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 | JPRN-jRCT2031220309 | 01/11/2022 | 01/09/2022 | A Study 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 | Crohn's Disease | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 715 | Phase 2 | Argentina;Australia;Austria;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;China;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Serbia;Japan |
| 5 | 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 | ||
| 6 | NCT05347095 (ClinicalTrials.gov) | September 27, 2022 | 21/4/2022 | A Study 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 | Fistulizing Crohns Disease;Perianal Crohns Disease | Drug: Guselkumab;Drug: Placebo | Janssen-Cilag Ltd. | NULL | Recruiting | 18 Years | N/A | All | 280 | Phase 3 | Portugal;Saudi Arabia;Spain;United States;Australia;Belgium;Canada;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Italy;Japan;Jordan;Korea, Republic of;Netherlands;Poland;Sweden;Taiwan;Turkey;United Kingdom |
| 7 | JPRN-jRCT2031220205 | 22/08/2022 | 08/07/2022 | A Study 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 CD | Fistulizing Crohns Disease Perianal Crohns Disease | Guselkumab:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Guselkumab will be administered subcutaneously/IV infusion. Placebo:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Matching placebo will be administered subcutaneously/IV infusion. | Numaguchi Hirotaka | NULL | Pending | >= 18age old | Not applicable | Both | 280 | Phase 3 | Australia;Spain;Italy;Saudi Arabia;Belgium;France;Jordan;Sweden;Canada;United Kingdom Of Great Britain;Republic Of Korea;Turkey;Czechia;Greece;Netherlands;Taiwan;Germany;Hungary;Poland;United States Of America;Egypt;Israel;Portugal;Japan |
| 8 | JPRN-jRCT2031210678 | 22/08/2022 | 18/03/2022 | A Study of Guselkumab Subcutaneous 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 - GRAVITI | Crohn Disease | Guselkumab Dose 1:Drug:Group 1: Guselkumab,Group 2: Guselkumab:Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab Dose 2:Drug:Group 1: Guselkumab:Guselkumab (Dose 2) will be administered by SC injection. Guselkumab Dose 3:Drug:Group 2: Guselkumab:Guselkumab (Dose 3) will be administered by SC injection. Placebo:Drug:Group 3: Placebo:Placebo will be administered by SC injection. | Hirotaka Numaguchi | NULL | Pending | >= 18age old | Not applicable | Both | 318 | Phase 3 | Australia;Belarus;Belgium;Bosnia And Herzegovina;Brazil;Canada;China;Croatia;Czechia;Germany;Hungary;Italy;Jordan;Korea;France;Lithuania;Netherlands;NewZealand;Poland;RussianFederation;Serbia;Slovakia;Spain;Taiwan,Province Of China;Turkey;Ukraine;United Kingdom Of Great Britain;UnitedStates Of America;Japan |
| 9 | 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 | ||
| 10 | NCT05242471 (ClinicalTrials.gov) | July 22, 2022 | 15/2/2022 | A Study 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 | Crohn's Disease | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 715 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Finland;Lithuania;Slovakia |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | NCT05197049 (ClinicalTrials.gov) | January 19, 2022 | 17/1/2022 | A Study of Guselkumab Subcutaneous 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 | Crohn Disease | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 318 | Phase 3 | United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Croatia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Jordan;Korea, Republic of;Lithuania;Malaysia;Netherlands;New Zealand;Norway;Poland;Serbia;Slovakia;Spain;Taiwan;Turkey;United Kingdom;Belarus;Bulgaria;Estonia;Finland;Mexico;Portugal;Russian Federation;Sweden;Ukraine |
| 16 | JPRN-JapicCTI-205298 | 10/6/2020 | 26/05/2020 | A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 25 | Phase 3 | Japan | |
| 17 | NCT04397263 (ClinicalTrials.gov) | June 10, 2020 | 18/5/2020 | A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | Crohns Disease | Drug: Guselkumab | Janssen Pharmaceutical K.K. | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 3 | Japan |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | EUCTR2017-002195-13-IT (EUCTR) | 05/11/2018 | 22/01/2021 | 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 Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB 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 | ||
| 21 | JPRN-JapicCTI-183950 | 20/9/2018 | 07/05/2018 | 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, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | Crohn's Disease | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion. Control intervention name : Ustekinumab INN of the control intervention : Ustekinumab Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion. | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 2000 | Phase 2-3 | Japan, North America | |
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | NCT03466411 (ClinicalTrials.gov) | April 13, 2018 | 8/3/2018 | 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 | Crohn's Disease | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Guselkumab Dose 4;Drug: Guselkumab Dose 5;Drug: Guselkumab;Drug: Ustekinumab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Active, not recruiting | 18 Years | N/A | All | 1409 | Phase 2/Phase 3 | Latvia;Lebanon;Lithuania;Malaysia;Netherlands;New Zealand;North Macedonia;Poland;Portugal;Puerto Rico;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;United States;Chile;Ireland;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;South Africa;Sweden;Switzerland;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;China;Colombia;Croatia;Czechia;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of |
| 35 | NCT02103361 (ClinicalTrials.gov) | November 2013 | 13/2/2014 | Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project | Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project | Psoriasis;Pregnancy;Psoriatic Arthritis;Crohn Disease | Drug: Ustekinumab;Drug: Guselkumab | University of California, San Diego | The Organization of Teratology Information Specialists;Janssen Biotech, Inc. | Recruiting | N/A | N/A | Female | 200 | United States | |
| 36 | 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 |