臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 16, 2023
Last modified on	July. 09, 2024
Trial ID	jRCT2031230403

Scientific Title	A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)
Public Title	Study of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)

Contact for Scientific Queries	Name	Ueda Hiroki
	Affiliation	Gilead Sciences
	Address	Gran Tokyo South Tower, 1-9-2, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5539-1946
	E-mail	JPClinicalOperations@gilead.com
Contact for Public Queries	Name	Sakai Mayu
	Affiliation	Gilead Sciences
	Address	Gran Tokyo South Tower, 1-9-2, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5539-1946
	E-mail	JPClinicalOperations@gilead.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 22, 2024
Actual date of first enrollment
Target sample size		176
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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.
	Age Minimum	18age old over
	Age Maximum	75age old not
	Gender
Health Condition(s) or Problem(s) Studied		Moderately to Severely Active Ulcerative Colitis
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
Health Condition(s) Keyword		Ulcerative Colitis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Clinical Response
Secondary Outcome(s)		Clinical Remission Endoscopic Response Histologic Endoscopic Mucosal Improvement

Primary Sponsor	Gilead Sciences

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The IRB of Kitasato University Shirokane Campus
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Tokyo
Telephone
E-Mail
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06029972
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	US/Canada/Australia/South Korea/Austria/Berugium/France/Germany/Hungary/Italy/Poland/Switzerland/UK

History of Changes

No	Publication date
4	July. 09, 2024	(this page)	Changes
3	Mar. 28, 2024	Detail	Changes
2	Oct. 19, 2023	Detail	Changes
1	Oct. 16, 2023	Detail

List of change history