GUSELKUMAB ( DrugBank: Guselkumab )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 37 | 膿疱性乾癬（汎発型） | 7 |
| 41 | 巨細胞性動脈炎 | 3 |
| 51 | 全身性強皮症 | 2 |
| 96 | クローン病 | 36 |
| 97 | 潰瘍性大腸炎 | 23 |
37. 膿疱性乾癬（汎発型）
臨床試験数 : 79 / 薬物数 : 57 - (DrugBank : 21) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
Showing 1 to 7 of 7 diseases
| 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 | NCT03998683 (ClinicalTrials.gov) | September 3, 2019 | 25/6/2019 | A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis | A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Effi ... | Psoriasis | Drug: Guselkumab 100 mg;Drug: Placebo | Janssen-Cilag Ltd. | NULL | Completed | 18 Years | N/A | All | 117 | Phase 3 | France;Germany;Italy;Spain;United Kingdom |
| 2 | EUCTR2018-003206-58-GB (EUCTR) | 29/07/2019 | 28/05/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis A Clinical Study to Evaluate the Efficacy and Safety of Guselkumabfor the Treatment of Palmoplantar ... | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Effi ... | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term ... | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Oth ... | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | France;Spain;Germany;United Kingdom | ||
| 3 | EUCTR2018-003206-58-IT (EUCTR) | 11/07/2019 | 15/06/2021 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis A Clinical Study to Evaluate the Efficacy and Safety of Guselkumabfor the Treatment of Palmoplantar ... | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Effi ... | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term ... | Trade Name: TREMFYA Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB Trade Name: TREMFYA Product Name: GUSELKUMAB Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Ot ... | JANSSEN CILAG INTERNATIONAL NV | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | France;Spain;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-003206-58-DE (EUCTR) | 02/07/2019 | 25/04/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis A Clinical Study to Evaluate the Efficacy and Safety of Guselkumabfor the Treatment of Palmoplantar ... | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Effi ... | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term ... | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Oth ... | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | France;Spain;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2018-003206-58-FR (EUCTR) | 29/06/2019 | 11/04/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis A Clinical Study to Evaluate the Efficacy and Safety of Guselkumabfor the Treatment of Palmoplantar ... | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Effi ... | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term ... | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Oth ... | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;Spain;Germany;United Kingdom | ||
| 6 | EUCTR2018-003206-58-ES (EUCTR) | 20/06/2019 | 08/05/2019 | A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis A Clinical Study to Evaluate the Efficacy and Safety of Guselkumabfor the Treatment of Palmoplantar ... | A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - G-PLUS A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Effi ... | Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Palmoplantar non-Pustular Psoriasis MedDRA version: 20.0;Level: PT;Classification code 10037153;Term ... | Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Other descriptive name: GUSELKUMAB Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Oth ... | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;Spain;Germany;United Kingdom | ||
| 7 | NCT02343744 (ClinicalTrials.gov) | January 19, 2015 | 16/1/2015 | An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generali ... | A Phase 3, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of CNTO1959 (Guselkumab) in the Treatment of Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis A Phase 3, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of CNTO1959 (Guselkumab) ... | Pustular Psoriasis | Drug: Guselkumab | Janssen Pharmaceutical K.K. | NULL | Completed | 20 Years | N/A | All | 21 | Phase 3 | Japan |
41. 巨細胞性動脈炎
臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
Showing 1 to 3 of 3 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-000622-26-DE (EUCTR) | 22/01/2021 | 17/09/2020 | A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis A Proof-of-Concept Study of Guselkumabin the Treatment of Subjects with New-Onset or Relapsing Giant ... | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis - THEIA A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Eval ... | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell ar ... | 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: Guselkuma ... | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;France;Canada;Spain;Poland;Belgium;Israel;Germany;Italy | ||
| 2 | EUCTR2020-000622-26-IT (EUCTR) | 18/12/2020 | 24/05/2021 | A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis A Proof-of-Concept Study of Guselkumabin the Treatment of Subjects with New-Onset or Relapsing Giant ... | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis - THEIA A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Eval ... | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02] Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell ar ... | Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive name: * D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg Product Name: Guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Other descriptive nam ... | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Germany;Italy | ||
| 3 | NCT04633447 (ClinicalTrials.gov) | December 10, 2020 | 6/11/2020 | A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis A Study to Evaluate Guselkumabfor the Treatment of Participants With New-onset or Relapsing Giant Ce ... | A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Eval ... | Giant Cell Arteritis | Drug: Guselkumab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 50 Years | N/A | All | 51 | Phase 2 | United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain |
51. 全身性強皮症
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
Showing 1 to 2 of 2 diseases
| 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 | JPRN-jRCT2051200133 | 31/03/2021 | 12/02/2021 | A study of Guselkumab in Participants with Systemic Sclerosis | A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants with Systemic Sclerosis A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumabin ... | Scleroderma, Systemic | Group A: Guselkumab Dose 1 Guselkumab Dose 1 will be administered intravenously. Group A: Guselkumab Dose 2 Guselkumab Dose 2 will be administered subcutaneously. Group B: Placebo Placebo will be administered intravenously or subcutaneously. Group A: GuselkumabDose 1 GuselkumabDose 1 will be administered intravenously. Group A: GuselkumabDose ... | Numaguchi Hirotaka | NULL | Not Recruiting | >= 18age old | <= 75age old | Both | 56 | Phase 2 | Japan |
| 2 | NCT04683029 (ClinicalTrials.gov) | February 24, 2021 | 22/12/2020 | A Study of Guselkumab in Participants With Systemic Sclerosis | A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic Sclerosis A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumabin ... | Scleroderma, Systemic | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Placebo | Janssen Pharmaceutical K.K. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 56 | Phase 2 | Japan |
96. クローン病
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
Showing 1 to 10 of 36 diseases
| 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 Efficacy and Safety of Combination Therapy with Guselkumaband Golimumab in Participants with Moderat ... | 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 A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | 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] Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 100 ... | 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 Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Pr ... | 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 Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel ... | ||
| 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 GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of GuselkumabSubcutaneous Induction Th ... | 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 A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Ef ... | 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] Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 100 ... | 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: ... | 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 Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jo ... | ||
| 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 Efficacy and Safety of Combination Therapy with Guselkumaband Golimumab in Participants with Moderat ... | 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 A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | 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] Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 100 ... | 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 Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Pr ... | 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 Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel ... | ||
| 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 Study of Combination Therapy with Guselkumaband Golimumab in Participants with Moderately to Sever ... | 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 A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | 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 Guselkumab Guselkumabwill be administered as subcutaneous injection. Participants will receive guselku ... | 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 Argentina;Australia;Austria;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;China;Czechia;Germany;D ... |
| 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 GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of GuselkumabSubcutaneous Induction Th ... | 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 A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Ef ... | 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] Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 100 ... | 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: ... | 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 Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jo ... | ||
| 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 A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficac ... | 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 Portugal;Saudi Arabia;Spain;United States;Australia;Belgium;Canada;Czechia;Egypt;France;Germany;Gree ... |
| 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 A Phase 3,Randomized,Placebo-controlled,Parallel-group,Multicenter Study to Evaluate the Efficacy an ... | 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. Guselkumab:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Guselkumabwill be administe ... | 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 Australia;Spain;Italy;Saudi Arabia;Belgium;France;Jordan;Sweden;Canada;United Kingdom Of Great Brita ... |
| 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 Study of GuselkumabSubcutaneous Therapy in Participants with Moderately to Severely Active Crohn's ... | 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 A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Ef ... | 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. GuselkumabDose 1:Drug:Group 1: Guselkumab,Group 2: Guselkumab:Guselkumab(Dose 1) will be administere ... | 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 Australia;Belarus;Belgium;Bosnia And Herzegovina;Brazil;Canada;China;Croatia;Czechia;Germany;Hungary ... |
| 9 | 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 Study of Combination Therapy With Guselkumaband Golimumab in Participants With Moderately to Sever ... | 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 A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | 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 United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Croatia;Czechia ... |
| 10 | 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 GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of GuselkumabSubcutaneous Induction Th ... | 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 A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Ef ... | 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] Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 100 ... | 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: ... | 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 United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Jo ... |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
Showing 1 to 10 of 23 diseases
| 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 | EUCTR2021-005528-39-NL (EUCTR) | 14/12/2022 | 12/09/2022 | Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis Efficacy and Safety of Combination Therapy with Guselkumaband Golimumab in Participants with Moderat ... | 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 Ulcerative Colitis - DUET-UC A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | 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] - Immune System Diseases [C20] Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code ... | 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 Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Pr ... | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 2 | Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Jordan;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Switzerland;Malaysia;Australia;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Bulgaria;Georgia;Germany;Norway;New Zealand;Japan Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Jordan;Denmark;Latvia;Kor ... | ||
| 2 | JPRN-jRCT2031220308 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis A Study of Combination Therapy with Guselkumaband Golimumab in Participants with Moderately to Sever ... | 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 Ulcerative Colitis - DUET-UC A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | Colitis, Ulcerative | 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 Guselkumab Guselkumabwill be administered as subcutaneous injection. Participants will receive guselku ... | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 550 | Phase 2 | Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmar ... |
| 3 | NCT05242484 (ClinicalTrials.gov) | September 19, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis A Study of Combination Therapy With Guselkumaband Golimumab in Participants With Moderately to Sever ... | 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 Ulcerative Colitis A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | Colitis, Ulcerative | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 65 Years | All | 550 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Lithuania United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Croatia;Czechia;Denma ... |
| 4 | NCT05528510 (ClinicalTrials.gov) | September 13, 2022 | 19/8/2022 | A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3, 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 Ulcerative Colitis A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evalua ... | Colitis, Ulcerative | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Other: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 400 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;India;Israel;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Poland;Slovakia;Spain;Taiwan;Turkey;Italy;Malaysia;Portugal;Serbia;Sweden United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungar ... |
| 5 | 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 Study of the Efficacy and Safety of Guselkumabin Participants with Moderately to Severely Active U ... | 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 A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to ... | 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] Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code ... | 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 Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkuma ... | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Serbia;Portugal;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;Belgium;Brazil;Poland;Bulgaria;Germany;New Zealand;Japan;Sweden Serbia;Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy; ... | ||
| 6 | 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 Study of the Efficacy and Safety of Guselkumabin Participants with Moderately to Severely Active U ... | 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 A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to ... | 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] Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code ... | 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 Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkuma ... | 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 Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy; ... | ||
| 7 | EUCTR2018-004002-25-AT (EUCTR) | 12/05/2021 | 21/12/2020 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis A Study of the Efficacy and Safety of Guselkumabin Participants with Moderately to Severely Active U ... | 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 A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to ... | 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] Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code ... | 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 Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkuma ... | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 2;Phase 3 | Japan;New Zealand;Sweden;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;United States;Serbia;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian ... | ||
| 8 | 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 Study of the Efficacy and Safety of Guselkumabin Participants with Moderately to Severely Active U ... | 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 A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to ... | 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] Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code ... | 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 Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkuma ... | 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 Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy; ... | ||
| 9 | JPRN-JapicCTI-194980 | 22/5/2020 | 30/09/2019 | A Study 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 A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to ... | Ulcerative Colitis | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC. Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the i ... | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 1000 | Phase 2-3 | Japan, Asia except Japan, North America, Europe | |
| 10 | 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 Study of the Efficacy and Safety of Guselkumabin Participants with Moderately to Severely Active U ... | 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 A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to ... | 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] Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code ... | 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 Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkuma ... | 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 United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia ... |