96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2021-003314-39-SI (EUCTR) | 22/12/2022 | 24/11/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease - DUET-CD | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 715 | Phase 2 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Georgia;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden | ||
| 2 | EUCTR2020-006165-11-HR (EUCTR) | 21/12/2022 | 05/01/2023 | GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 3 | Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jordan;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Canada;Brazil;Poland;Belgium;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 3 | EUCTR2021-003314-39-NL (EUCTR) | 14/12/2022 | 07/09/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease - DUET-CD | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 715 | Phase 2 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Jordan;Malaysia;Denmark;Australia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Georgia;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden | ||
| 4 | EUCTR2020-006165-11-DE (EUCTR) | 28/10/2022 | 27/05/2022 | GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 3 | Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jordan;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Canada;Brazil;Poland;Belgium;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 5 | EUCTR2020-006165-11-LT (EUCTR) | 22/07/2022 | 15/02/2022 | GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 3 | United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jordan;Australia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 6 | EUCTR2021-000491-10-HU (EUCTR) | 19/07/2022 | 31/05/2022 | FUZION - Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease | A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease - FUZION | Fistulizing perianal Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | United States;Portugal;Taiwan;Saudi Arabia;Greece;Spain;Ukraine;Lebanon;Israel;Russian Federation;Italy;France;Jordan;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Poland;Belgium;Germany;Japan;Sweden | ||
| 7 | EUCTR2020-006165-11-ES (EUCTR) | 19/04/2022 | 02/02/2022 | GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 3 | United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jordan;Australia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 8 | EUCTR2020-006165-11-NL (EUCTR) | 11/04/2022 | 17/02/2022 | GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 3 | United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jordan;Australia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 9 | EUCTR2020-006165-11-PL (EUCTR) | 27/03/2022 | 04/03/2022 | GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: GUSELKUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 3 | Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jordan;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Canada;Brazil;Poland;Belgium;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 10 | EUCTR2017-002195-13-GB (EUCTR) | 05/06/2019 | 28/02/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 11 | EUCTR2017-002195-13-PT (EUCTR) | 18/03/2019 | 23/07/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 12 | EUCTR2017-002195-13-NL (EUCTR) | 10/09/2018 | 30/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Latvia;Netherlands;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 13 | EUCTR2017-002195-13-HR (EUCTR) | 07/09/2018 | 16/05/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 14 | EUCTR2017-002195-13-PL (EUCTR) | 13/08/2018 | 25/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;North Macedonia;Israel;Colombia;Italy;Switzerland;India;France;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Croatia;Georgia;Norway;Germany;New Zealand;Japan;Sweden | ||
| 15 | EUCTR2017-002195-13-LV (EUCTR) | 10/08/2018 | 21/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 16 | EUCTR2017-002195-13-ES (EUCTR) | 30/07/2018 | 21/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 17 | EUCTR2017-002195-13-GR (EUCTR) | 27/07/2018 | 17/07/2018 | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Portugal;Serbia;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;North Macedonia;Israel;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 18 | EUCTR2017-002195-13-DE (EUCTR) | 03/07/2018 | 01/03/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 19 | EUCTR2017-002195-13-LT (EUCTR) | 28/06/2018 | 20/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 20 | EUCTR2017-002195-13-CZ (EUCTR) | 19/06/2018 | 20/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 21 | EUCTR2017-002195-13-SK (EUCTR) | 18/06/2018 | 26/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA INN or Proposed INN: ustekinumab Trade Name: STELARA INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 22 | EUCTR2017-002195-13-BE (EUCTR) | 15/06/2018 | 30/03/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 23 | EUCTR2017-002195-13-AT (EUCTR) | 28/05/2018 | 18/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;North Macedonia;Israel;Colombia;Italy;France;Jordan;Australia;South Africa;Tunisia;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 24 | EUCTR2021-006282-37-NO (EUCTR) | 17/11/2022 | Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease - MACARONI-23 | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 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 | NA | Female: yes Male: yes | 120 | Phase 3 | Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Norway;Netherlands;Japan;Korea, Republic of |