Lusvertikimab ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎3

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
1EUCTR2020-001398-59-BE
(EUCTR)
15/12/202013/10/2020Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) Moderate to severe 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: OSE-127
Product Code: OSE-127
INN or Proposed INN: Lusvertikimab
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127
OSE ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Serbia;Belarus;Hungary;Poland;Belgium;Ukraine;Lithuania;Croatia;Russian Federation;Georgia;Bulgaria;Latvia
2EUCTR2020-001398-59-HR
(EUCTR)
02/12/202007/12/2020Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) Moderate to severe 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: OSE-127
Product Code: OSE-127
INN or Proposed INN: Lusvertikimab
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127
OSE ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Belgium;Poland;Croatia;Georgia;South Africa;Bulgaria;Latvia
3EUCTR2020-001398-59-BG
(EUCTR)
13/10/202018/09/2020Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) Moderate to severe 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: OSE-127
Product Code: OSE-127
INN or Proposed INN: Lusvertikimab
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127
OSE ImmunotherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Poland;Belgium;Croatia;Bulgaria;South Africa;Georgia;Latvia