臨床研究等提出・公開システム

Date of registration	Dec. 26, 2024
Last modified on	April. 10, 2026
Trial ID	jRCT2031240584

Scientific Title	A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjogren's Disease
Public Title	A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjogren's Syndrome (PSjD)

Contact for Scientific Queries	Name	Asahi Yo
	Affiliation	IQVIA Services Japan G.K.
	Address	Keikyudaiichi building 4-10-18 Takanawa, Minato-ku, Tokyo
	Telephone	+81-3-6859-9500
	E-mail	JP-ARGX-113-2306_CL@iqvia.com
Contact for Public Queries	Name	IQVIA Services Japan G.K. jRCT Inquiries IQVIA Contact
	Affiliation	IQVIA Services Japan G.K.
	Address	Keikyudaiichi building 4-10-18 Takanawa, Minato-ku, Tokyo
	Telephone	+81-3-6859-9500
	E-mail	JP-ARGX-113-2306_CL@iqvia.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 26, 2024
Target sample size		30
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	-Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. -Meets the following criteria at screening: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI >= 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (>= 0.01 mL/min)
	Exclusion Criteria	-Secondary Sjogren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis. diverticular disease associated with colitis, or microscopic colitis. -Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening. -Any severe systemic PSjD manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion. -Use of <= 24 weeks prior to screening -Anti-CD20 or anti-CD19 antibody received < 6 months before screening
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Primary Sjogren's Disease
Intervention(s)		Eligible patients will be randomized (1:1 ratio) to receive either of efgartigimod PH20 SC or matching placebo in a double-blind fashion for 48 weeks. Participants completing the double-blinded treatment period will receive open-label efgartigimod PH20 SC.
Primary Outcome(s)		Change from baseline in clinESSDAI at week 48

Primary Sponsor	argenx BV

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	National Hospital Organization Tokyo Medical Center Institutional Review Board
Address	2-5-1,Higashigaoka,Meguro-ku,Tokyo, Tokyo
Telephone	+81-3-3411-0111
Approval Status	Approval
Date of approval	Jan. 31, 2025

Plan to share IPD	No

Secondary ID(s)	NCT06684847
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	U.S./EU/Asian countries /(about 38 countries)

History of Changes

No	Publication date
4	April. 10, 2026	(this page)	Changes
3	Oct. 14, 2025	Detail	Changes
2	Feb. 12, 2025	Detail	Changes
1	Dec. 26, 2024	Detail

List of change history