TNFa-Kinoid ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病8

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2010-019996-32-BG
(EUCTR)
27/04/201124/02/2011A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 Moderate to severe Crohn's Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
2EUCTR2010-019996-32-DE
(EUCTR)
31/03/201122/11/2010A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
3EUCTR2010-019996-32-HU
(EUCTR)
18/03/201131/01/2011A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 12.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2Hungary;Belgium;Bulgaria;Netherlands;Germany
4EUCTR2010-019996-32-CZ
(EUCTR)
11/02/201126/11/2010A phase II, randomized, double-blind, placebo-controlled study toevaluate the clinical efficacy, safety and immunogenicity ofNeovacs'TNFa-Kinoid in adult subjects with Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNFa-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany
5NCT01291810
(ClinicalTrials.gov)
February 201117/12/2010Clinical Efficacy of TNFa Kinoid in Crohn's Disease PatientsA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's DiseaseCrohn's DiseaseBiological: TNF Kinoid;Biological: WFINeovacsNULLCompleted18 Years65 YearsBoth66Phase 2Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania
6EUCTR2010-019996-32-BE
(EUCTR)
12/01/201104/10/2010A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease Crohn’s Disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany
7NCT00808262
(ClinicalTrials.gov)
October 200812/12/2008Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's DiseaseA Phase I/II, Open-label, Escalating Dose, Optimal Two-stage, Study of TNFa-Kinoid (TNF- K) Immunization in Crohn's Disease PatientsCrohn's DiseaseBiological: TNFa KinoidNeovacsNULLCompleted18 Years65 YearsBoth21Phase 1/Phase 2South Africa;Switzerland
8EUCTR2010-019996-32-NL
(EUCTR)
27/07/2011A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective and safe for treating adult subjects with moderate to severe Crohn's DiseaseA phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’ TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 Moderate to severe Crohn’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Neovacs SANULLNot RecruitingFemale: yes
Male: yes
132Phase 2France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Germany;Netherlands