Tralokinumab ( DrugBank: Tralokinumab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎3
97潰瘍性大腸炎6

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
1NCT02036580
(ClinicalTrials.gov)
January 201413/1/2014D2212C00002 J-Phase II StudyA Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: tralokinumab cohort 1;Biological: tralokinumab cohort 2;Other: PlaceboAstraZenecaMedImmune LLCCompleted50 YearsN/AAll37Phase 2Japan
2NCT01629667
(ClinicalTrials.gov)
October 201212/6/2012A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary FibrosisA Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisBiological: Tralokinumab;Other: PlaceboMedImmune LLCNULLTerminated50 Years79 YearsAll409Phase 2United States;Australia;Canada;Israel;Korea, Republic of;Peru
3JPRN-JapicCTI-142452
21/02/2014A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary FibrosisA Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary FibrosisIntervention name : Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
Dosage And administration of the intervention : Low Dose, Biological: tralokinumab cohort 1, High Dose, Biological: tralokinumab cohort 2
AstraZenecaMedImmune LLC50BOTHPhase 2NULL

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004812-40-GB
(EUCTR)
12/04/201221/03/2012Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110Phase 2Czech Republic;Netherlands;Germany;Italy;United Kingdom
2NCT01482884
(ClinicalTrials.gov)
March 201229/11/2011Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative ColitisA Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative ColitisUlcerative ColitisDrug: tralokinumab;Drug: placeboAstraZenecaMedImmune LtdCompleted18 Years65 YearsAll147Phase 2Czech Republic;France;Germany;Italy;Poland;United Kingdom;Netherlands
3EUCTR2011-004812-40-DE
(EUCTR)
26/01/201225/11/2011Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110Phase 2Czech Republic;Netherlands;Germany;United Kingdom;Italy
4EUCTR2011-004812-40-NL
(EUCTR)
25/01/201222/12/2011Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis Ulcerative Colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110Phase 2Czech Republic;Netherlands;United Kingdom;Italy
5EUCTR2011-004812-40-CZ
(EUCTR)
24/01/201229/12/2011Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110Phase 2Czech Republic;Netherlands;United Kingdom;Italy
6EUCTR2011-004812-40-IT
(EUCTR)
12/12/201102/03/2012A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitisA phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
Other descriptive name: NA
ASTRAZENECANULLNot RecruitingFemale: yes
Male: yes
110Phase 2Czech Republic;Netherlands;Germany;United Kingdom;Italy