Clinical trials: Omalizumab
Chronic Spontaneous Urticaria
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)
Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab…
- Trial name
- NCT04180488
- Testing
- Dupilumab SAR231893, non sedating H1-antihistamine
- Where
- 98 sites in United States, Argentina and 9 more
- Volunteers
- 397 people
- Sponsor
- Sanofi
Chronic Spontaneous Urticaria
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine…
- Trial name
- omalizumab (NCT04426890)
- Testing
- CT-P39, EU-approved Xolair
- Where
- Poland
- Volunteers
- 634 people
- Sponsor
- Celltrion
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
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age…
- Trial name
- NCT00500539
- Testing
- omalizumab
- Where
- 31 sites in United States, Argentina and 1 more
- Volunteers
- 155 people
- Sponsor
- Novartis
Allergic Asthma
Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.
- Trial name
- AA007 (NCT01976208)
- Testing
- Omalizumab
- Where
- 27 sites in China
- Volunteers
- 630 people
- Sponsor
- Shanghai Zhangjiang Biotechnology Limited Company
Asthma
A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe…
- Trial name
- NCT01922037
- Testing
- Omalizumab
- Where
- 145 sites in United States
- Volunteers
- 806 people
- Sponsor
- Hoffmann-La Roche
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
Asthma
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks.
- Trial name
- NCT00079937
- Testing
- Omalizumab, Fluticasone
- Where
- 56 sites in United States
- Volunteers
- 628 people
- Sponsor
- Novartis Pharmaceuticals
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
Chronic Spontaneous Urticaria (CSU), Allergic Asthma
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the…
- Trial name
- ROLL'YN-OMA (NCT07425639)
- Testing
- Omalizumab
- Where
- France
- Volunteers
- 225 people
- Sponsor
- Celltrion HealthCare France
Asthma
Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1.
- Trial name
- NCT00482508
- Testing
- Omalizumab
- Volunteers
- 95 people
- Sponsor
- Novartis
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
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.
Asthma
Cross-sectional Study for Identification and Description of Severe Asthma Patients
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered.
- Trial name
- NCT02293265
- Testing
- Short Acting Beta Agonist (SABA)
- Where
- 74 sites in United States, Australia and 4 more
- Volunteers
- 767 people
- Sponsor
- GlaxoSmithKline