Clinical Trials List
2024-04-12 - 2028-12-31
Phase II
Recruiting8
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51.911
Ulcerative colitis, unspecified with rectal bleeding
ICD-10K51.912
Ulcerative colitis, unspecified with intestinal obstruction
ICD-10K51.913
Ulcerative colitis, unspecified with fistula
ICD-10K51.914
Ulcerative colitis, unspecified with abscess
ICD-10K51.918
Ulcerative colitis, unspecified with other complication
ICD-10K51.919
Ulcerative colitis, unspecified with unspecified complications
ICD-9556.9
Ulcerative colitis, unspecified
A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
GILEAD SCIENCES HONG KONG LIMITED, TAIWAN BRANCH
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/28
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Huey-Ling Chen 無
- 吳嘉峯 無
- CHIEN-CHIH TUNG 無
- YEN-HSUAN NI 無
- 謝銘鈞 無
- 翁孟慈 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hung-Hsin Lin 無
- Chun-Chi Lin 無
- 張天恩 無
- 王彥博 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳宜樺 無
- Tsung-Yu Tsai 無
- Chun-Lung Feng 無
- 黃柏儒 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Fang-Jung Yu Yu 無
- Huang-Ming Hu 無
- 張哲墉 無
- 王俊偉 無
- I-CHEN WU 無
- Wen-Hung Hsu 無
- 王崧維 無
- 吳政毅 無
- Chao-Hung Kuo 無
- Wang Yao-Kuang 無
- Chien-Yu Lu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1.
Inclution Criteria
• Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
• Individuals have UC with minimum disease extent of 15 cm from the anal verge.
• Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
• Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.
• Individuals have an inadequate response or loss of response or are intolerant to < 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)
Exclusion Criteria
•Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis.
•Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
•Have any history of exposure to vedolizumab or other integrin antagonists
•Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply
The Estimated Number of Participants
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Taiwan
16 participants
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Global
423 participants
