96. クローン病
[臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
56 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-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
2EUCTR2020-002674-26-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 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
3EUCTR2020-002674-26-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
4EUCTR2016-003191-50-FR
(EUCTR)
17/07/201928/01/2019A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
959Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
5EUCTR2016-003191-50-SE
(EUCTR)
22/07/201814/09/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-003123-32-SE
(EUCTR)
09/07/201808/09/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
7EUCTR2016-003191-50-HR
(EUCTR)
14/05/201829/05/2018A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan
8EUCTR2016-003123-32-HR
(EUCTR)
14/05/201829/05/2018A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
9EUCTR2016-003191-50-LT
(EUCTR)
07/05/201801/02/2018A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
10EUCTR2016-003123-32-LT
(EUCTR)
07/05/201823/01/2018A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-003190-17-HR
(EUCTR)
04/05/201816/05/2019A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
12EUCTR2016-003123-32-IE
(EUCTR)
06/02/201825/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
13EUCTR2016-003191-50-IE
(EUCTR)
06/02/201825/07/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
14EUCTR2016-003190-17-IE
(EUCTR)
06/02/201825/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
15EUCTR2016-003191-50-BE
(EUCTR)
01/02/201814/02/2018A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-003191-50-GR
(EUCTR)
16/01/201816/11/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
17EUCTR2016-003123-32-GR
(EUCTR)
16/01/201808/11/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
18EUCTR2016-003190-17-GR
(EUCTR)
16/01/201815/11/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
19EUCTR2016-003191-50-NL
(EUCTR)
15/01/201808/08/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan
20EUCTR2016-003190-17-DE
(EUCTR)
09/01/201819/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-003191-50-DE
(EUCTR)
09/01/201820/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
22EUCTR2016-003123-32-DE
(EUCTR)
09/01/201819/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
23EUCTR2016-003190-17-LT
(EUCTR)
29/12/201717/10/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Serbia;Portugal;United States;Belarus;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
24EUCTR2016-003191-50-GB
(EUCTR)
28/11/201724/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
25EUCTR2016-003123-32-GB
(EUCTR)
28/11/201720/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-003190-17-GB
(EUCTR)
28/11/201720/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Belarus;Portugal;Hong Kong;Taiwan
27EUCTR2016-003190-17-EE
(EUCTR)
13/11/201730/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
28EUCTR2016-003123-32-BG
(EUCTR)
08/11/201728/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
29EUCTR2016-003191-50-BG
(EUCTR)
08/11/201727/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
30EUCTR2016-003190-17-BG
(EUCTR)
08/11/201728/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-003190-17-ES
(EUCTR)
25/10/201720/10/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
32EUCTR2016-003191-50-ES
(EUCTR)
25/10/201720/10/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
912Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
33EUCTR2016-003123-32-ES
(EUCTR)
25/10/201720/10/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
34EUCTR2016-003191-50-EE
(EUCTR)
10/10/201710/08/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
959Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
35EUCTR2016-003123-32-EE
(EUCTR)
10/10/201728/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-003190-17-CZ
(EUCTR)
02/10/201719/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
37EUCTR2016-003123-32-SK
(EUCTR)
15/09/201723/05/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
38EUCTR2016-003191-50-CZ
(EUCTR)
13/09/201721/07/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
39EUCTR2016-003190-17-PT
(EUCTR)
28/08/201721/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
40EUCTR2016-003191-50-PT
(EUCTR)
28/08/201721/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-003123-32-PT
(EUCTR)
28/08/201721/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
42EUCTR2016-003123-32-AT
(EUCTR)
25/08/201731/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
855Phase 3Norway;Japan;New Zealand;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany
43EUCTR2016-003190-17-AT
(EUCTR)
25/08/201731/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
44EUCTR2016-003190-17-SK
(EUCTR)
23/08/201724/05/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Rizankisumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
45EUCTR2016-003191-50-SK
(EUCTR)
23/08/201731/05/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2016-003191-50-AT
(EUCTR)
03/08/201731/07/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
47EUCTR2016-003190-17-LV
(EUCTR)
31/07/201701/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand
48EUCTR2016-003123-32-LV
(EUCTR)
31/07/201701/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
940Phase 3Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
49EUCTR2016-003190-17-DK
(EUCTR)
25/07/201719/07/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
50EUCTR2016-003191-50-DK
(EUCTR)
19/07/201718/07/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2016-003123-32-PL
(EUCTR)
02/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
52EUCTR2016-003191-50-PL
(EUCTR)
03/08/2017A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
53EUCTR2016-003191-50-NO
(EUCTR)
16/11/2017A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
1250Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
54EUCTR2016-003123-32-NO
(EUCTR)
16/11/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand
55EUCTR2016-003190-17-PL
(EUCTR)
01/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
579Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2016-003123-32-NL
(EUCTR)
10/08/2017A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;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
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
AbbVie Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
855Phase 3Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand