臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 14, 2022
Last modified on	Dec. 19, 2023
Trial ID	jRCT2061210069

Scientific Title	A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects with Moderate to Severe Psoriasis
Public Title	A Study to Assess Adverse Events and Disease Activity with Cedirogant (ABBV-157) in Adult Participants with Moderate to Severe Psoriasis

Contact for Scientific Queries	Name	Yamazaki Hayato
	Affiliation	AbbVie G.K.
	Address	3-1-21 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com
Contact for Public Queries	Name	Contact for Patients and HCP
	Affiliation	AbbVie G.K.
	Address	3-1-21 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com

Recruitment status	Suspended

Anticipated date of first enrollment		Jan. 31, 2022
Actual date of first enrollment		April. 01, 2022
Target sample size		200
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	Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
	Exclusion Criteria	- Primary non-responders to previous anti-IL-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis. - Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
	Age Minimum	18age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Psoriasis
Intervention(s)		The subject will receive cedirogant or placebo.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percentage of participants achieving >=75% reduction from baseline in Psoriasis Area Severity Index (PASI) score (PASI 75) at week16.
Secondary Outcome(s)		Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16

Primary Sponsor	AbbVie G.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Okayama University Hospital Institutional Review Board
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Telephone	+81-86-223-7151
E-Mail
Approval Status	Approval
Date of approval	Jan. 11, 2022

Secondary ID(s)	NCT05044234
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	United States/Canada

History of Changes

No	Publication date
4	Dec. 19, 2023	(this page)	Changes
3	Dec. 26, 2022	Detail	Changes
2	May. 19, 2022	Detail	Changes
1	Jan. 14, 2022	Detail

List of change history