臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 06, 2023
Last modified on	Dec. 09, 2023
Trial ID	jRCT2031230330

Scientific Title	A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBA )
Public Title	A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (I6T-MC-AMBA)

Contact for Scientific Queries	Name	Masaki Takeshi
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com
Contact for Public Queries	Name	Trial Guide Call Center
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 15, 2023
Actual date of first enrollment		Nov. 22, 2023
Target sample size		60
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Males or females weighing >10 kg and >=2 and <18 years old Have moderate to severe UC Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report
	Exclusion Criteria	Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis Have immune deficiency syndrome Previous bowel resection or intestinal surgery Evidence of toxic megacolon History or current evidence of cancer of the gastrointestinal tract
	Age Minimum	2age old over
	Age Maximum	17age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ulcerative Colitis
Intervention(s)		-Drug: Mirikizumab IV Administered IV Other Name: LY3074828 -Drug: Mirikizumab SC Administered SC Other Name: LY3074828 Study Arms -Experimental: Mirikizumab Weight-Based Group 1 Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). Interventions: Drug: Mirikizumab IV Drug: Mirikizumab SC -Experimental: Mirikizumab Weight-Based Group 2 Experimental: Participants will receive mirikizumab weight-based dosing IV or SC. Interventions: Drug: Mirikizumab IV Drug: Mirikizumab SC -Experimental: Mirikizumab Weight-Based Group 3 Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. Interventions: Drug: Mirikizumab IV Drug: Mirikizumab SC
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders [ Time Frame: Baseline to Week 52 ]
Secondary Outcome(s)

Primary Sponsor	Eli Lilly Japan K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hayashi Diabetes Clinic Institutional Review Board
Address	Abeasa Medical 2F, 3-2 Shineicho, Chigasaki City, Kanagawa, Kanagawa
Telephone	+81-42-648-5551
E-Mail	htonyou-irb@eps.co.jp
Approval Status	Approval
Date of approval	June. 21, 2023

Plan to share IPD	Yes
Plan description	Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Secondary ID(s)	NCT05784246
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	Australia/Belgium/Canada/France/Germany/Italy/Poland/Portugal/United States

History of Changes

No	Publication date
3	Dec. 09, 2023	(this page)	Changes
2	Nov. 11, 2023	Detail	Changes
1	Sept. 06, 2023	Detail

List of change history