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Evaluating navenibart for treating hereditary angioedema

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)

Phase 3 Interventional Astria Therapeutics, Inc. · NCT06842823

This study is testing if a new treatment called navenibart can help adults and teens with hereditary angioedema have fewer attacks compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment145 (estimated)
Ages12 Years and up
SexAll
SponsorAstria Therapeutics, Inc. Industry-sponsored
Drugs / interventionsLanadelumab, Garadacimab
Locations87 sites (Birmingham, Alabama and 86 other locations)
Trial IDNCT06842823 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled evaluation of navenibart, administered subcutaneously, in adults and adolescents with type 1 or type 2 hereditary angioedema (HAE). The study aims to assess the safety and efficacy of navenibart in preventing HAE attacks compared to a placebo. Participants must have a documented diagnosis of HAE and have experienced at least two attacks during a specified run-in period. The trial will help determine if navenibart can effectively reduce the frequency of HAE attacks.

Who should consider this trial

Good fit: Ideal candidates are adults and adolescents diagnosed with type 1 or type 2 hereditary angioedema who have experienced multiple attacks.

Not a fit: Patients with other forms of chronic angioedema or those currently using certain preventive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of HAE attacks, improving patients' quality of life.

How similar studies have performed: Other studies have shown promise in treating hereditary angioedema with similar approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Documented diagnosis of HAE (Type 1 or 2). The following must be met:

  1. Documented clinical history consistent with HAE
  2. Lab findings consistent with HAE Type 1 or 2
* Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion Criteria:

* Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
* Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).

  1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
  2. Plasma-derived C1INH for LTP within 14 days prior to Run-In
  3. Berotralstat within 21 days prior to Run-In
  4. Lanadelumab within 70 days prior to Run-In
  5. Garadacimab within 90 days prior to Run-In

Where this trial is running

Birmingham, Alabama and 86 other locations

+37 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hereditary AngioedemaHAEAngioedema
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.