臨床研究等提出・公開システム

Date of registration	Dec. 15, 2025
Last modified on	April. 08, 2026
Trial ID	jRCT2041250143

Scientific Title	A PHASE IIb, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION STUDY WITH AN ACTIVE TREATMENT EXTENSION TO ASSESS THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF RO7837195 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
Public Title	A PHASE IIb, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION STUDY WITH AN ACTIVE TREATMENT EXTENSION TO ASSESS THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF RO7837195 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Contact for Scientific Queries	Name	jRCT Inquiry Receipt Center
	Affiliation	IQVIA Services Japan G.K.
	Address	Keikyu Dai-1 Building ,4-10-18 Takanawa, Minato-ku, Tokyo
	Telephone	+81-3-6859-9500
	E-mail	Koji.ikegami@iqvia.com
Contact for Public Queries	Name	jRCT Inquiry Receipt Center
	Affiliation	IQVIA Services Japan G.K.
	Address	Keikyu Dai-1 Building ,4-10-18 Takanawa, Minato-ku, Tokyo
	Telephone	+81-3-6859-9500
	E-mail	Koji.ikegami@iqvia.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 22, 2025
Actual date of first enrollment		Feb. 26, 2026
Target sample size		17
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	-Diagnosis of ulcerative colitis (UC) established at least 3 months -Moderately to severely active UC assessed by mMS -Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
	Exclusion Criteria	-Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC -Diagnosis of Crohn's disease or indeterminate colitis -Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a) -Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ulcerative Colitis
Intervention(s)		DRUG: RO7837195 DRUG: RO7837195 Matched Placebo
Primary Outcome(s)		Percentage of Participants With Clinical Remission at Week 12

Primary Sponsor	Genentech, Inc.

Name of Certified Review Board	National Hospital Organization Kanazawa Medical Center Institutional Review Board
Address	1-1 Shimoishibiki-machi, Kanazawa, Ishikawa
Telephone	+81-76-262-4161
E-Mail	302-kanazawaCR@mail.hosp.go.jp
Approval Status	Approval
Date of approval	Sept. 19, 2025

Plan to share IPD	Yes
Plan description	For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Secondary ID(s)	NCT06979336
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Brazil/Canada/China /Czech Republic/France/Germany/India/Italy/South Korea/Mexico/Poland/United Kingdom/United States

History of Changes

No	Publication date
2	April. 08, 2026	(this page)	Changes
1	Dec. 15, 2025	Detail

List of change history