Omalizumab

Generic Name
Omalizumab
Brand Names
Xolair, Omlyclo
Drug Type
Biotech
Chemical Formula
-
CAS Number
242138-07-4
Unique Ingredient Identifier
2P471X1Z11
Background

Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefil...

Indication

This drug is an anti-IgE antibody indicated for:

Associated Conditions
Chronic Idiopathic Urticaria, Moderate Asthma, Severe Asthma
Associated Therapies
-

Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-11-03
Last Posted Date
2012-07-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
79
Registration Number
NCT01007149
Locations
🇫🇷

Novartis Investigative Site, Toulouse, France

The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-10-28
Last Posted Date
2014-04-07
Lead Sponsor
Johns Hopkins University
Target Recruit Count
19
Registration Number
NCT01003301
Locations
🇺🇸

Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, United States

Xolair Treatment for Milk Allergic Children

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-08-28
Last Posted Date
2018-10-02
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
10
Registration Number
NCT00968110
Locations
🇺🇸

Children's Hosptial Boston, Boston, Massachusetts, United States

🇺🇸

Stanford Uneiversity Medical Center, Stanford, California, United States

Omalizumab in the Treatment of Peanut Allergy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-07-30
Last Posted Date
2017-07-12
Lead Sponsor
Johns Hopkins University
Target Recruit Count
51
Registration Number
NCT00949078
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy

First Posted Date
2009-07-03
Last Posted Date
2018-03-01
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
13
Registration Number
NCT00932282
Locations
🇺🇸

University of North Carolina, Chapel Hill, North Carolina, United States

Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-03-27
Last Posted Date
2011-11-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
271
Registration Number
NCT00870584
Locations
🇺🇸

Palm Spring Research Institute, Inc, Hialeah, Florida, United States

🇺🇸

Paul A Shapero, MD, Bangor, Maine, United States

🇺🇸

Pediatric Pulmonary Associates of North Texas, PA, Dallas, Texas, United States

and more 47 locations

Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-01-14
Last Posted Date
2009-01-14
Lead Sponsor
Medical University of Vienna
Registration Number
NCT00822783
Locations
🇦🇹

Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria., Vienna, Waehringer Guertel 18-20, Austria

An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

First Posted Date
2008-11-10
Last Posted Date
2011-09-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
14
Registration Number
NCT00787917
Locations
🇬🇧

Novartis Investigator Site, London, United Kingdom

The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-04-14
Last Posted Date
2013-10-01
Lead Sponsor
Creighton University
Target Recruit Count
49
Registration Number
NCT00657891
Locations
🇺🇸

Creighton University Medical Center, Omaha, Nebraska, United States

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