96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215

  
59 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1NCT02974322
(ClinicalTrials.gov)
December 1, 201723/11/2016A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's DiseaseCrohn DiseaseDrug: GED-0301;Drug: PlaceboCelgeneNULLWithdrawn12 YearsN/AAll0Phase 3United States;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic
2EUCTR2015-001924-40-HR
(EUCTR)
13/10/201702/11/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
3EUCTR2015-001924-40-PT
(EUCTR)
26/06/201701/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
4EUCTR2015-001924-40-BE
(EUCTR)
14/06/201706/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Netherlands;Latvia;Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark
5EUCTR2015-001924-40-IT
(EUCTR)
12/06/201723/02/2018A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Other descriptive name: GED-0301
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Other descriptive name: GED-0301
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
6EUCTR2015-001924-40-GB
(EUCTR)
17/05/201727/01/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
7EUCTR2015-001924-40-GR
(EUCTR)
05/05/201720/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
8EUCTR2015-001924-40-NL
(EUCTR)
24/04/201708/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
9EUCTR2015-001924-40-FR
(EUCTR)
20/04/201727/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
10EUCTR2015-001924-40-DE
(EUCTR)
12/04/201706/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
11EUCTR2015-001924-40-ES
(EUCTR)
07/04/201710/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
12EUCTR2015-001924-40-HU
(EUCTR)
07/04/201709/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden
13EUCTR2015-001924-40-DK
(EUCTR)
04/04/201707/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
14EUCTR2015-001924-40-LV
(EUCTR)
31/03/201702/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
15EUCTR2015-001924-40-FI
(EUCTR)
30/03/201728/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
16EUCTR2015-001963-37-FI
(EUCTR)
30/03/201723/02/2017A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
17EUCTR2015-001924-40-CZ
(EUCTR)
21/03/201701/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden
18EUCTR2015-001924-40-SK
(EUCTR)
16/03/201703/02/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
798 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden
19EUCTR2015-001924-40-AT
(EUCTR)
21/02/201718/01/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden
20EUCTR2015-001925-18-FI
(EUCTR)
25/01/201722/12/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
21EUCTR2015-001963-37-GR
(EUCTR)
28/09/201601/06/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
22NCT02641392
(ClinicalTrials.gov)
July 25, 201623/12/2015A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's DiseaseA Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: GED-0301;Other: PlaceboCelgeneNULLTerminated12 YearsN/AAll310Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Estonia;Finland;Malaysia;New Zealand;South Africa
23EUCTR2015-001963-37-BG
(EUCTR)
23/06/201613/04/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
24EUCTR2015-001925-18-GR
(EUCTR)
01/06/201606/04/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3France;Australia;Denmark;Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
25EUCTR2015-001925-18-HR
(EUCTR)
09/05/201606/07/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
1064 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
26EUCTR2015-001963-37-HR
(EUCTR)
05/05/201621/06/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
1414 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Serbia;United States;Taiwan;Estonia;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Hungary;United Kingdom;Austria;Turkey;Finland;Bosnia and Herzegovina;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia
27EUCTR2015-001963-37-BE
(EUCTR)
03/05/201610/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
28EUCTR2015-001925-18-BG
(EUCTR)
20/04/201618/03/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
29EUCTR2015-001963-37-DK
(EUCTR)
15/04/201622/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Sweden;Norway;Germany;New Zealand;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria
30EUCTR2015-001963-37-SK
(EUCTR)
14/04/201607/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
31EUCTR2015-001925-18-SK
(EUCTR)
14/04/201630/11/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
32EUCTR2015-001963-37-ES
(EUCTR)
08/04/201603/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn?s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn?s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
33NCT02685683
(ClinicalTrials.gov)
April 4, 201615/2/2016Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's DiseaseA Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: GED-0301CelgeneNULLTerminated18 YearsN/AAll18Phase 2Italy
34EUCTR2015-001925-18-CZ
(EUCTR)
01/04/201622/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
35EUCTR2015-001963-37-CZ
(EUCTR)
01/04/201622/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn's disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
36EUCTR2015-001963-37-PT
(EUCTR)
28/03/201610/02/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
37EUCTR2015-001925-18-PT
(EUCTR)
28/03/201610/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
38EUCTR2015-001925-18-BE
(EUCTR)
25/03/201620/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Serbia;Portugal;United States;Estonia
39EUCTR2015-001963-37-IT
(EUCTR)
23/03/201623/02/2018A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: Mongersen
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
40EUCTR2015-001963-37-GB
(EUCTR)
15/03/201629/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;United States;Serbia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Pakistan;Finland;Oman;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
41EUCTR2015-001925-18-ES
(EUCTR)
07/03/201604/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn?s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
42EUCTR2015-001925-18-DK
(EUCTR)
04/03/201606/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
43EUCTR2015-001963-37-DE
(EUCTR)
26/02/201611/01/2016A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
44EUCTR2015-001925-18-GB
(EUCTR)
24/02/201618/11/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety o Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
45EUCTR2015-001925-18-LV
(EUCTR)
18/02/201601/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
46EUCTR2015-001963-37-LV
(EUCTR)
18/02/201601/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
47EUCTR2015-001925-18-HU
(EUCTR)
15/02/201617/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
48EUCTR2015-001963-37-HU
(EUCTR)
15/02/201617/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
49EUCTR2015-001963-37-SE
(EUCTR)
10/02/201617/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
50EUCTR2015-001925-18-DE
(EUCTR)
09/02/201607/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
51EUCTR2015-001693-18-IT
(EUCTR)
29/01/201607/03/2018-A Phase 2, Open-Label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects with Active Crohn's Disease - GED-0301-CD-005 Active Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
INN or Proposed INN: Mongersen
Other descriptive name: GED-0301
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
16Phase 2Italy
52EUCTR2015-001963-37-AT
(EUCTR)
29/01/201622/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
53EUCTR2015-001925-18-AT
(EUCTR)
29/01/201622/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
54EUCTR2015-001925-18-SE
(EUCTR)
27/01/201625/11/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
55EUCTR2015-001925-18-EE
(EUCTR)
29/12/201507/12/2015A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
56EUCTR2015-001963-37-EE
(EUCTR)
29/12/201507/12/2015A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1414Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
57NCT02596893
(ClinicalTrials.gov)
December 8, 20153/11/2015Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's DiseaseCrohn DiseaseDrug: GED-0301;Drug: PlaceboCelgeneNULLTerminated18 YearsN/AAll701Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Former Serbia and Montenegro;South Africa
58EUCTR2015-001925-18-NO
(EUCTR)
27/01/2016A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s diseaseA Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease Active Crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
1064Phase 3United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
59EUCTR2015-001924-40-PL
(EUCTR)
29/03/2017A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease Active Crohn's disease
MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Product Name: Mongersen
Product Code: GED-0301
INN or Proposed INN: mongersen
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
798Phase 3Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden