Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07204938 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 28 → 40 locationsv5
  2. Trial sites expanded: 10 → 28 locationsv4
  3. Study sites: 1 to 10v3
  4. Start date changed from estimate of Oct 2025 to Oct 1, 2025
    • Secondary endpoints: details revised at 1 of 8 entries
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07204938
Lead Sponsor Astria Therapeutics, Inc.
Conditions
(from sponsor)		 Hereditary Angioedema (HAE)
Related terms Angioedema, Angioedemas, Hereditary
Enrollment 145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov