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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2011210069 | 15/02/2022 | 05/02/2022 | A 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 Erythematosus | Arm A: Afimetoran 30mg QD Arm B: Afimetoran 10mg QD Arm C: Afimetoran 2.5mg QD Arm D: Placebo QD | Ranganathan Usha | NULL | Recruiting | >= 18age old | <= 70age old | Both | 20 | Phase 2 | Argentina;Australia;Brazil;Chile;Colombia;France;Germany;Ireland;Mexico;Poland;Romania;Spain;Taiwan;USA;United Kingdom;Japan |
| 2 | EUCTR2019-004021-25-IE (EUCTR) | 17/12/2021 | 08/10/2021 | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 3 | EUCTR2019-004021-25-ES (EUCTR) | 14/12/2021 | 25/08/2021 | 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. | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 4 | EUCTR2019-004021-25-PL (EUCTR) | 27/10/2021 | 24/09/2021 | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan | ||
| 5 | EUCTR2019-004021-25-FR (EUCTR) | 13/10/2021 | 13/08/2021 | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2 | United States;Taiwan;Spain;Ireland;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Poland;Romania;Australia;Germany;Japan | ||
| 6 | NCT04895696 (ClinicalTrials.gov) | October 11, 2021 | 19/5/2021 | A 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 Erythematosus | Drug: Afimetoran;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 70 Years | All | 344 | Phase 2 | United States;Argentina;Australia;Brazil;Chile;China;Colombia;France;Germany;Ireland;Japan;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan;United Kingdom |