96. Crohn disease Clinical trials / Disease details


Clinical trials : 2,400 Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215

  
22 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002674-26-DE
(EUCTR)
19/05/202117/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
2EUCTR2020-002674-26-SK
(EUCTR)
14/01/202120/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
3EUCTR2020-002674-26-CZ
(EUCTR)
13/01/202118/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
4EUCTR2020-002674-26-HU
(EUCTR)
06/01/202120/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
5EUCTR2020-002674-26-IT
(EUCTR)
10/12/202021/05/2021A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. - NA Crohns 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: Risankizumab
Product Code: [ABBV-066]
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: [ABBV-066]
INN or Proposed INN: RISANKIZUMAB
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
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
6EUCTR2020-002674-26-GB
(EUCTR)
02/12/202026/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
7EUCTR2020-002674-26-AT
(EUCTR)
23/11/202018/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada
8EUCTR2020-002674-26-SE
(EUCTR)
19/11/202013/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
9EUCTR2020-002674-26-NL
(EUCTR)
29/10/202015/09/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns 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: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
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
12EUCTR2018-004614-18-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
13EUCTR2019-001337-13-FR
(EUCTR)
18/03/202002/03/2020USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD studyUSTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: STELARA
Trade Name: STELARA 90 mg solution for injection in pre-filled syringe
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
146Phase 4France
14EUCTR2018-004614-18-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
15EUCTR2018-004614-18-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
16EUCTR2018-004614-18-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
17EUCTR2018-004614-18-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
18EUCTR2018-004614-18-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
19EUCTR2018-004614-18-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
20EUCTR2018-004614-18-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
21EUCTR2018-004614-18-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
22EUCTR2018-004614-18-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