臨床研究等提出・公開システム

Japanese

Date of registration	June. 18, 2022
Last modified on	Dec. 10, 2024
Trial ID	jRCT2021220013

Scientific Title	A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy
Public Title	A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis (IM047-001)

Contact for Scientific Queries	Name	Liu W. Jerry
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Liu W. Jerry
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 01, 2022
Actual date of first enrollment
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	dose comparison control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit - Evidence of UC extending beyond the rectum, as determined by baseline endoscopy - Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
	Exclusion Criteria	- Diagnosis of Crohn's disease or indeterminate colitis - Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool - Apheresis within 2 weeks of randomization - History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
	Age Minimum	2age old over
	Age Maximum	17age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ulcerative Colitis (UC)
Intervention(s)		Ozanimod High Dose Ozanimod Low Dose
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Proportion of participants who achieve clinical remission [ Time Frame: At Week 52 ]
Secondary Outcome(s)		Proportion of participants who achieve clinical remission [ Time Frame: At Week 10 ] Proportion of participants who achieve clinical response [ Time Frame: At Week 52 ] Proportion of participants who achieve clinical response [ Time Frame: At Week 10 ] Proportion of participants who achieve symptomatic remission [ Time Frame: At Week 10 and Week 52 ] Time to achievement of symptomatic remission [ Time Frame: Up to 6 years ] Proportion of participants who achieve endoscopic improvement [ Time Frame: At Week 10 and Week 52 ] Proportion of participants who achieve corticosteroid free remission [ Time Frame: At Week 52 ] Incidence of Adverse Events (AEs) [ Time Frame: Up to 6 years ] Incidence of Serious Adverse Events [ Time Frame: Up to 6 years ] Incidence of AEs leading to discontinuation from treatment [ Time Frame: Up to 6 years ] Incidence of AEs of interest [ Time Frame: Up to 6 years ] Steady state systemic exposure of ozanimod and CC112273 [ Time Frame: At Week 18 and throughout the study, up to 70 weeks ] Absolute change from baseline in Absolute Lymphocyte Count (ALC) [ Time Frame: Up to 6 years ] Percent change from baseline in ALC [ Time Frame: Up to 6 years ]

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kurume University IRB
Address	67 Asahi-machi Kurume-shi, Fukushima
Telephone	+81-942-31-7200
E-Mail	kcrc_jimu@kurume-u.ac.jp
Approval Status	Approval
Date of approval	May. 16, 2022

Name of Certified Review Board	Institutional Review Board, Institute of Science Tokyo Hospital
Address	1-5-45 Yushima, Bunkyo-ku, Fukushima
Telephone	+81-3-3813-6111
E-Mail	mkan-rinsho.adm@tmd.ac.jp
Approval Status	Approval
Date of approval	May. 16, 2022

Name of Certified Review Board	Osaka Medical and Pharmaceutical University Hospital Institutional Review Board
Address	Daigaku-machi Takatsuki-city, Fukushima
Telephone	+81-72-683-1221
E-Mail	ompu_irb@ompu.ac.jp
Approval Status	Approval
Date of approval	May. 16, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05076175
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	France/United States

History of Changes

No	Publication date
4	Dec. 10, 2024	(this page)	Changes
3	Sept. 23, 2022	Detail	Changes
2	July. 05, 2022	Detail	Changes
1	June. 18, 2022	Detail

List of change history