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Clinical Trials List

Protocol NumberGS-US-409-5704

NCT Number(ClinicalTrials.gov Identfier)NCT06290934

Active

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 Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Trial Applicant

GILEAD SCIENCES HONG KONG LIMITED
Sponsor

GILEAD SCIENCES HONG KONG LIMITED, TAIWAN BRANCH
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 顏旭亨無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

許斯淵無
陳家昌無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator SHU-CHEN WEI 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王鴻源無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jiing-Chyuan Luo 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Wei Chou 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Deng-Chyang Wu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Tang Chiu

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Chia-Jung Kuo 無
Puo-Hsien Le Digestive System Department
Cheng-Yu Lin 無
許振銘無

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Moderately to Severely Active Ulcerative Colitis

Objectives

Primary Outcome Measures Proportion of Participants Achieving Clinical Response at Week 12 Secondary Outcome Measures Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths. Incidence of Treatment-emergent Lab Abnormalities Proportion of Participants Achieving Clinical Remission at Week 12 Proportion of Participants Achieving Clinical Remission at Week 52 Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12 Proportion of Participants Achieving Mucosal Healing at Week 12 Proportion of Participants Achieving Endoscopic Improvement at Week 12 To Assess the Efficacy of GS-1427 in Achieving Partial Modified Mayo Clinic Score (mMCS) remission at Week 76

Test Drug

GS-1427

Active Ingredient

GS-1427

Dosage Form

tablets

Dosage

75 mg

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

Key Inclusion 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

Key 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

Taiwan

16 participants
Global

228 participants