Guselkumab Dose 1 ( DrugBank: Guselkumab )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症2
96クローン病3
97潰瘍性大腸炎3

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2051200133
31/03/202112/02/2021A study of Guselkumab in Participants with Systemic SclerosisA Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants with Systemic Sclerosis Scleroderma, SystemicGroup 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.
Numaguchi HirotakaNULLNot Recruiting>= 18age old<= 75age oldBoth56Phase 2Japan
2NCT04683029
(ClinicalTrials.gov)
February 24, 202122/12/2020A Study of Guselkumab in Participants With Systemic SclerosisA Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic SclerosisScleroderma, SystemicDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: PlaceboJanssen Pharmaceutical K.K.NULLActive, not recruiting18 Years75 YearsAll56Phase 2Japan

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031210678
22/08/202218/03/2022A Study of Guselkumab Subcutaneous Therapy in Participants with Moderately to Severely Active Crohn's DiseaseA 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 DiseaseGuselkumab 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 NumaguchiNULLPending>= 18age oldNot applicableBoth318Phase 3Australia;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
2NCT05197049
(ClinicalTrials.gov)
January 19, 202217/1/2022A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's DiseaseA 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 DiseaseCrohn DiseaseDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll318Phase 3United 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
3NCT03466411
(ClinicalTrials.gov)
April 13, 20188/3/2018A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseA 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 DiseaseCrohn's DiseaseDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Guselkumab Dose 4;Drug: Guselkumab Dose 5;Drug: Guselkumab;Drug: Ustekinumab;Drug: PlaceboJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll1409Phase 2/Phase 3Latvia;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

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05528510
(ClinicalTrials.gov)
September 13, 202219/8/2022A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ColitisColitis, UlcerativeDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Other: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll400Phase 3United 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
2JPRN-JapicCTI-194980
22/5/202030/09/2019A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 Ulcerative ColitisIntervention 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.
Janssen Pharmaceutical K.K.NULLrecruiting18BOTH1000Phase 2-3Japan, Asia except Japan, North America, Europe
3NCT03662542
(ClinicalTrials.gov)
November 20, 20186/9/2018A Study of 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 ColitisColitis, UlcerativeDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: PlaceboJanssen Research & Development, LLCNULLCompleted18 Years65 YearsAll214Phase 2United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine