Guselkum    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis15

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
15 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004002-25-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
950Phase 2;Phase 3Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium
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.NULLrecruiting18BOTH950Phase 2b;Phase 3Japan, Asia except Japan, North America, Europe
3EUCTR2018-004002-25-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
950Phase 2;Phase 3United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
4EUCTR2018-004002-25-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
950Phase 2;Phase 3United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
5EUCTR2018-004002-25-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]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 2;Phase 3Portugal;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-004002-25-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
7EUCTR2018-004002-25-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]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
950Phase 2;Phase 3United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
8EUCTR2018-004002-25-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]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 2;Phase 3United 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
9EUCTR2018-004002-25-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
950Phase 2;Phase 3United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
10EUCTR2018-004002-25-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 3United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-004002-25-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]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 2;Phase 3Portugal;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
12NCT04033445
(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, LLCNULLRecruiting18 YearsN/AAll950Phase 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;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania
13EUCTR2018-001510-15-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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany
14EUCTR2018-001510-15-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]
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
210Phase 2United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany
15NCT03662542
(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, LLCNULLRecruiting18 Years65 YearsAll210Phase 2United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine