Clinical trials: Omalizumab
Allergic Bronchopulmonary Aspergillosis
A Prospective Study on Optimizing Treatment for ABPA
This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA.
- Trial name
- NCT05129033
- Testing
- Prednisone tablet, itraconazole, Omalizumab
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Healthy Volunteers
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
- Trial name
- NCT05897008
- Testing
- CMAB007, Xolair
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
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
Healthy Volunteers (HV)
Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, safety and immunogenicity of two formulations of Omalizumab (Process-Changed CMAB007 and Xolair) in healthy subjects.
- Trial name
- NCT07246252
- Testing
- Process-Changed CMAB007, Xolair (omalizumab)
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy
PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects
This will be a randomized, double blind, two-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.
- Trial name
- NCT05564611
- Testing
- Omalizumab 150mg
- Where
- India
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Chronic Spontaneous Urticaria (CSU)
Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CSU) is an immune-mediated skin disorder characterized by pruritic wheals and/or angioedema. This study aims to evaluate the relationship between diet-derived antioxidant capacity and oxidative…
- Trial name
- NCT07431658
- Where
- Turkey (Türkiye)
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Istanbul Training and Research Hospital
Healthy Volunteers
Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair
A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous…
- Trial name
- NCT05053334
- Testing
- Omalizumab Prefilled Syringe
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Healthy
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy…
- Trial name
- NCT04018313
- Testing
- CT-P39, EU-approved Xolair, US-licensed Xolair
- Where
- 2 sites in Australia
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Celltrion
Food Allergy
Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)
Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and…
- Trial name
- NCT04037176
- Testing
- Omalizumab
- Where
- Denmark
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Carsten Bindslev-Jensen
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
Asthma Patients
ICS+LABA Vs. ICS+LABA+Omalizumab: Impact on Asthma Control and Gene Expression
Asthma is a chronic respiratory disease characterized by airway inflammation and obstruction, leading to wheezing, breathlessness, chest tightness, and coughing.
- Trial name
- NCT06869382
- Testing
- Foster BDP/Formoterol, Omalizimab
- Where
- Taiwan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Healthy
To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects
This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.
- Trial name
- NCT05413161
- Testing
- ADL-018, US-licensed XOLAIR, EU-Approved XOLAIR
- Where
- 2 sites in India
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Allergic Asthma
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and…
- Trial name
- NCT06494345
- Testing
- Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Xolair®, solution for subcutaneous administration, 150 mg
- Where
- Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
ALLERGIC ASTHMA
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe…
- Trial name
- NCT00283504
- Testing
- ANTI-IGE THERAPY (XOLAIR)
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of The King's Daughters
Asthma
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
- Trial name
- NCT04778137
- Testing
- Omalizumab
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
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
Similarity of Pharmacokinetics and Safety
Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.
- Trial name
- NCT04361812
- Testing
- HS632, Omalizumab (Xolair®)
- Where
- China
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
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