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
-

Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-03-17
Last Posted Date
2018-07-09
Lead Sponsor
University of Virginia
Target Recruit Count
31
Registration Number
NCT02388997
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-10-17
Last Posted Date
2019-05-30
Lead Sponsor
Yale University
Target Recruit Count
9
Registration Number
NCT02266355
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

Omalizumab in Severe and Refractory Solar Urticaria

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-10-10
Last Posted Date
2018-10-12
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
10
Registration Number
NCT02262130
Locations
🇫🇷

CHRU de Lille, Lille, France

🇫🇷

Dermatology department, Hôpital Saint-Louis, Paris, France

🇫🇷

CHU de Grenoble, Grenoble, France

and more 10 locations

Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

Not Applicable
Conditions
Interventions
First Posted Date
2014-07-15
Last Posted Date
2014-07-15
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
20
Registration Number
NCT02191072
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Urticaria Facticia Treatment With Omalizumab (UFO)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-06-20
Last Posted Date
2020-11-03
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
61
Registration Number
NCT02169115
Locations
🇩🇪

University Dermatology Freiburg, Freiburg, Germany

🇩🇪

Dermatology University Mainz, Mainz, Germany

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-06-11
Last Posted Date
2018-09-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
314
Registration Number
NCT02161562
Locations
🇵🇦

Novartis Investigative Site, Panama, Panama

Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-21
Last Posted Date
2018-02-22
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
5
Registration Number
NCT02118987
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-12-30
Last Posted Date
2017-12-11
Lead Sponsor
Johns Hopkins University
Target Recruit Count
17
Registration Number
NCT02023151
Locations
🇺🇸

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

Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-11-05
Last Posted Date
2015-12-22
Lead Sponsor
Shanghai Zhangjiang Biotechnology Limited Company
Target Recruit Count
630
Registration Number
NCT01976208
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

🇨🇳

Chinese PLA Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China

🇨🇳

The Second Affiliated Hospital of Zhejiang University, Hangzhou, China

and more 24 locations

A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-08-14
Last Posted Date
2017-12-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
806
Registration Number
NCT01922037
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

🇺🇸

Chest Medicine Consultants, Chicago, Illinois, United States

and more 140 locations
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