LYC-30937 ( 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11

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
1EUCTR2016-003633-26-PL
(EUCTR)
23/03/201727/12/2016A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS 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 Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
2EUCTR2016-003633-26-CZ
(EUCTR)
10/03/201712/12/2016A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
3EUCTR2016-003633-26-NL
(EUCTR)
17/01/201724/10/2016A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
4EUCTR2016-003633-26-HU
(EUCTR)
23/12/201608/11/2016A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands
5EUCTR2016-000518-31-CZ
(EUCTR)
07/11/201630/08/2016A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS 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 Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
6NCT02764229
(ClinicalTrials.gov)
November 1, 20164/5/2016Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative ColitisA Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative ColitisColitis, UlcerativeDrug: LYC-30937-ECLycera Corp.NULLTerminated18 Years75 YearsAll112Phase 2United States;Czechia;Hungary;Netherlands;Poland;Serbia
7EUCTR2016-000518-31-PL
(EUCTR)
21/10/201619/08/2016A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS 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 Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
8EUCTR2016-000518-31-HU
(EUCTR)
05/10/201627/07/2016A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands
9EUCTR2016-000518-31-NL
(EUCTR)
16/08/201627/06/2016A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: LYC-30937-EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937
Lycera Corp.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
10NCT02762500
(ClinicalTrials.gov)
July 20163/5/2016An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative ColitisColitis, UlcerativeDrug: LYC-30937-EC;Drug: PlaceboLycera Corp.NULLCompleted18 Years75 YearsAll124Phase 2United States;Canada;Czechia;Hungary;Netherlands;Poland;Serbia;Czech Republic
11NCT02818543
(ClinicalTrials.gov)
March 201630/3/2016Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative ColitisAn Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: LYC-30937Lycera Corp.NULLCompleted18 Years75 YearsBoth6Phase 1Hungary