BMS-986165 ( DrugBank: - )


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14
96クローン病15
97潰瘍性大腸炎14

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
1NCT05620407
(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
2EUCTR2018-003471-35-ES
(EUCTR)
06/05/202010/05/2020Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Australia;Germany;Korea, Republic of
3EUCTR2018-003471-35-RO
(EUCTR)
31/12/201907/03/2022Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Israel;Russian Federation;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
4EUCTR2017-001203-79-ES
(EUCTR)
11/06/201930/04/2019A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
5EUCTR2018-003471-35-HU
(EUCTR)
29/05/201902/04/2019Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Japan;Korea, Republic of
6EUCTR2018-003471-35-PL
(EUCTR)
04/05/201903/04/2019Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus ErythematosusA Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Japan;Korea, Republic of
7NCT03920267
(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
8EUCTR2017-001203-79-DE
(EUCTR)
12/12/201827/02/2018A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
9NCT03541564
(ClinicalTrials.gov)
May 30, 201817/5/2018An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram EffectsA Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy SubjectsSystemic Lupus Erythematosus;Healthy ParticipantsDrug: BMS-986165;Drug: Moxifloxacin;Other: PlaceboBristol-Myers SquibbNULLCompleted18 Years50 YearsAll84Phase 1United States
10EUCTR2017-001203-79-PL
(EUCTR)
05/01/201803/11/2017A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
11EUCTR2017-001203-79-HU
(EUCTR)
04/12/201704/10/2017A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000017968;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Bristol-Myers Squibb international CorporationNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of
12NCT03252587
(ClinicalTrials.gov)
September 21, 201715/8/2017An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus ErythematosusA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: BMS-986165;Other: PlaceboBristol-Myers SquibbNULLActive, not recruiting18 Years75 YearsAll363Phase 2United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Bulgaria;France;Peru;Ukraine
13NCT03254784
(ClinicalTrials.gov)
September 13, 201717/8/2017A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet FormulationA Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy SubjectsSystemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel DiseasesDrug: BMS-986165 Capsule;Drug: BMS-986165 TabletBristol-Myers SquibbNULLCompleted18 Years50 YearsAll49Phase 1United States;Netherlands
14NCT03262727
(ClinicalTrials.gov)
September 1, 201724/8/2017The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsThe Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female SubjectsSystemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel DiseasesDrug: BMS-986165;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)Bristol-Myers SquibbNULLCompleted18 Years40 YearsFemale49Phase 1United 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
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
3EUCTR2017-001976-48-NL
(EUCTR)
17/03/202108/10/2020A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
4EUCTR2017-001976-48-BE
(EUCTR)
22/01/202126/01/2021A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS-986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan;United States;Portugal;Taiwan
5EUCTR2017-001976-48-FR
(EUCTR)
06/03/202009/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Portugal;Taiwan;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;China;Japan;Korea, Republic of
6EUCTR2017-001976-48-PT
(EUCTR)
16/12/201922/05/2019A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Portugal;Taiwan;Spain;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Romania;Germany;Japan
7EUCTR2017-001976-48-RO
(EUCTR)
30/08/201927/05/2022A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Croatia;Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Italy;France;Australia;Denmark;Netherlands
8EUCTR2017-001976-48-DK
(EUCTR)
15/04/201929/01/2019A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Bouvet Island;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
9EUCTR2017-001976-48-DE
(EUCTR)
20/12/201822/08/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Czechia;Taiwan;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
10EUCTR2017-001976-48-IT
(EUCTR)
20/12/201828/01/2021A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: [BMS-986165]
Other descriptive name: BMS986165
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Australia;Denmark;Germany;Korea, Republic of
11EUCTR2017-001976-48-ES
(EUCTR)
23/11/201817/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of
12EUCTR2017-001976-48-HU
(EUCTR)
13/09/201805/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Portugal;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Romania;Australia;Denmark;Germany;Korea, Republic of
13EUCTR2017-001976-48-PL
(EUCTR)
23/08/201817/07/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb international CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan
14EUCTR2017-001976-48-GB
(EUCTR)
23/08/201826/06/2018A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan
15NCT03599622
(ClinicalTrials.gov)
July 16, 201811/7/2018An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's DiseaseGranulomatous Colitis;Crohn's Disease;Crohn's Enteritis;Granulomatous EnteritisDrug: BMS-986165;Other: PlaceboBristol-Myers SquibbNULLActive, not recruiting18 Years75 YearsAll241Phase 2United States;Australia;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Taiwan;United Kingdom;Croatia;Hong Kong;Slovakia;Sweden;Ukraine

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
1EUCTR2019-004878-26-PL
(EUCTR)
18/01/202212/10/2021A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. Moderate to Severe Ulcerative Colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Poland;Australia;Netherlands;Germany;United Kingdom
2EUCTR2020-004461-40-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
3EUCTR2020-004461-40-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
4NCT04613518
(ClinicalTrials.gov)
March 15, 202128/10/2020A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative ColitisColitis, UlcerativeDrug: BMS-986165;Other: Placebo ComparatorBristol-Myers SquibbNULLActive, not recruiting18 Years65 YearsAll50Phase 2United States;Australia;Canada;Germany;Netherlands;Poland;Puerto Rico;United Kingdom
5EUCTR2019-004878-26-NL
(EUCTR)
10/02/202120/10/2020A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. Moderate to Severe Ulcerative Colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Australia;Germany;Netherlands;United Kingdom
6EUCTR2019-004878-26-DE
(EUCTR)
05/01/202124/08/2020A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants with Moderate to Severe Ulcerative ColitisA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis. Moderate to Severe Ulcerative Colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS-986165
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: TYK2 Inhibitor
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Australia;Netherlands;Germany;United Kingdom
7EUCTR2018-004694-27-FR
(EUCTR)
06/07/202010/04/2020Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Poland;Australia;Germany;Japan;Korea, Republic of;United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium
8EUCTR2018-004694-27-DE
(EUCTR)
24/09/201924/05/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
9EUCTR2018-004694-27-IT
(EUCTR)
21/08/201925/01/2021Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis - na Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: [BMS-986165]
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Czechia;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
10EUCTR2018-004694-27-CZ
(EUCTR)
13/08/201919/07/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
11EUCTR2018-004694-27-GB
(EUCTR)
23/07/201930/04/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
12NCT03934216
(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
13EUCTR2018-004694-27-PL
(EUCTR)
30/06/201915/05/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
14EUCTR2018-004694-27-HU
(EUCTR)
25/06/201906/05/2019Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with 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 Colitis Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Spain;Russian Federation;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Germany;Japan;Korea, Republic of