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 | NCT05620407 (ClinicalTrials.gov) | January 12, 2023 | 10/11/2022 | A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus | 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-2) | Systemic Lupus Erythematosus | Drug: Deucravacitinib;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 490 | Phase 3 | United States;Argentina;Australia;Brazil;Chile;Czechia;Greece;Hungary;Japan;Mexico;Peru;Poland;Portugal;Singapore;Spain;Taiwan;United Kingdom |
| 2 | EUCTR2018-003471-35-ES (EUCTR) | 06/05/2020 | 10/05/2020 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Australia;Germany;Korea, Republic of | ||
| 3 | EUCTR2018-003471-35-RO (EUCTR) | 31/12/2019 | 07/03/2022 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of | ||
| 4 | EUCTR2017-001203-79-ES (EUCTR) | 11/06/2019 | 30/04/2019 | A 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 Corporation | NULL | Authorised-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): no | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 5 | EUCTR2018-003471-35-HU (EUCTR) | 29/05/2019 | 02/04/2019 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Japan;Korea, Republic of | ||
| 6 | EUCTR2018-003471-35-PL (EUCTR) | 04/05/2019 | 03/04/2019 | Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus | A 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Japan;Korea, Republic of | ||
| 7 | NCT03920267 (ClinicalTrials.gov) | March 26, 2019 | 27/3/2019 | Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986165 | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 75 Years | All | 261 | Phase 2 | United States;Argentina;Brazil;Canada;Colombia;Hungary;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Australia;Germany;Israel |
| 8 | EUCTR2017-001203-79-DE (EUCTR) | 12/12/2018 | 27/02/2018 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 9 | NCT03541564 (ClinicalTrials.gov) | May 30, 2018 | 17/5/2018 | An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects | A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects | Systemic Lupus Erythematosus;Healthy Participants | Drug: BMS-986165;Drug: Moxifloxacin;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 84 | Phase 1 | United States |
| 10 | EUCTR2017-001203-79-PL (EUCTR) | 05/01/2018 | 03/11/2017 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of | ||
| 11 | EUCTR2017-001203-79-HU (EUCTR) | 04/12/2017 | 04/10/2017 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 12 | NCT03252587 (ClinicalTrials.gov) | September 21, 2017 | 15/8/2017 | An Investigational Study to Evaluate BMS-986165 in Participants 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 | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | 75 Years | All | 363 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;Colombia;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Spain;Taiwan;Bulgaria;France;Peru;Ukraine |
| 13 | NCT03254784 (ClinicalTrials.gov) | September 13, 2017 | 17/8/2017 | A 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 Formulation | A 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 Subjects | Systemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel Diseases | Drug: BMS-986165 Capsule;Drug: BMS-986165 Tablet | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 49 | Phase 1 | United States;Netherlands |
| 14 | NCT03262727 (ClinicalTrials.gov) | September 1, 2017 | 24/8/2017 | The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients | The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects | Systemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel Diseases | Drug: BMS-986165;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol) | Bristol-Myers Squibb | NULL | Completed | 18 Years | 40 Years | Female | 49 | Phase 1 | United States |