49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details


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

  
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1JPRN-jRCT2011210069
15/02/202205/02/2022A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus Systemic Lupus ErythematosusArm A: Afimetoran 30mg QD
Arm B: Afimetoran 10mg QD
Arm C: Afimetoran 2.5mg QD
Arm D: Placebo QD
Ranganathan UshaNULLRecruiting>= 18age old<= 70age oldBoth20Phase 2Argentina;Australia;Brazil;Chile;Colombia;France;Germany;Ireland;Mexico;Poland;Romania;Spain;Taiwan;USA;United Kingdom;Japan
2EUCTR2019-004021-25-IE
(EUCTR)
17/12/202108/10/2021A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Afimetoran (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: Afimetoran (10mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan
3EUCTR2019-004021-25-ES
(EUCTR)
14/12/202125/08/2021A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TLR7/8 Antagonist (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: TLR7/8 Antagonist (10mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan
4EUCTR2019-004021-25-PL
(EUCTR)
27/10/202124/09/2021A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Afimetoran (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: Afimetoran (10mg)
Product Code: BMS-986256
INN or Proposed INN: Afimetoran
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan
5EUCTR2019-004021-25-FR
(EUCTR)
13/10/202113/08/2021A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With ActiveSystemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus. Active Systemic Lupus Erythematosus.
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TLR7/8 Antagonist (2.5mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Product Name: TLR7/8 Antagonist (10mg)
Product Code: BMS-986256
INN or Proposed INN: Not available
Other descriptive name: BMS-986256-06, TLR7/8 Antagonist
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan
6NCT04895696
(ClinicalTrials.gov)
October 11, 202119/5/2021A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Afimetoran;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 Years70 YearsAll344Phase 2United States;Argentina;Australia;Brazil;Chile;China;Colombia;France;Germany;Ireland;Japan;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan;United Kingdom