49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | EUCTR2017-005028-11-NL (EUCTR) | 23/09/2020 | 02/07/2020 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 2 | EUCTR2017-005028-11-HR (EUCTR) | 05/06/2020 | 23/11/2020 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 3 | EUCTR2017-005028-11-GR (EUCTR) | 20/05/2020 | 26/11/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 4 | EUCTR2017-005028-11-IT (EUCTR) | 19/12/2019 | 22/01/2021 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) - NA | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Other descriptive name: Baricitinib Trade Name: Olumiant Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Other descriptive name: Baricitinib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 5 | EUCTR2017-005028-11-GB (EUCTR) | 24/10/2019 | 18/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 6 | EUCTR2017-005026-37-HR (EUCTR) | 24/10/2019 | 20/01/2020 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 7 | NCT03843125 (ClinicalTrials.gov) | September 9, 2019 | 14/2/2019 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib | Eli Lilly and Company | Incyte Corporation | Active, not recruiting | 18 Years | N/A | All | 1100 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Chile;China;Colombia;Croatia;Czechia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;United Kingdom |
| 8 | EUCTR2017-005026-37-NL (EUCTR) | 06/08/2019 | 13/05/2019 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China | ||
| 9 | EUCTR2017-005026-37-GR (EUCTR) | 26/07/2019 | 03/05/2019 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China | ||
| 10 | EUCTR2017-005028-11-RO (EUCTR) | 22/07/2019 | 15/03/2022 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 11 | EUCTR2017-005028-11-PL (EUCTR) | 05/07/2019 | 23/04/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-TermSafety and Efficacy of Baricitinib in Patients with Systemic LupusErythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 12 | EUCTR2017-005028-11-AT (EUCTR) | 02/06/2019 | 28/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 13 | EUCTR2017-005028-11-ES (EUCTR) | 30/05/2019 | 31/05/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 14 | EUCTR2017-005028-11-HU (EUCTR) | 20/05/2019 | 02/04/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 15 | EUCTR2017-005028-11-DE (EUCTR) | 10/05/2019 | 28/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 16 | EUCTR2017-005028-11-CZ (EUCTR) | 08/04/2019 | 28/03/2019 | A study of Baricitinib in patients with Lupus | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 17 | EUCTR2017-005026-37-GB (EUCTR) | 27/03/2019 | 19/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 18 | EUCTR2017-005027-25-IT (EUCTR) | 20/12/2018 | 22/01/2021 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus - - | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant - EU/1/16/1170/009-016 Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricitinib Trade Name: Olumiant - EU/1/16/1170/001-008 Product Name: Baricitinib Product Code: [LY3009104] INN or Proposed INN: Baricinitib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Philippines;Spain;Chile;Colombia;Italy;India;France;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of | ||
| 19 | EUCTR2017-005026-37-AT (EUCTR) | 18/12/2018 | 25/09/2018 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Netherlands;Germany;China | ||
| 20 | EUCTR2017-005026-37-BE (EUCTR) | 17/12/2018 | 25/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 21 | EUCTR2017-005026-37-HU (EUCTR) | 19/11/2018 | 25/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 22 | EUCTR2017-005026-37-CZ (EUCTR) | 12/11/2018 | 26/10/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 825 | Phase 3 | United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China | ||
| 23 | EUCTR2017-005027-25-ES (EUCTR) | 21/09/2018 | 24/09/2018 | A study of Baricitinib in patients with Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France | ||
| 24 | NCT03616964 (ClinicalTrials.gov) | August 2, 2018 | 1/8/2018 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Completed | 18 Years | N/A | All | 777 | Phase 3 | United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain |
| 25 | NCT03616912 (ClinicalTrials.gov) | August 2, 2018 | 1/8/2018 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Active, not recruiting | 18 Years | N/A | All | 809 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine |
| 26 | EUCTR2015-004404-35-ES (EUCTR) | 29/04/2016 | 04/04/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Lilly S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of | ||
| 27 | EUCTR2015-004404-35-PL (EUCTR) | 12/04/2016 | 31/03/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of | ||
| 28 | EUCTR2015-004404-35-FR (EUCTR) | 12/04/2016 | 04/05/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of | ||
| 29 | EUCTR2015-004404-35-AT (EUCTR) | 06/04/2016 | 24/03/2016 | A study in Lupus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) | Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of | ||
| 30 | NCT02708095 (ClinicalTrials.gov) | March 24, 2016 | 10/3/2016 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 314 | Phase 2 | United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan |
| 31 | JPRN-JapicCTI-163359 | 01/3/2016 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | Systemic Lupus Erythematosus (SLE) | Intervention name : Baricitinib INN of the intervention : Baricitinib Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks Control intervention name : Placebo Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks | Eli Lilly Japan K.K. | NULL | 18 | BOTH | Phase 2 | NULL | ||||
| 32 | JPRN-JapicCTI-184095 | 03/09/2018 | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) | Systemic Lupus Erythematosus | Intervention name : LY3009104 INN of the intervention : Baricitinib Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally. | Eli Lilly Japan K.K. | NULL | recruiting | 18 | BOTH | Phase 3 | NULL |