Study of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis

JRCT ID: jRCT2031230403

Registered date:16/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Moderately to Severely Active Ulcerative Colitis
• Date of first enrollment: 22/01/2024
• Target sample size: 176
• Countries of recruitment: US,Japan,Canada,Japan,Australia,Japan,South Korea,Japan,Austria,Japan,Berugium,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,Switzerland,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

GS-5290 600 mg: 2 GS-5290 300 mg tablets and 1 placebo-to-match (PTM)-1 tablet, orally once daily
GS-5290 300 mg: 1 GS-5290 300 mg tablet, 1 PTM-2 tablet, and 1 PTM-1 tablet, orally once daily
GS-5290 150 mg: 1 GS-5290 150 mg tablet and 2 PTM-2 tablets, orally once daily

Outcome(s)

• Primary Outcome: Clinical Response

Secondary Outcome

Clinical Remission
Endoscopic Response
Histologic Endoscopic Mucosal Improvement

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old

Include criteria

UC of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.

Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).

Previous treatment history of approved UC therapy with at least one of the following advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action:
a.TNFa inhibitor
b.IL-12/23 inhibitor
c.Leukocyte trafficking modulator
d.Janus kinase inhibitor

Exclude criteria

Current diagnosis of CD or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
Participants with disease limited to the rectum during screening endoscopy.
Participants who are pregnant, breastfeeding, intend to become pregnant, or are of childbearing potential
Known hypersensitivity to the study drug, its metabolites, or formulation excipient.

Related Information

• Primary Sponsor: Ueda Hiroki
• Secondary ID(s): NCT06029972