ABBV-006 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 97 | 潰瘍性大腸炎 | 19 |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2016-004676-22-FR (EUCTR) | 09/03/2021 | 26/01/2021 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 2 | EUCTR2016-004676-22-BG (EUCTR) | 30/07/2019 | 14/05/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 3 | EUCTR2016-004676-22-SI (EUCTR) | 20/05/2019 | 06/02/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 760 | Phase 3 | Bulgaria;Germany;New Zealand;Japan;Sweden;Romania;Croatia;United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium | ||
| 4 | EUCTR2016-004676-22-HR (EUCTR) | 01/02/2019 | 16/05/2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 760 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 5 | EUCTR2016-004676-22-DE (EUCTR) | 22/01/2019 | 15/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 6 | EUCTR2016-004676-22-BE (EUCTR) | 14/01/2019 | 04/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065” | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 7 | EUCTR2016-004676-22-GB (EUCTR) | 20/12/2018 | 03/07/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 8 | EUCTR2016-004676-22-DK (EUCTR) | 15/11/2018 | 02/05/2018 | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 760 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 9 | EUCTR2016-004676-22-GR (EUCTR) | 26/10/2018 | 04/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Bulgaria;Germany;Japan;New Zealand;Sweden;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey | ||
| 10 | EUCTR2016-004676-22-SE (EUCTR) | 02/10/2018 | 16/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 11 | EUCTR2016-004676-22-NL (EUCTR) | 26/09/2018 | 02/05/2018 | 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 Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | United States;Portugal;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 12 | EUCTR2016-004676-22-LV (EUCTR) | 30/08/2018 | 29/08/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 13 | EUCTR2016-004676-22-LT (EUCTR) | 23/08/2018 | 26/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 14 | EUCTR2016-004676-22-IT (EUCTR) | 02/08/2018 | 21/01/2022 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 - na | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: [ABBV-006] 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 | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 15 | EUCTR2016-004676-22-PT (EUCTR) | 16/07/2018 | 02/07/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 16 | EUCTR2016-004676-22-AT (EUCTR) | 25/06/2018 | 06/04/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Czechia;Slovenia;Lithuania;Turkey;Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 17 | EUCTR2016-004676-22-ES (EUCTR) | 05/06/2018 | 13/04/2018 | NA | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 760 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 18 | EUCTR2016-004676-22-PL (EUCTR) | 15/06/2018 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis | 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 Ulcerative Colitis | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 942 | Phase 3 | Croatia;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden;Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland | |||
| 19 | EUCTR2016-004676-22-CZ (EUCTR) | 01/06/2018 | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 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 | 760 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden |