臨床研究等提出・公開システム

Date of registration	June. 08, 2023
Last modified on	June. 08, 2023
Trial ID	jRCT2041230033

Scientific Title	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis (GEMINI1)
Public Title	Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (GEMINI1)

Contact for Scientific Queries	Name	Randazzo Bruce
	Affiliation	AnaptysBio, Inc.
	Address	10770 Wateridge Circle, Suite 210 San Diego, CA 92121 USA
	Telephone	1-858-362-6295
	E-mail	clinicaltrialinfo@anaptysbio.com
Contact for Public Queries	Name	Rosario Chikako
	Affiliation	Parexel International Inc.
	Address	Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo
	Telephone	+81-80-8929-3137
	E-mail	Clinicaltrial-registration@parexel.com

Recruitment status	Pending

Anticipated date of first enrollment		June. 22, 2023
Target sample size		7
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	Subject has a BSA affected with pustules (excluding palms and soles) >= 5%, a GPPPGA score >= 3 (moderate severity), and a PRS score >= 3 (moderate severity) at Day 1
	Exclusion Criteria	- Subject has other form of psoriasis excluding psoriasis vulgaris - Subject flare is so severe that patient's life is at risk
	Age Minimum	18age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Generalized Pustular Psoriasis
Intervention(s)		On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive a single intravenous (IV) high dose imsidolimab, low dose imsidolimab, or placebo.
Primary Outcome(s)		Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear) at Week 4
Secondary Outcome(s)		Proportion of subjects achieving a PRS score of 0 (clear) or 1 (almost clear) at Week 1

Primary Sponsor	AnaptysBio, Inc.

Secondary Sponsor

Name of Certified Review Board	Review board for contract research on drug
Address	2-174 Edobashi, Tsu, Mie, Japan, Mie
Telephone	+81-59-231-5246

Plan to share IPD	No

Secondary ID(s)	NCT05352893
Issuing Authority	ClinicalTrials.gov

Secondary ID(s)	2021-001447-27
Issuing Authority	EudraCT

Countries of Recruitment（Except Japan）	US/Australia/Morocco/Georgia/Germany/Korea/Malaysia/Poland/Romania/Slovakia/Spain/Thailand/Tunisia/Turkey/China