Ly3074828 (DrugBank: -)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 37 | 膿疱性乾癬（汎発型） | 1 |
| 96 | クローン病 | 18 |
| 97 | 潰瘍性大腸炎 | 33 |
| 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-JapicCTI-184065 | 22/8/2018 | 15/08/2018 | I6T-MC-AMAJ | A Multicenter Randomized Double-Blind Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-2 | Psoriasis valgaris, Generalized pustular psoriasis, Erythrodermic psoriasis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Administered subcutaneous injection Control intervention name : Secukinumab INN of the control intervention : secukinumab Dosage And administration of the control intervention : Administered subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Administered subcutaneous injection | Eli Lilly Japan K.K. | NULL | complete | 20 | BOTH | 120 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania |
| 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 | EUCTR2018-004614-18-DK (EUCTR) | 08/09/2020 | 05/08/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 2 | EUCTR2018-004614-18-HR (EUCTR) | 24/08/2020 | 23/11/2020 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 3 | NCT04232553 (ClinicalTrials.gov) | June 22, 2020 | 15/1/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease | Crohn's Disease | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 18 Years | N/A | All | 778 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Romania;Russian Federation;Spain;Turkey;Ukraine |
| 4 | EUCTR2019-002687-27-NL (EUCTR) | 28/05/2020 | 18/05/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 5 | EUCTR2018-004614-18-LT (EUCTR) | 20/05/2020 | 25/11/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 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 | EUCTR2019-002687-27-HU (EUCTR) | 28/04/2020 | 09/03/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 7 | EUCTR2018-004614-18-DE (EUCTR) | 15/10/2019 | 25/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | ||
| 8 | EUCTR2018-004614-18-GB (EUCTR) | 16/09/2019 | 20/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia | ||
| 9 | EUCTR2018-004614-18-PL (EUCTR) | 03/09/2019 | 09/07/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 10 | NCT03926130 (ClinicalTrials.gov) | July 23, 2019 | 23/4/2019 | A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Mirikizumab;Drug: Ustekinumab;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 15 Years | 80 Years | All | 1150 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 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 |
| 11 | EUCTR2016-002204-84-BE (EUCTR) | 02/05/2017 | 06/02/2017 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 12 | EUCTR2016-002204-84-PL (EUCTR) | 27/04/2017 | 20/01/2017 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | |||
| 13 | EUCTR2016-002204-84-NL (EUCTR) | 25/04/2017 | 08/12/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | |||
| 14 | EUCTR2016-002204-84-AT (EUCTR) | 22/03/2017 | 11/11/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: LY3074828 Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 15 | EUCTR2016-002204-84-CZ (EUCTR) | 02/02/2017 | 13/10/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, 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 |
| 16 | EUCTR2016-002204-84-GB (EUCTR) | 01/02/2017 | 30/09/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | |||
| 17 | EUCTR2016-002204-84-HU (EUCTR) | 19/01/2017 | 09/11/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | |||
| 18 | NCT02891226 (ClinicalTrials.gov) | December 14, 2016 | 1/9/2016 | A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY) | Crohn's Disease | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | NULL | Active, not recruiting | 18 Years | 75 Years | All | 180 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France |
| 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 | NCT04469062 (ClinicalTrials.gov) | April 20, 2021 | 10/7/2020 | A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis | A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SC | Eli Lilly and Company | NULL | Not yet recruiting | 18 Years | 80 Years | All | 1100 | Phase 3 | NULL |
| 2 | EUCTR2017-004092-31-AT (EUCTR) | 02/07/2020 | 20/09/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 3 | NCT04004611 (ClinicalTrials.gov) | May 18, 2020 | 29/6/2019 | A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) | Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 17 Years | All | 30 | Phase 2 | United States;Canada;Israel;Japan;Korea, Republic of |
| 4 | EUCTR2017-004092-31-DE (EUCTR) | 05/09/2019 | 15/05/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan | ||
| 5 | EUCTR2017-004092-31-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Lilly S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 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 | EUCTR2017-004092-31-PL (EUCTR) | 08/01/2019 | 17/10/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Japan | ||
| 7 | EUCTR2017-003229-14-DK (EUCTR) | 20/11/2018 | 11/10/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly Cork Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan | ||
| 8 | EUCTR2017-003229-14-DE (EUCTR) | 15/10/2018 | 30/04/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania | ||
| 9 | EUCTR2017-003238-96-DE (EUCTR) | 15/10/2018 | 03/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 10 | EUCTR2017-004092-31-NL (EUCTR) | 10/10/2018 | 01/06/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan | ||
| 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 |
| 11 | EUCTR2017-003229-14-HU (EUCTR) | 27/09/2018 | 15/06/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | ||
| 12 | EUCTR2017-004092-31-BE (EUCTR) | 13/09/2018 | 07/06/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 13 | EUCTR2017-003229-14-CZ (EUCTR) | 16/08/2018 | 30/05/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India | ||
| 14 | JPRN-JapicCTI-184062 | 02/8/2018 | 10/08/2018 | I6T-MC-AMAP | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Mirikizumab administered subcutaneously (SC) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Eli Lilly Japan K.K. | NULL | recruiting | 18 | 80 | BOTH | 142 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Middle East |
| 15 | EUCTR2017-003238-96-ES (EUCTR) | 01/08/2018 | 04/06/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 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 |
| 16 | EUCTR2017-003238-96-NL (EUCTR) | 24/07/2018 | 14/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | ||
| 17 | EUCTR2017-003229-14-ES (EUCTR) | 24/07/2018 | 04/06/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 18 | EUCTR2017-003229-14-LT (EUCTR) | 05/07/2018 | 31/05/2018 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1160 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 19 | EUCTR2017-004092-31-LT (EUCTR) | 05/07/2018 | 25/05/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan | ||
| 20 | EUCTR2017-003238-96-LT (EUCTR) | 05/07/2018 | 31/05/2018 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1044 | Phase 3 | United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 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 |
| 21 | EUCTR2017-004092-31-GB (EUCTR) | 25/06/2018 | 14/05/2018 | A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis | I6T-MC-AMAPA Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately toSeverely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3 | moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Germany;Japan | ||
| 22 | JPRN-JapicCTI-163356 | 29/9/2016 | 23/08/2016 | I6T-MC-AMAC | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Induction:High, Mid or Low dose LY3074828. Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:LY3074828 dose schedule1 or 2. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction:Placebo Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:Placebo | Eli Lilly Japan K.K. | NULL | complete | 18 | 75 | BOTH | 30 | Phase 2 | Japan, North America, Europe, Oceania |
| 23 | EUCTR2015-003123-57-PL (EUCTR) | 26/08/2016 | 16/05/2016 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 24 | EUCTR2015-003123-57-DK (EUCTR) | 03/06/2016 | 22/03/2016 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 25 | EUCTR2015-003123-57-NL (EUCTR) | 02/06/2016 | 12/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | ||
| 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 |
| 26 | EUCTR2015-003123-57-GB (EUCTR) | 29/03/2016 | 04/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 27 | EUCTR2015-003123-57-BE (EUCTR) | 09/02/2016 | 01/10/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 28 | EUCTR2015-003123-57-CZ (EUCTR) | 14/01/2016 | 05/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 29 | EUCTR2015-003123-57-HU (EUCTR) | 05/01/2016 | 06/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 30 | EUCTR2015-003123-57-LT (EUCTR) | 31/12/2015 | 17/11/2015 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 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 |
| 31 | NCT02589665 (ClinicalTrials.gov) | December 9, 2015 | 27/10/2015 | A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 75 Years | All | 249 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Denmark;France;Georgia;Hungary;Japan;Lithuania;Moldova, Republic of;Netherlands;Poland;Romania;United Kingdom;Czech Republic;Puerto Rico;Russian Federation;Ukraine |
| 32 | JPRN-JapicCTI-184216 | 22/11/2018 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMAN) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMAN) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection | Eli Lilly Japan K.K. | NULL | recruiting | 18 | 80 | BOTH | Phase 3 | NULL | ||
| 33 | JPRN-JapicCTI-184217 | 22/11/2018 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection, Subcutaneous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection, Subcutaneous injection | Eli Lilly Japan K.K. | NULL | pending | 18 | 80 | BOTH | Phase 3 | NULL |