A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

Not Applicable

• Conditions: Hereditary Angioedema (HAE)
• Interventions: Drug: navenibart

• Registration Number: NCT07204938
• Lead Sponsor: Astria Therapeutics, Inc.

Brief Summary

This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-30
• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2031-06
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Participants from STAR-0215-301 who met one of the following conditions:

1. Completed STAR-0215-301 through the Day 181 visit
2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult Dosing Regimen 1	navenibart	Participants will receive 600 mg of navenibart every 3 months.
Adult Dosing Regimen 2	navenibart	Participants will receive 300 mg of navenibart every 3 months.
Adult Dosing Regimen 3	navenibart	Participants will receive 600 mg of navenibart every 6 months.
Adolescent Dosing Regimen 1	navenibart	Participants will receive 300 mg of navenibart every 3 months.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	Day 1 through Month 48

Secondary Outcome Measures

Name	Time	Method
Number of time-normalized investigator-confirmed HAE attacks	Day 1 through Month 48
Number of moderate or severe investigator-confirmed HAE attacks	Day 1 through Month 48
Number of investigator-confirmed HAE attacks that require on-demand treatment	Day 1 through Month 48
Percent reduction in monthly investigator-confirmed HAE attacks	Day 1 through Month 48
Time to first investigator-confirmed HAE attack after first dose	Day 1 through Month 48
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction in investigator-confirmed HAE attack rate	Day 1 through Month 48
Number of participants with no investigator-confirmed HAE attacks	Day 1 through Month 48
Angioedema Quality of Life questionnaire total score	Day 1 through Month 48

Trial Locations

Locations (1)

Site 2; 🇺🇸 Scottsdale, Arizona, United States