Omalizumab ( DrugBank: Omalizumab )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ1
53シェーグレン症候群1
65原発性免疫不全症候群1
98好酸球性消化管疾患3
162類天疱瘡(後天性表皮水疱症を含む。)2
226間質性膀胱炎(ハンナ型)1
299嚢胞性線維症7

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-017306-36-NL
(EUCTR)
19/11/201019/08/2010ANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RA. - TIGERANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RA. - TIGER RHEUMATOID ARTHRITIS
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid
Trade Name: Xolair
Product Name: OMALIZUMAB
INN or Proposed INN: OMALIZUMAB
Other descriptive name: Xolair
Leiden University Medical Center, Department of RheumatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01716312
(ClinicalTrials.gov)
January 8, 201423/10/2012Omalizumab for LupusA Phase 1b, Randomized, Double-Blind, Placebo Controlled Study With an Open Label Extension to Evaluate the Safety and Tolerability of Omalizumab, A Humanized IgG1 Monoclonal Antibody in Patients With Lupus (STOP LUPUS)Systemic Lupus Erthematosus;Sjogren's SyndromeDrug: OmalizumabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years100 YearsAll17Phase 1United States

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00260702
(ClinicalTrials.gov)
November 24, 20051/12/2005Omalizumab to Treat Hyper-IgE (Job's) SyndromePilot Study of Omalizumab (Xolair) in Hyper IgE (Job's) SyndromeHyper-IgE Syndrome;Job's SyndromeDrug: Omalizumab (Xolair)National Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted6 Years76 YearsAll1Phase 1United States

98. 好酸球性消化管疾患


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01040598
(ClinicalTrials.gov)
June 200927/12/2009Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease ModelIdentifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease ModelEosinophilic EsophagitisBiological: OmalizumabO & O Alpan LLCGenentech, Inc.Completed12 Years76 YearsBoth19Phase 1United States
2NCT00123630
(ClinicalTrials.gov)
November 200521/7/2005A Pilot Study of the Treatment of Eosinophilic Esophagitis With OmalizumabA Pilot Study of the Treatment of Eosinophilic Esophagitis With OmalizumabEsophagitisDrug: omalizumab;Drug: PlaceboUniversity of UtahNovartis PharmaceuticalsCompleted12 Years60 YearsAll30Phase 2United States
3NCT00084097
(ClinicalTrials.gov)
June 2, 20045/6/2004Omalizumab to Treat Eosinophilic GastroenteritisPilot Study of Omalizumab in Eosinophilic GastroenteritisGastroenteritisDrug: OmalizumabNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted12 Years76 YearsAll30Phase 2United States

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04128176
(ClinicalTrials.gov)
May 25, 202312/10/2019Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous PemphigoidAn Open-Label Study to Evaluate the Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous PemphigoidBullous PemphigoidDrug: Rituximab combined with OmalizumabUniversity of California, DavisNULLNot yet recruiting18 Years90 YearsAll15Phase 3United States
2NCT00472030
(ClinicalTrials.gov)
August 20078/5/2007Efficacy and Safety of Omalizumab in Bullous PemphigoidAn Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous PemphigoidBullous PemphigoidDrug: Omalizumab;Drug: prednisoneUniversity of IowaGenentech, Inc.Completed18 YearsN/AAll2Phase 4United States

226. 間質性膀胱炎(ハンナ型)


臨床試験数 : 145 薬物数 : 156 - (DrugBank : 51) / 標的遺伝子数 : 64 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01294878
(ClinicalTrials.gov)
March 200911/2/2011Omalizumab in Interstitial Cystitis/Bladder Pain SyndromeExplorative Study on the Use of Omalizumab in Patients Suffering From Interstitial Cystitis/Painful Bladder SyndromeInterstitial Cystitis;Painful Bladder SyndromeDrug: omalizumabIRCCS Policlinico S. MatteoNULLCompleted18 YearsN/AFemale3Phase 3Italy

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-006648-23-IE
(EUCTR)
11/12/200915/04/2009An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: XolairNovartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
2EUCTR2007-006648-23-IT
(EUCTR)
06/08/200922/05/2009An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - NDAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: XOLAIR
INN or Proposed INN: Omalizumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
3EUCTR2007-006648-23-NL
(EUCTR)
08/06/200903/09/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair
INN or Proposed INN: omalizumab
Other descriptive name: Recombinant humanized monoclonal antibody omalizumab to IgE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
4EUCTR2007-006648-23-GB
(EUCTR)
27/02/200909/10/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair
INN or Proposed INN: Omalizumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Germany;United Kingdom;Netherlands;Belgium;Ireland;Italy
5EUCTR2007-006648-23-DE
(EUCTR)
12/11/200815/08/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung
Product Name: Xolair
Product Code: IGE025
INN or Proposed INN: Omalizumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
6NCT00787917
(ClinicalTrials.gov)
November 20087/11/2008An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)Cystic Fibrosis;Allergic Bronchopulmonary AspergillosisDrug: Omalizumab;Drug: Placebo;Drug: ItraconazoleNovartis PharmaceuticalsNULLTerminated12 YearsN/AAll14Phase 4Belgium;Germany;Italy;Netherlands;United Kingdom
7EUCTR2007-006648-23-BE
(EUCTR)
30/09/200828/08/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair
INN or Proposed INN: omalizumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy