Deucravacitinib ( DrugBank: Deucravacitinib )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス3
96クローン病3
97潰瘍性大腸炎4

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05617677
(ClinicalTrials.gov)
January 12, 20238/11/2022A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)Systemic Lupus ErythematosusDrug: Deucravacitinib;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years75 YearsAll490Phase 3United States;Argentina;Brazil;Bulgaria;Canada;China;Colombia;France;Germany;Hong Kong;Ireland;Italy;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Portugal;Romania
2NCT05620407
(ClinicalTrials.gov)
January 12, 202310/11/2022A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus ErythematosusA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)Systemic Lupus ErythematosusDrug: Deucravacitinib;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years75 YearsAll490Phase 3United States;Argentina;Australia;Brazil;Chile;Czechia;Greece;Hungary;Japan;Mexico;Peru;Poland;Portugal;Singapore;Spain;Taiwan;United Kingdom
3NCT03920267
(ClinicalTrials.gov)
March 26, 201927/3/2019Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BMS-986165Bristol-Myers SquibbNULLActive, not recruiting18 Years75 YearsAll261Phase 2United States;Argentina;Brazil;Canada;Colombia;Hungary;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Australia;Germany;Israel

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
1EUCTR2020-004461-40-IT
(EUCTR)
15/09/202118/10/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: [BMS-986165]
INN or Proposed INN: deucravacitinib
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
2EUCTR2020-004461-40-DE
(EUCTR)
04/08/202112/05/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: BMS-986165
INN or Proposed INN: deucravacitinib
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
3NCT04877990
(ClinicalTrials.gov)
May 7, 20214/5/2021A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative ColitisCrohn Disease;Ulcerative ColitisDrug: DeucravacitinibBristol-Myers SquibbNULLRecruiting18 YearsN/AAll300Phase 2United States;Australia;Brazil;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;United Kingdom

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
1EUCTR2020-004461-40-IT
(EUCTR)
15/09/202118/10/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: [BMS-986165]
INN or Proposed INN: deucravacitinib
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
2EUCTR2020-004461-40-DE
(EUCTR)
04/08/202112/05/2021Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: deucravacitinib
Product Code: BMS-986165
INN or Proposed INN: deucravacitinib
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
3NCT04877990
(ClinicalTrials.gov)
May 7, 20214/5/2021A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative ColitisAn Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative ColitisCrohn Disease;Ulcerative ColitisDrug: DeucravacitinibBristol-Myers SquibbNULLRecruiting18 YearsN/AAll300Phase 2United States;Australia;Brazil;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;United Kingdom
4NCT03934216
(ClinicalTrials.gov)
July 1, 201930/4/2019Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: BMS-986165;Other: PlaceboBristol-Myers SquibbNULLActive, not recruiting18 Years80 YearsAll131Phase 2United States;Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom;Canada