Tremfya ( DrugBank: - )


2 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)5
97潰瘍性大腸炎2

37. 膿疱性乾癬(汎発型)


臨床試験数 : 74 薬物数 : 53 - (DrugBank : 20) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 101
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003206-58-GB
(EUCTR)
29/07/201928/05/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA 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 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]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3France;Spain;Germany;United Kingdom
2EUCTR2018-003206-58-IT
(EUCTR)
11/07/201915/06/2021A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA 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 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]
Trade Name: TREMFYA
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
105Phase 3France;Spain;Germany;United Kingdom;Italy
3EUCTR2018-003206-58-DE
(EUCTR)
02/07/201925/04/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA 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 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]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
105Phase 3France;Spain;Germany;Italy;United Kingdom
4EUCTR2018-003206-58-FR
(EUCTR)
29/06/201911/04/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA 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 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]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLAuthorised-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): noFrance;Spain;Germany;United Kingdom
5EUCTR2018-003206-58-ES
(EUCTR)
20/06/201908/05/2019A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar PsoriasisA 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 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]
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Other descriptive name: GUSELKUMAB
Janssen-Cilag International N.V.NULLAuthorised-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): noFrance;Spain;Germany;United Kingdom

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001510-15-DE
(EUCTR)
02/05/201919/11/2018A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: Simponi®
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany
2EUCTR2018-001510-15-PL
(EUCTR)
01/03/201904/02/2019A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: Simponi®
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany