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

NCT07204938 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Hereditary Angioedema (HAE)

Interventions

DRUG

navenibart

Navenibart will be administered as a subcutaneous injection.

Sponsors & Collaborators

  • Astria Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2031-06-30
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204938 on ClinicalTrials.gov