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A Study of Navenibart in Participants With Hereditary Angioedema

Study acronym: ALPHA-ORBIT
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv17 Show 4 more changesShow less
    • Primary completion moved earlier from Mar 2027 to Dec 2026
    • Study completion moved earlier from Sep 2027 to Jun 2027
    • Enrollment target: estimated 145 to confirmed 157
    • Study sites revised (86)
  2. Trial status changed: Recruiting → Enrolling by Invitation
    • Study sites: 87 to 86
    v16
  3. Study sites: 85 to 87v15
  4. Trial sites expanded: 79 → 85 locationsv14
  5. Study sites: 69 to 79v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 43 to 69v12
  2. Study sites: 29 to 43v11
  3. Study sites: 20 to 29
    • Eligibility criteria shortened, about 6 words
    v10
  4. Study sites: 14 to 20v9
  5. Study sites: 8 to 14v8
  6. Study sites: 6 to 8v7
  7. Study sites: 4 to 6
    • Start date changed from estimate of Mar 2025 to Mar 20, 2025
    v6
  8. Study sites revised (4)v5
  9. Study sites: 1 to 4v4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  11. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
Trial Details
NCT Number NCT06842823
Lead Sponsor Astria Therapeutics, Inc.
Conditions
(from sponsor)		 Hereditary Angioedema (HAE)
Related terms Angioedema, Angioedemas, Hereditary
Enrollment 157 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov