BMS-936557 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病4
97潰瘍性大腸炎7

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
1EUCTR2011-002981-19-PL
(EUCTR)
21/03/201212/01/2012Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease.Revised Protocol 043 incorporating Protocol Amendment 05Pharmacogenetics Blood Sample Amendment 01 CROHN’S DISEASE
MedDRA version: 16.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.1;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;France;Hungary;Belgium;Poland;South Africa
2EUCTR2011-002981-19-HU
(EUCTR)
06/03/201227/12/2011Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 CROHN’S DISEASE
MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2France;United States;Hungary;Belgium;Poland;South Africa
3EUCTR2011-002981-19-BE
(EUCTR)
14/02/201214/12/2011Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 CROHN’S DISEASE
MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856
MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2France;United States;Hungary;Poland;Belgium;South Africa
4NCT01466374
(ClinicalTrials.gov)
December 20113/11/2011Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's DiseaseA Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: BMS-936557 (Anti-IP-10 Antibody)Bristol-Myers SquibbNULLCompleted18 YearsN/ABoth121Phase 2United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa

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
1EUCTR2010-022506-41-PL
(EUCTR)
24/10/201105/09/2011Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 Colitis, Ulcerative
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
386Phase 2United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany
2EUCTR2010-022506-41-BE
(EUCTR)
23/08/201117/06/2011Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05 Colitis, Ulcerative
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: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
386Phase 2United States;Austria;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Australia;South Africa;Netherlands;Germany
3EUCTR2010-022506-41-DE
(EUCTR)
18/07/201128/02/2011Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis Colitis, Ulcerative
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
386Phase 2United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Germany;Netherlands
4EUCTR2010-022506-41-HU
(EUCTR)
31/05/201113/04/2011Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05 Colitis, Ulcerative
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
386Phase 2United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany
5EUCTR2010-022506-41-IT
(EUCTR)
16/05/201128/12/2011A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC) - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis Colitis, Ulcerative
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
386Phase 2United States;Hungary;Mexico;Canada;Poland;Brazil;Austria;Australia;South Africa;Germany;Italy
6EUCTR2010-022506-41-AT
(EUCTR)
05/05/201101/03/2011Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis Colitis, Ulcerative
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
386Phase 2United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Netherlands;Germany
7NCT01294410
(ClinicalTrials.gov)
March 201110/2/2011Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative ColitisA Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)Colitis, UlcerativeDrug: Placebo;Drug: Anti-IP-10 AntibodyBristol-Myers SquibbNULLCompleted18 YearsN/ABoth305Phase 2United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Mexico;Netherlands;Poland;South Africa