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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-002674-26-GB (EUCTR) | 02/12/2020 | 26/11/2020 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | 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;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 2 | EUCTR2020-002674-26-AT (EUCTR) | 23/11/2020 | 18/11/2020 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | 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;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 3 | EUCTR2020-002674-26-NL (EUCTR) | 29/10/2020 | 15/09/2020 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United 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 | ||
| 4 | NCT04524611 (ClinicalTrials.gov) | September 30, 2020 | 20/8/2020 | Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) | 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 | Crohn's Disease (CD) | Drug: Risankizumab;Drug: Ustekinumab | AbbVie | NULL | Recruiting | 18 Years | 80 Years | All | 517 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 5 | NCT04254783 (ClinicalTrials.gov) | February 16, 2020 | 3/2/2020 | A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis (UC);Crohn's Disease | Drug: Risankizumab;Drug: Cytochrome P450 (CYP) Substrates | AbbVie | NULL | Recruiting | 18 Years | 80 Years | All | 20 | Phase 1 | United States;Germany;Israel |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2016-003191-50-FR (EUCTR) | 17/07/2019 | 28/01/2019 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 959 | Phase 3 | Belarus;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 | ||
| 7 | NCT03914261 (ClinicalTrials.gov) | July 1, 2019 | 11/4/2019 | Expanded Access to Risankizumab | Expanded Access to Risankizumab | Crohn's Disease;Ulcerative Colitis (UC) | Drug: Risankizumab | AbbVie | NULL | Available | 18 Years | N/A | All | Belgium;Israel;Spain;Switzerland;United States | ||
| 8 | EUCTR2016-003190-17-FR (EUCTR) | 07/05/2019 | 14/03/2019 | A 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | |||
| 9 | EUCTR2016-003191-50-SE (EUCTR) | 22/07/2018 | 14/09/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| 10 | EUCTR2016-003123-32-SE (EUCTR) | 09/07/2018 | 08/09/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2016-003191-50-HR (EUCTR) | 14/05/2018 | 29/05/2018 | A 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 M15-989 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;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 | ||
| 12 | EUCTR2016-003123-32-HR (EUCTR) | 14/05/2018 | 29/05/2018 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| 13 | EUCTR2016-003123-32-LT (EUCTR) | 07/05/2018 | 23/01/2018 | A 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;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 | ||
| 14 | EUCTR2016-003191-50-LT (EUCTR) | 07/05/2018 | 01/02/2018 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;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 | ||
| 15 | EUCTR2016-003190-17-HR (EUCTR) | 04/05/2018 | 16/05/2019 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | United 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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03105102 (ClinicalTrials.gov) | April 9, 2018 | 4/4/2017 | A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease | A 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 | Drug: Placebo for Risankizumab SC;Drug: Risankizumab IV;Drug: Placebo for Risankizumab IV;Drug: Risankizumab SC | AbbVie | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 1250 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey |
| 17 | EUCTR2016-003190-17-IE (EUCTR) | 06/02/2018 | 25/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | United 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 | ||
| 18 | EUCTR2016-003123-32-IE (EUCTR) | 06/02/2018 | 25/07/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| 19 | EUCTR2016-003191-50-IE (EUCTR) | 06/02/2018 | 25/07/2017 | A 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 M15-989 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| 20 | EUCTR2016-003123-32-BE (EUCTR) | 01/02/2018 | 08/08/2017 | A 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 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Belarus;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2016-003191-50-BE (EUCTR) | 01/02/2018 | 14/02/2018 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Belarus;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 | ||
| 22 | EUCTR2016-003190-17-BE (EUCTR) | 01/02/2018 | 14/02/2018 | A 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Estonia;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 | |||
| 23 | EUCTR2016-003190-17-GR (EUCTR) | 16/01/2018 | 15/11/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| 24 | EUCTR2016-003191-50-GR (EUCTR) | 16/01/2018 | 16/11/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Belarus;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 | ||
| 25 | EUCTR2016-003123-32-GR (EUCTR) | 16/01/2018 | 08/11/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 940 | Phase 3 | Belarus;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2016-003191-50-NL (EUCTR) | 15/01/2018 | 08/08/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;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 | ||
| 27 | EUCTR2016-003191-50-DE (EUCTR) | 09/01/2018 | 20/07/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;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 | ||
| 28 | EUCTR2016-003123-32-DE (EUCTR) | 09/01/2018 | 19/07/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | 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;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 | ||
| 29 | EUCTR2016-003190-17-DE (EUCTR) | 09/01/2018 | 19/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | 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;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 30 | EUCTR2016-003190-17-LT (EUCTR) | 29/12/2017 | 17/10/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Serbia;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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03104413 (ClinicalTrials.gov) | December 18, 2017 | 4/4/2017 | A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | 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 | Drug: placebo for risankizumab IV;Drug: risankizumab SC;Drug: risankizumab IV | AbbVie | NULL | Active, not recruiting | 16 Years | 80 Years | All | 618 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey |
| 32 | EUCTR2016-003191-50-GB (EUCTR) | 28/11/2017 | 24/07/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;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 | ||
| 33 | EUCTR2016-003123-32-GB (EUCTR) | 28/11/2017 | 20/07/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| 34 | EUCTR2016-003190-17-GB (EUCTR) | 28/11/2017 | 20/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | 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;Belarus;Portugal;Hong Kong;Taiwan | ||
| 35 | EUCTR2016-003190-17-EE (EUCTR) | 13/11/2017 | 30/08/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2016-003190-17-BG (EUCTR) | 08/11/2017 | 28/07/2017 | A 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| 37 | EUCTR2016-003123-32-BG (EUCTR) | 08/11/2017 | 28/07/2017 | A 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | 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;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 | ||
| 38 | EUCTR2016-003191-50-BG (EUCTR) | 08/11/2017 | 27/07/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;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 | ||
| 39 | EUCTR2016-003190-17-NL (EUCTR) | 07/11/2017 | 10/08/2017 | A 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Serbia;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;Latvia;Netherlands;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 | |||
| 40 | EUCTR2016-003123-32-ES (EUCTR) | 25/10/2017 | 20/10/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 940 | Phase 3 | Belarus;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2016-003191-50-ES (EUCTR) | 25/10/2017 | 20/10/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Belarus;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 | ||
| 42 | EUCTR2016-003190-17-ES (EUCTR) | 25/10/2017 | 20/10/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| 43 | EUCTR2016-003191-50-EE (EUCTR) | 10/10/2017 | 10/08/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 959 | Phase 3 | Belarus;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 | ||
| 44 | EUCTR2016-003123-32-EE (EUCTR) | 10/10/2017 | 28/08/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Belarus;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 | ||
| 45 | EUCTR2016-003190-17-CZ (EUCTR) | 02/10/2017 | 19/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2016-003123-32-SK (EUCTR) | 15/09/2017 | 23/05/2017 | A 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 940 | Phase 3 | Belarus;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 | ||
| 47 | EUCTR2016-003191-50-CZ (EUCTR) | 13/09/2017 | 21/07/2017 | A 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 M15-989 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 48 | EUCTR2016-003190-17-PT (EUCTR) | 28/08/2017 | 21/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Portugal;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 | ||
| 49 | EUCTR2016-003123-32-PT (EUCTR) | 28/08/2017 | 21/07/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Portugal;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 | ||
| 50 | EUCTR2016-003191-50-PT (EUCTR) | 28/08/2017 | 21/07/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2016-003190-17-AT (EUCTR) | 25/08/2017 | 31/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | United 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 | ||
| 52 | EUCTR2016-003123-32-AT (EUCTR) | 25/08/2017 | 31/07/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Norway;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 | ||
| 53 | EUCTR2016-003191-50-SK (EUCTR) | 23/08/2017 | 31/05/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;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 | ||
| 54 | EUCTR2016-003190-17-SK (EUCTR) | 23/08/2017 | 24/05/2017 | A 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: 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| 55 | EUCTR2016-003191-50-LV (EUCTR) | 18/08/2017 | 25/07/2017 | A 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 | A 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 959 | Phase 3 | Belarus;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2016-003191-50-AT (EUCTR) | 03/08/2017 | 31/07/2017 | A 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 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| 57 | EUCTR2016-003190-17-LV (EUCTR) | 31/07/2017 | 01/08/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;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 | ||
| 58 | EUCTR2016-003123-32-LV (EUCTR) | 31/07/2017 | 01/08/2017 | A 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 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 940 | Phase 3 | Belarus;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 | ||
| 59 | EUCTR2016-003190-17-DK (EUCTR) | 25/07/2017 | 19/07/2017 | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | United 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 | ||
| 60 | EUCTR2016-003191-50-DK (EUCTR) | 19/07/2017 | 18/07/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease | A 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. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | 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;Norway;Japan;New Zealand | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT03105128 (ClinicalTrials.gov) | May 10, 2017 | 4/4/2017 | A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease | A 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 | Drug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SC | AbbVie | NULL | Active, not recruiting | 16 Years | 80 Years | All | 931 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Finland;France;Hungary;Turkey |
| 62 | EUCTR2015-001834-15-DE (EUCTR) | 24/09/2015 | 14/08/2015 | A long term extension trial of BI 655066/ABBV-066 (risankizumab) in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066/ABBV-066 (risankizumab), in patients 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] | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 63 | NCT02513459 (ClinicalTrials.gov) | September 16, 2015 | 30/7/2015 | A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease | An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Risankizumab 600 mg IV;Drug: Risankizumab 180 mg SC | AbbVie | Boehringer Ingelheim | Completed | 18 Years | 75 Years | All | 65 | Phase 2 | United States;Belgium;Canada;Germany;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom |
| 64 | EUCTR2013-002902-29-DE (EUCTR) | 22/12/2014 | 08/08/2014 | Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: Risankizumab 10 mg/ml INN or Proposed INN: Risankizumab Product Code: Risankizumab 90 mg/ml INN or Proposed INN: Risankizumab | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 65 | NCT02031276 (ClinicalTrials.gov) | February 2014 | 16/12/2013 | Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease. | A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy | Crohn Disease | Drug: risankizumab IV;Drug: risankizumab SC;Drug: Placebo | AbbVie | Boehringer Ingelheim | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Belgium;Canada;France;Germany;Ireland;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom;United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2016-003123-32-CZ (EUCTR) | 19/07/2017 | A 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 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] | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 855 | Phase 3 | Belarus;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 | ||||
| 67 | EUCTR2016-003123-32-PL (EUCTR) | 02/08/2017 | A 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 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. KG | NULL | NA | Female: yes Male: yes | 855 | Phase 3 | 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;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| 68 | EUCTR2016-003191-50-PL (EUCTR) | 03/08/2017 | A 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 | A 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. KG | NULL | NA | Female: yes Male: yes | 1250 | Phase 3 | 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;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 | |||
| 69 | EUCTR2016-003190-17-PL (EUCTR) | 01/08/2017 | A 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. KG | NULL | NA | Female: yes Male: yes | 579 | Phase 3 | United 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 | |||
| 70 | EUCTR2016-003191-50-NO (EUCTR) | 16/11/2017 | A 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 M15-989 | A 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. KG | NULL | NA | Female: yes Male: yes | 1250 | Phase 3 | 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;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2016-003123-32-NO (EUCTR) | 16/11/2017 | A 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 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. KG | NULL | NA | Female: yes Male: yes | 855 | Phase 3 | 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;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| 72 | EUCTR2016-003123-32-NL (EUCTR) | 10/08/2017 | A 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 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. KG | NULL | NA | Female: yes Male: yes | 855 | Phase 3 | 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;Norway;Japan;New Zealand |