臨床研究等提出・公開システム

Scientific Title	A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants with Alopecia Areata
Public Title	Efficacy and Safety of Deucravacitinib in Adults with Alopecia Areata (IM011-134)

Contact for Scientific Queries	Name	Fuentes Duculan David
	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	Fuentes Duculan David
	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	Not Recruiting

Anticipated date of first enrollment		Feb. 06, 2023
Actual date of first enrollment
Target sample size		9
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	Documented clinical diagnosis of AA for at least 6 months Alopecia Areata Investigator Global Assessment ( AA-IGA) grade >- 3
	Exclusion Criteria	Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score History or evidence of active infection and/or febrile illness Any ongoing treatment known to affect hair growth
	Age Minimum	18age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Alopecia Areata
Intervention(s)		Arm A: deucravacitinib Arm B: deucravacitinib Arm C: Placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		SALT score safety and tolerability
Secondary Outcome(s)		SALT score

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokyo Medical University Hospital IRB
Address	6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Telephone	+81-3-3342-6111
E-Mail	adm_crsc@tokyo-med.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05556265
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Canada/France/Germany/Poland/USA

History of Changes

No	Publication date
2	July. 14, 2023	(this page)	Changes
1	Feb. 06, 2023	Detail

List of change history