mometasone furoate nasal spray hormone + omalizumab
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Beijing Tongren Hospital
Cat Allergy
The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the…
- Trial name
- NCT01003301
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University