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: -

Clinical Trials

Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy

Phase 4

Completed

Conditions: Idiopathic Angioedema

Interventions: Drug: Placebos
Drug: Omalizumab

First Posted Date: 2016-11-17

Last Posted Date: 2022-11-01

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 12

Registration Number: NCT02966314

Locations: 🇺🇸
UW Madison, Madison, Wisconsin, United States

E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy

Phase 2

Conditions: Food Allergy

Interventions: Drug: Placebo
Drug: Chinese Herbal Medication
Drug: Omalizumab
Drug: Multi OIT

First Posted Date: 2016-08-25

Last Posted Date: 2020-08-12

Lead Sponsor: Xiu-Min Li

Target Recruit Count: 33

Registration Number: NCT02879006

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation

Phase 4

Withdrawn

Conditions: Urticaria

Interventions: Dietary Supplement: Vitamin D (400 IU/day)
Dietary Supplement: Vitamin D (4,000 IU/day)
Drug: Omalizumab

First Posted Date: 2016-04-19

Last Posted Date: 2018-05-01

Lead Sponsor: Selina Gierer, D.O.

Registration Number: NCT02742805

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

Sputum-derived Cellular Targets After Xolair (Omalizumab)

Phase 4

Terminated

Conditions: Asthma

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2016-01-20

Last Posted Date: 2019-09-30

Lead Sponsor: NYU Langone Health

Target Recruit Count: 3

Registration Number: NCT02658877

Locations: 🇺🇸
New York University School of Medicine, New York, New York, United States

Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Mepolizumab 100mg SC
Drug: Albuterol/salbutamol MDIs
Drug: Omalizumab

First Posted Date: 2016-01-13

Last Posted Date: 2019-08-19

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 145

Registration Number: NCT02654145

Locations: 🇸🇪
GSK Investigational Site, Stockholm, Sweden

Multi Immunotherapy to Test Tolerance and Xolair

Phase 2

Completed

Conditions: Food Allergy

Interventions: Drug: Omalizumab
Drug: Food Flour Buildup

First Posted Date: 2015-12-10

Last Posted Date: 2017-12-18

Lead Sponsor: Kari Christine Nadeau

Target Recruit Count: 70

Registration Number: NCT02626611

Locations: 🇺🇸
Sean N. Parker Center for Allergy Research at Stanford University, Mountain View, California, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
Northwest Asthma & Allergy Center, Seattle, Washington, United States

and more 4 locations

Preventing Asthma in High Risk Kids

Phase 2

Active, not recruiting

Conditions: Asthma

Interventions: Drug: Omalizumab
Drug: Placebo

First Posted Date: 2015-10-08

Last Posted Date: 2024-11-26

Lead Sponsor: Boston Children's Hospital

Target Recruit Count: 200

Registration Number: NCT02570984

Locations: 🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸
Indiana University/Riley Children's Hospital, Indianapolis, Indiana, United States
🇺🇸
Childrens Hospital Colorado, Aurora, Colorado, United States

and more 10 locations

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Phase 4

Completed

Conditions: CHRONIC SPONTANEOUS URTICARIA

Interventions: Drug: OMALIZUMAB

First Posted Date: 2015-09-15

Last Posted Date: 2020-02-25

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 136

Registration Number: NCT02550106

Locations: 🇫🇷
Novartis Investigative Site, Vandoeuvre Les Nancy, France

Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy

Phase 2

Conditions: Peanut Allergy

Interventions: Drug: Omalizumab

First Posted Date: 2015-03-30

Last Posted Date: 2018-08-24

Lead Sponsor: Caroline Nilsson

Target Recruit Count: 23

Registration Number: NCT02402231

Locations: 🇸🇪
Sachs´ Children´s Hospital, Södersjukhuset, Stockholm, Sweden

A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

Phase 4

Completed

Conditions: Urticaria

Interventions: Drug: Omalizumab
Drug: Placebo

First Posted Date: 2015-03-19

Last Posted Date: 2018-03-29

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 206

Registration Number: NCT02392624

Locations: 🇺🇸
Florida Ctr-Allergy & Asthma, Miami, Florida, United States
🇺🇸
James Q. Del Rosso, DO, LLC, Las Vegas, Nevada, United States
🇺🇸
Allergy & Asthma Research Center, San Antonio, Texas, United States

and more 37 locations

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