GB004 ( 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2

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
1EUCTR2020-002306-12-PL
(EUCTR)
12/01/202108/09/2020GB004 in adult subjects with active ulcerative colitisA Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate GB004 in adult subjects with mild-to-moderate active ulcerative colitis Mild-to-moderate active ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GB004
INN or Proposed INN: Not applicable
Other descriptive name: GB004-HCl
Product Code: GB004
INN or Proposed INN: Not applicable
Other descriptive name: GB004-HCl
GB004, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2United States;Serbia;Belarus;Poland;Ukraine;Romania;Australia;Russian Federation;Georgia;Italy;Moldova, Republic of;Korea, Republic of
2NCT03860896
(ClinicalTrials.gov)
April 24, 201914/2/2019GB004 in Adult Subjects With Active Ulcerative ColitisA Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: GB004;Drug: PlaceboGB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.NULLCompleted18 Years74 YearsAll34Phase 1United States;Georgia;Moldova, Republic of