TEV-48574 ( DrugBank: - )


2 diseases
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4
97潰瘍性大腸炎4

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-002593-89-CZ
(EUCTR)
23/01/202328/12/2022A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability ofTEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study - RELIEVE UCCD LTE Moderate to severe Ulcerative colitis or moderate to severe Crohn'sdisease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TEV-48574
Product Code: TEV-48574
INN or Proposed INN: TEV-48574
Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A
Teva Branded Pharmaceutical Products R&D, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
128Phase 2United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Norway;Germany
2NCT05668013
(ClinicalTrials.gov)
January 11, 202312/12/2022A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA 24-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)Crohn Disease;Colitis, UlcerativeDrug: TEV-48574 Dose Regimen A;Drug: TEV-48574 Dose Regiment BTeva Branded Pharmaceutical Products R&D, Inc.NULLRecruiting18 Years75 YearsAll128Phase 2United States
3EUCTR2021-006881-19-CZ
(EUCTR)
06/01/202306/01/2023A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s DiseaseA 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) - RELIEVE UCCD Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TEV-48574
Product Code: TEV-48574
INN or Proposed INN: TEV-48574
Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A
Teva Branded Pharmaceutical Products R&D, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;Norway;Germany;Japan
4NCT05499130
(ClinicalTrials.gov)
August 29, 202211/8/2022A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)Crohn Disease;Colitis, UlcerativeDrug: TEV-48574;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLRecruiting18 Years75 YearsAll280Phase 2United States

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
1EUCTR2022-002593-89-CZ
(EUCTR)
23/01/202328/12/2022A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability ofTEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study - RELIEVE UCCD LTE Moderate to severe Ulcerative colitis or moderate to severe Crohn'sdisease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TEV-48574
Product Code: TEV-48574
INN or Proposed INN: TEV-48574
Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A
Teva Branded Pharmaceutical Products R&D, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
128Phase 2United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Norway;Germany
2NCT05668013
(ClinicalTrials.gov)
January 11, 202312/12/2022A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA 24-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)Crohn Disease;Colitis, UlcerativeDrug: TEV-48574 Dose Regimen A;Drug: TEV-48574 Dose Regiment BTeva Branded Pharmaceutical Products R&D, Inc.NULLRecruiting18 Years75 YearsAll128Phase 2United States
3EUCTR2021-006881-19-CZ
(EUCTR)
06/01/202306/01/2023A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s DiseaseA 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) - RELIEVE UCCD Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TEV-48574
Product Code: TEV-48574
INN or Proposed INN: TEV-48574
Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A
Teva Branded Pharmaceutical Products R&D, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;Norway;Germany;Japan
4NCT05499130
(ClinicalTrials.gov)
August 29, 202211/8/2022A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseaseA 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)Crohn Disease;Colitis, UlcerativeDrug: TEV-48574;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLRecruiting18 Years75 YearsAll280Phase 2United States