96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215

  
27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002687-27-HR
(EUCTR)
10/03/202214/03/2022A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
2EUCTR2019-002687-27-LT
(EUCTR)
03/09/202129/06/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
3JPRN-jRCT2031210210
16/08/202128/07/2021A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's DiseaseA master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ Ulcerative Colitis / Crohn's Disease
-
Drug: Mirikizumab
Administered SC
Other Name: LY3074828
Yoshimoto YusukeNULLRecruitingNot applicableNot applicableBoth5Phase 3United States;Japan
4EUCTR2019-002687-27-DE
(EUCTR)
27/07/202113/04/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
5EUCTR2019-002687-27-LV
(EUCTR)
17/06/202111/03/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Israel;Switzerland;Italy;India;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation
6EUCTR2019-002687-27-FR
(EUCTR)
10/06/202104/05/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
7NCT04844606
(ClinicalTrials.gov)
May 26, 202112/4/2021A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Crohn's DiseaseDrug: MirikizumabEli Lilly and CompanyNULLRecruiting2 Years19 YearsAll185Phase 3United States;Israel;Japan;Korea, Republic of
8EUCTR2019-002687-27-IT
(EUCTR)
18/05/202130/07/2021A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
9EUCTR2019-002687-27-SK
(EUCTR)
25/02/202108/12/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
10EUCTR2018-004614-18-DK
(EUCTR)
08/09/202005/08/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
11EUCTR2018-004614-18-HR
(EUCTR)
24/08/202023/11/2020Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United 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
12NCT04232553
(ClinicalTrials.gov)
June 22, 202015/1/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's DiseaseCrohn's DiseaseDrug: MirikizumabEli Lilly and CompanyNULLRecruiting18 YearsN/AAll778Phase 3United 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;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom
13EUCTR2019-002687-27-NL
(EUCTR)
28/05/202018/05/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
14EUCTR2018-004614-18-LT
(EUCTR)
20/05/202025/11/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
15EUCTR2019-002687-27-HU
(EUCTR)
28/04/202009/03/2020A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
778Phase 3United 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
16EUCTR2018-004614-18-LV
(EUCTR)
19/02/202012/12/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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
17EUCTR2018-004614-18-NL
(EUCTR)
21/10/201927/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
18EUCTR2018-004614-18-DE
(EUCTR)
15/10/201925/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
19EUCTR2018-004614-18-IT
(EUCTR)
09/10/201930/07/2021Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: Mirikizumab
Trade Name: STELARA 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Product Name: MIRIKIZUMAB
Product Code: [
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
20EUCTR2018-004614-18-GB
(EUCTR)
16/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Russian 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
21EUCTR2018-004614-18-ES
(EUCTR)
12/09/201904/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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
22EUCTR2018-004614-18-FR
(EUCTR)
11/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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
23EUCTR2018-004614-18-PL
(EUCTR)
03/09/201909/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden
24EUCTR2018-004614-18-HU
(EUCTR)
25/07/201911/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Sweden
25NCT03926130
(ClinicalTrials.gov)
July 23, 201923/4/2019A Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA 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 DiseaseCrohn's DiseaseDrug: Mirikizumab;Drug: Ustekinumab;Drug: PlaceboEli Lilly and CompanyNULLRecruiting15 Years80 YearsAll1150Phase 3United 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;Switzerland;Turkey;Ukraine;United Kingdom;Sweden
26EUCTR2018-004614-18-AT
(EUCTR)
10/07/201928/05/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
27NCT02891226
(ClinicalTrials.gov)
December 14, 20161/9/2016A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's DiseaseA Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)Crohn's DiseaseDrug: Mirikizumab;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years75 YearsAll191Phase 2United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France