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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR OMALIZUMAB


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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...
NCT00086606 ↗ A Safety and Efficacy Study of Xolair in Peanut Allergy Terminated Genentech, Inc. Phase 2 2004-06-01 This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.
NCT00096954 ↗ A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT) Completed Genentech, Inc. Phase 4 2006-02-01 This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).
NCT00109187 ↗ An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g Completed Genentech, Inc. Phase 3 2002-06-01 This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.
NCT00109200 ↗ A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma Completed Genentech, Inc. Phase 3 2003-05-01 This is a continued access protocol to provide subjects who have completed Genentech, Inc. Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1 with continued Xolair treatment. Subject eligibility will be based on disease severity and asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose was <9 months prior to screening visit will continue with the same Xolair dosing regimen that they received in the previous Genentech or Novartis clinical study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for omalizumab

Condition Name

Condition Name for omalizumab
Intervention Trials
Asthma 47
Allergic Asthma 11
Chronic Spontaneous Urticaria 9
Food Allergy 9
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Condition MeSH

Condition MeSH for omalizumab
Intervention Trials
Asthma 63
Urticaria 28
Chronic Urticaria 22
Hypersensitivity 15
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Clinical Trial Locations for omalizumab

Trials by Country

Trials by Country for omalizumab
Location Trials
United States 458
Canada 41
Germany 38
China 35
Japan 29
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Trials by US State

Trials by US State for omalizumab
Location Trials
California 32
Maryland 29
New York 24
Colorado 19
Ohio 19
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Clinical Trial Progress for omalizumab

Clinical Trial Phase

Clinical Trial Phase for omalizumab
Clinical Trial Phase Trials
Phase 4 51
Phase 3 34
Phase 2/Phase 3 7
[disabled in preview] 67
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Clinical Trial Status

Clinical Trial Status for omalizumab
Clinical Trial Phase Trials
Completed 104
Recruiting 15
Not yet recruiting 13
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Clinical Trial Sponsors for omalizumab

Sponsor Name

Sponsor Name for omalizumab
Sponsor Trials
Genentech, Inc. 39
Novartis Pharmaceuticals 32
Novartis 21
[disabled in preview] 33
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Sponsor Type

Sponsor Type for omalizumab
Sponsor Trials
Other 144
Industry 126
NIH 18
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