Flexible Subscriptions to Match your Budget and Timeline See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Medtronic
Baxter
Merck
Boehringer Ingelheim

Last Updated: December 1, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR OMALIZUMAB

➤ Subscribe for complete access

« Back to Dashboard

Biosimilar Clinical Trials for omalizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT05053334 ↗ Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair Not yet recruiting CuraTeQ Biologics Private Ltd. Phase 1 2021-11-01 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 injection in healthy male volunteers.
NCT05053334 ↗ Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair Not yet recruiting Syneos Health Phase 1 2021-11-01 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 injection in healthy male volunteers.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for omalizumab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00046748 ↗ Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma Completed Novartis Pharmaceuticals Phase 3 2001-12-01 The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.
NCT00079937 ↗ Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma Completed Novartis Pharmaceuticals Phase 3 2004-04-01 A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
NCT00084097 ↗ Omalizumab to Treat Eosinophilic Gastroenteritis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2004-06-02 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). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma. Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants undergo the following procedures: - Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. - Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed. - Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into t...
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for omalizumab

Condition Name

Condition Name for omalizumab
Intervention Trials
Asthma 46
Allergic Asthma 11
Chronic Spontaneous Urticaria 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for omalizumab
Intervention Trials
Asthma 62
Urticaria 27
Chronic Urticaria 21
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for omalizumab

Trials by Country

Trials by Country for omalizumab
Location Trials
United States 457
Canada 41
Germany 38
China 33
Japan 29
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for omalizumab
Location Trials
California 32
Maryland 29
New York 24
Ohio 19
Colorado 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for omalizumab

Clinical Trial Phase

Clinical Trial Phase for omalizumab
Clinical Trial Phase Trials
Phase 4 50
Phase 3 32
Phase 2/Phase 3 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for omalizumab
Clinical Trial Phase Trials
Completed 104
Recruiting 12
Unknown status 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for omalizumab

Sponsor Name

Sponsor Name for omalizumab
Sponsor Trials
Genentech, Inc. 39
Novartis Pharmaceuticals 32
Novartis 21
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for omalizumab
Sponsor Trials
Other 138
Industry 123
NIH 17
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Mallinckrodt
Johnson and Johnson
Merck
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.