臨床研究等提出・公開システム

Date of registration	June. 12, 2026
Last modified on	June. 12, 2026
Trial ID	jRCT2071260041

Scientific Title	A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema (ORBIT-EXPANSE)
Public Title	A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema (ORBIT-EXPANSE)

Contact for Scientific Queries	Name	Dyson Rie
	Affiliation	Fortrea Japan K.K.
	Address	Harumi Triton Square Office Tower Y 8F, 1-8-11, Harumi, Chuo-ku, Tokyo
	Telephone	+81-90-5202-7413
	E-mail	rie.dyson@fortrea.com
Contact for Public Queries	Name	Dyson Rie
	Affiliation	Fortrea Japan K.K.
	Address	Harumi Triton Square Office Tower Y 8F, 1-8-11, Harumi, Chuo-ku, Tokyo
	Telephone	+81-90-5202-7413
	E-mail	rie.dyson@fortrea.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 12, 2026
Target sample size		11
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Participants from STAR-0215-301 who met one of the following conditions: a. Completed STAR-0215-301 through the Day 181 visit b. Withdrew from STAR-0215-301 but met the following criteria: i. Received 2 doses of IP ii. completed >= 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator
	Exclusion Criteria	1. Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent 2. Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening. 3. Known sensitivity to the ingredients in the formulation of IP
	Age Minimum	12age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hereditary Angioedema
Intervention(s)		Navenibart(STAR-0215) 600 mg SC every 3 months every 3 months (Q3M), 300 mg SC Q3M or 600 mg SC every 6 months (Q6M).
Primary Outcome(s)		Incidence of treatment-emergent adverse events (TEAEs)

Primary Sponsor	Astria Therapeutics, Inc.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Kurume University Hospital
Address	67, Asahimachi, Kurume-shi, Fukuoka
Telephone	+81-942-35-3311
Approval Status	Approval
Date of approval	Jan. 22, 2026

Plan to share IPD	No

Secondary ID(s)	NCT07204938
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Austria/Brazil/Bulgaria/Canada/Czech Republic/France/Germany/Hong Kong/Hungary/Israel/Italy/Macedonia/Netherlands/New Zealand/Poland/Portugal/South Africa/South Korea/Spain/United Kingdom/United States