Bms-986142 (DrugBank: BMS-986142)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 9 |
| 53 | シェーグレン症候群 | 3 |
| 160 | 先天性魚鱗癬 | 2 |
| 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 | EUCTR2015-002887-17-FR (EUCTR) | 19/06/2017 | 16/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | |||
| 2 | JPRN-JapicCTI-163317 | 28/7/2016 | 13/07/2016 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Intervention name : BMS-986142 INN of the intervention : - Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified | Bristol-Myers Squibb K.K. | NULL | complete | 18 | 120 | BOTH | 408 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Oceania |
| 3 | EUCTR2015-002887-17-BE (EUCTR) | 07/06/2016 | 16/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 4 | NCT02762123 (ClinicalTrials.gov) | May 2016 | 3/5/2016 | A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates | Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects | Rheumatoid Arthritis | Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | Both | 28 | Phase 1 | United States |
| 5 | EUCTR2015-002887-17-NL (EUCTR) | 20/04/2016 | 22/02/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 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 |
| 6 | EUCTR2015-002887-17-AT (EUCTR) | 29/03/2016 | 18/01/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986142 Product Code: BMS-986142 INN or Proposed INN: BMS986142 Product Name: BMS-986142 Product Code: BMS-986142 INN or Proposed INN: BMS986142 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 7 | EUCTR2015-002887-17-ES (EUCTR) | 28/03/2016 | 13/01/2016 | Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors | Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 2 | United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 8 | NCT02638948 (ClinicalTrials.gov) | February 16, 2016 | 21/12/2015 | Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis | Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors | Rheumatoid Arthritis | Drug: BMS-986142;Drug: Placebo;Drug: Methotrexate | Bristol-Myers Squibb | NULL | Completed | 18 Years | 120 Years | All | 508 | Phase 2 | United States;Argentina;Austria;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Belgium |
| 9 | NCT02456844 (ClinicalTrials.gov) | May 2015 | 27/5/2015 | Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients | Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects | Rheumatoid Arthritis | Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142;Drug: Methotrexate, Leucovorin and BMS-986142 | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | Both | 24 | Phase 1 | NULL |
| 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 | EUCTR2016-000101-37-GR (EUCTR) | 07/04/2017 | 15/03/2017 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study | subjects with moderate to severe Sjögren's syndrome MedDRA version: 19.1;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Poland;Belgium;Romania;Peru;Denmark;South Africa;Norway;Netherlands;United States;Greece;Russian Federation;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico | ||
| 2 | EUCTR2016-000101-37-IT (EUCTR) | 29/03/2017 | 27/02/2018 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study | subjects with moderate to severe Sjögren's syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: BTK Inhibitor Product Code: 1643368-58-4 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Greece;Russian Federation;Chile;Colombia;Italy;United Kingdom;France;Mexico;Poland;Belgium;Romania;Peru;Denmark;South Africa;Netherlands;Norway | ||
| 3 | NCT02843659 (ClinicalTrials.gov) | October 18, 2016 | 8/7/2016 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's Syndrome | Sjögren's Syndrome | Drug: BMS-931699;Drug: BMS-986142;Drug: Placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 70 Years | All | 45 | Phase 2 | United States;Australia;Chile;Colombia;Italy;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;France;Hungary |
| 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 | EUCTR2016-000101-37-GR (EUCTR) | 07/04/2017 | 15/03/2017 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study | subjects with moderate to severe Sjögren's syndrome MedDRA version: 19.1;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Poland;Belgium;Romania;Peru;Denmark;South Africa;Norway;Netherlands;United States;Greece;Russian Federation;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico | ||
| 2 | EUCTR2016-000101-37-IT (EUCTR) | 29/03/2017 | 27/02/2018 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study | subjects with moderate to severe Sjögren's syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: BTK Inhibitor Product Code: 1643368-58-4 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Greece;Russian Federation;Chile;Colombia;Italy;United Kingdom;France;Mexico;Poland;Belgium;Romania;Peru;Denmark;South Africa;Netherlands;Norway |