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

Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

Phase 3

Completed

Conditions: Allergic Asthma

Interventions: Drug: Omalizumab

First Posted Date: 2011-04-05

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 38

Registration Number: NCT01328886

Locations: 🇯🇵
Novartis Investigative Site, Gifu, Japan

Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome

Phase 3

Completed

Conditions: Interstitial Cystitis
Painful Bladder Syndrome

Interventions: Drug: omalizumab

First Posted Date: 2011-02-14

Last Posted Date: 2011-02-14

Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Target Recruit Count: 3

Registration Number: NCT01294878

Locations: 🇮🇹
Divisione Urologia IRCCS Policlinico San Matteo, Pavia, Italy

A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Phase 3

Completed

Conditions: Chronic Idiopathic Urticaria

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2011-02-09

Last Posted Date: 2013-10-11

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 323

Registration Number: NCT01292473

Xolair Enhances Oral Desensitization in Peanut Allergic Patients

Phase 1

Completed

Conditions: Peanut Allergy

Interventions: Drug: Omalizumab

First Posted Date: 2011-02-07

Last Posted Date: 2015-04-07

Lead Sponsor: Lynda Schneider

Target Recruit Count: 13

Registration Number: NCT01290913

Locations: 🇺🇸
Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts, United States

A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Phase 3

Completed

Conditions: Chronic Idiopathic Urticaria

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2011-02-01

Last Posted Date: 2013-11-27

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 319

Registration Number: NCT01287117

A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

Phase 3

Completed

Conditions: Chronic Idiopathic Urticaria

Interventions: Drug: Placebo
Drug: Omalizumab
Drug: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Drug: Diphenhydramine

First Posted Date: 2010-12-22

Last Posted Date: 2013-11-26

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 336

Registration Number: NCT01264939

Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy

Phase 3

Completed

Conditions: Persistent Allergic Asthma

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2010-09-16

Last Posted Date: 2015-03-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 616

Registration Number: NCT01202903

Locations: 🇨🇳
Novartis Investigative Site, Shanghai, China

Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)

Phase 3

Completed

Conditions: Allergic Asthma

Interventions: Drug: omalizumab

First Posted Date: 2010-07-02

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 51

Registration Number: NCT01155700

Locations: 🇯🇵
Novartis Investigative Site, Osaka, Japan

A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

Phase 4

Completed

Conditions: Allergic Asthma

Interventions: Drug: Placebo
Drug: Omalizumab
Drug: Asthma therapies

First Posted Date: 2010-05-18

Last Posted Date: 2014-10-15

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 176

Registration Number: NCT01125748

Omalizumab in Non-atopic Asthma

Phase 2

Conditions: Bronchial Asthma

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2010-04-29

Last Posted Date: 2011-01-21

Lead Sponsor: King's College London

Target Recruit Count: 40

Registration Number: NCT01113437

Locations: 🇬🇧
Guy's Hospital, London, UK, London, United Kingdom
🇬🇧
London Chest Hospital, London, United Kingdom

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