LYS006 ( 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5

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_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2019-003113-34-SK
(EUCTR)
29/06/202127/04/2021Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitisA randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany
2EUCTR2019-003113-34-NO
(EUCTR)
04/05/202021/01/2020Ulcerative colitisA randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;Czechia;Hungary;Slovakia;Poland;Russian Federation;Bulgaria;Germany;Norway
3EUCTR2019-003113-34-HU
(EUCTR)
25/02/202009/01/2020Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitisA randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Russian Federation;Hungary;Norway;United States;Poland;Slovakia;Bulgaria;Germany
4EUCTR2019-003113-34-DE
(EUCTR)
19/02/202008/11/2019Ulcerative colitisA randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Norway;Germany
5NCT04074590
(ClinicalTrials.gov)
February 3, 202029/8/2019Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative ColitisA Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: LYS006;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll23Phase 2Bulgaria;Czechia;Germany;Poland;Russian Federation;Slovakia;Hungary;Norway;United Kingdom;United States