97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 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 | EUCTR2018-004002-25-SK (EUCTR) | 28/05/2021 | 13/01/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 2 | EUCTR2018-004002-25-LV (EUCTR) | 27/05/2021 | 02/02/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan;Sweden | ||
| 3 | EUCTR2018-004002-25-NL (EUCTR) | 06/07/2020 | 17/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 4 | EUCTR2018-004002-25-BG (EUCTR) | 13/05/2020 | 24/02/2020 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 5 | EUCTR2018-004002-25-DE (EUCTR) | 07/04/2020 | 23/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 6 | EUCTR2018-004002-25-ES (EUCTR) | 28/02/2020 | 04/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden | ||
| 7 | EUCTR2018-004002-25-PT (EUCTR) | 03/02/2020 | 06/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden | ||
| 8 | EUCTR2018-004002-25-BE (EUCTR) | 21/10/2019 | 10/09/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 9 | EUCTR2018-004002-25-SE (EUCTR) | 15/10/2019 | 03/07/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 10 | EUCTR2018-004002-25-FR (EUCTR) | 15/10/2019 | 14/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden | ||
| 11 | EUCTR2018-004002-25-GB (EUCTR) | 09/10/2019 | 20/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 2;Phase 3 | Germany;Japan;Sweden;Bulgaria;Romania;Poland;Belgium;Brazil;Argentina;Canada;Hungary;Czech Republic;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Taiwan;Portugal;United States | ||
| 12 | EUCTR2018-004002-25-HU (EUCTR) | 01/10/2019 | 13/08/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR | Moderately to Severely Active 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: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Bulgaria;Germany;Japan;Sweden;Belgium;Poland;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;Malaysia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Thailand;Hong Kong;Taiwan;United States;Portugal | ||
| 13 | EUCTR2018-001510-15-DE (EUCTR) | 02/05/2019 | 19/11/2018 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | 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: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany | ||
| 14 | EUCTR2018-001510-15-PL (EUCTR) | 01/03/2019 | 04/02/2019 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | 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: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany |