GSK2831781 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎8

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
1EUCTR2018-003278-28-BG
(EUCTR)
22/04/202023/05/2019Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
2EUCTR2018-003278-28-NL
(EUCTR)
13/12/201922/07/2019Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of
3EUCTR2018-003278-28-HU
(EUCTR)
24/10/201925/03/2019Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
4EUCTR2018-003278-28-CZ
(EUCTR)
25/09/201915/04/2019Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2Serbia;United States;Czechia;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
5EUCTR2018-003278-28-PL
(EUCTR)
03/08/201911/06/2019Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
320Phase 2United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
6EUCTR2018-003278-28-FR
(EUCTR)
07/05/201909/05/2019Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
7NCT03893565
(ClinicalTrials.gov)
May 6, 201926/3/2019Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative ColitisA Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: GSK2831781 - Double Blind Phase;Drug: Placebo;Drug: GSK2831781 - Open Label phaseGlaxoSmithKlineNULLTerminated18 YearsN/AAll104Phase 2United States;Bulgaria;Czechia;Estonia;France;India;Japan;Netherlands;Poland;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;United Kingdom;Belgium;Canada;Hungary;Korea, Republic of
8EUCTR2018-003278-28-GB
(EUCTR)
29/04/201914/12/2018Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781
GlaxoSmithKline Research & Development LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of