Guselkum ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎23

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
1EUCTR2021-005528-39-NL
(EUCTR)
14/12/202212/09/2022Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 2Portugal;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
2JPRN-jRCT2031220308
01/11/202201/09/2022A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative ColitisA 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 Colitis, UlcerativeGuselkumab
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 KazukoNULLPending>= 18age old<= 65age oldBoth550Phase 2Argentina;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
3NCT05242484
(ClinicalTrials.gov)
September 19, 202215/2/2022A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA 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 ColitisColitis, UlcerativeBiological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 Years65 YearsAll550Phase 2United 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
4NCT05528510
(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
5EUCTR2018-004002-25-SK
(EUCTR)
28/05/202113/01/2021A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3Serbia;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
6EUCTR2018-004002-25-LV
(EUCTR)
27/05/202102/02/2021A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 2;Phase 3Portugal;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
7EUCTR2018-004002-25-AT
(EUCTR)
12/05/202121/12/2020A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3Japan;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
8EUCTR2018-004002-25-NL
(EUCTR)
06/07/202017/09/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3Portugal;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
9JPRN-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
10EUCTR2018-004002-25-BG
(EUCTR)
13/05/202024/02/2020A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United 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
11EUCTR2018-004002-25-DE
(EUCTR)
07/04/202023/08/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United States;Portugal;Taiwan;Hong Kong;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
12EUCTR2018-004002-25-ES
(EUCTR)
28/02/202004/09/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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: guselkum
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
13EUCTR2018-004002-25-PT
(EUCTR)
03/02/202006/08/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 2;Phase 3Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
14EUCTR2018-004002-25-IT
(EUCTR)
24/10/201917/06/2021A Study of the Efficacy and Safety 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 - QUASAR 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]
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.4 Solution for infusion in pre-filled syringe
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.4 Solution for infusion in pre-filled syringe
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: Guselkumab
Other descriptive name: * D.3.4 Solution for injection/infusion in pre-filled syringe
Product Name: GUSELKUMAB
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.4 Solution for injection in pre-filled syringe
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
15EUCTR2018-004002-25-BE
(EUCTR)
21/10/201910/09/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3New Zealand;Japan;Sweden;Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;France;Jordan;Malaysia;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany
16EUCTR2018-004002-25-SE
(EUCTR)
15/10/201903/07/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 2;Phase 3United States;Portugal;Taiwan;Hong Kong;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
17EUCTR2018-004002-25-FR
(EUCTR)
15/10/201914/08/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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: guselkum
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
18EUCTR2018-004002-25-GB
(EUCTR)
09/10/201920/08/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
950Phase 2;Phase 3Russian Federation;United States;Portugal;Netherlands;Sweden;Austria;Latvia;China;Brazil;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Turkey;Belgium;Taiwan;Italy;Israel;Australia;Germany
19EUCTR2018-004002-25-HU
(EUCTR)
01/10/201913/08/2019A Study of the Efficacy and Safety 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 - QUASAR 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]
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 NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
20NCT04033445
(ClinicalTrials.gov)
September 26, 201924/7/2019A 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 ColitisUlcerative ColitisDrug: Placebo;Drug: GuselkumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll1064Phase 2/Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania
21EUCTR2018-001510-15-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
22EUCTR2018-001510-15-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
23NCT03662542
(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