QAX576 ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症1
85特発性間質性肺炎3
96クローン病3
98好酸球性消化管疾患1

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 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
1NCT00581997
(ClinicalTrials.gov)
December 200721/12/2007QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic SclerosisA Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System SclerosisPulmonary Fibrosis Secondary to Systemic SclerosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsBoth8Phase 2United States

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-020688-18-GB
(EUCTR)
29/06/201128/01/2011Safety and Efficacy of QAX576 in Patients With Progressive Idiopathic Pulmonary Fibrosis (IPF)A randomized, double-blind, placebo-controlled, multipledose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmacodynamics andpharmacokinetics of QAX576 in patients with rapidly progressive idiopathic pulmonary fibrosis Patients with rapidly progressive idiopathic pulmonary fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Code: QAX576Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
2NCT01266135
(ClinicalTrials.gov)
December 201017/12/2010Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPFIdiopathic Pulmonary FibrosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years80 YearsAll40Phase 2United States;United Kingdom
3NCT00532233
(ClinicalTrials.gov)
September 200719/9/2007SD, IL-13 Production Rate in IPFA Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: QAX576Novartis PharmaceuticalsNULLCompleted40 Years80 YearsAll52Phase 2United States

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01355614
(ClinicalTrials.gov)
June 201116/5/2011A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsA Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's DiseaseCrohn's DiseaseDrug: QAX576;Drug: InfliximabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll10Phase 2Germany;Switzerland
2EUCTR2010-019973-13-DE
(EUCTR)
14/01/201130/09/2010A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsA multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease Treatment of perianal fistulas in patients suffering from Crohn's Disease.
MedDRA version: 14.0;Level: PT;Classification code 10016717;Term: Fistula;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Code: QAX576
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
23Phase 2Germany;Switzerland
3NCT01316601
(ClinicalTrials.gov)
January 201114/3/2011A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's DiseaseCrohn's DiseaseDrug: QAX567Gerhard RoglerNovartis PharmaceuticalsCompleted18 YearsN/ABoth3Phase 2Switzerland

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
1NCT01022970
(ClinicalTrials.gov)
November 200925/11/2009Efficacy and Safety of QAX576 in Patients With Eosinophilic EsophagitisA Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisDrug: QAX576 placebo;Drug: QAX576Novartis PharmaceuticalsNULLCompleted18 Years50 YearsAll25Phase 2United States