Evaluating navenibart for treating hereditary angioedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Site 9
  Birmingham, Alabama, United States Recruiting
• Site 2
  Scottsdale, Arizona, United States Recruiting
• Site 3
  Little Rock, Arkansas, United States Recruiting
• Site 26
  San Diego, California, United States Recruiting
• Site 14
  San Diego, California, United States Recruiting
• Site 4
  Santa Monica, California, United States Recruiting

+37 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Claire VanEenwyk, MD
• Email: alphaorbit_general@astriatx.com
• Phone: 1-617-349-1971

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Takhzyro use in teenagers and adults with hereditary angioedema in South Korea

  This study looks at how safe and useful Takhzyro is when used in real-world care for teenagers and adults with hereditary angioedema in South Korea.

  Recruiting at 3 sites Takeda · Suwon, Gyeonggi-do and 2 other locations · NCT07445087

• Long-term treatment with ADX-324 for people with hereditary angioedema

  This extension will try additional doses of ADX-324 (onvuzosiran) to see if continuing the drug is safe and helps people with Type I or II hereditary angioedema who finished the earlier Phase 3 trial.

  Recruiting at 3 sites Phase 3 ADARx Pharmaceuticals, Inc. · Litchfield Park, Arizona and 47 other locations · NCT07428499

• Donidalorsen for children with hereditary angioedema

  This trial tests if donidalorsen is safe and how it is processed in the body for children aged 2 to under 12 with hereditary angioedema types I or II.

  Recruiting at 18 sites Phase 3 Ionis Pharmaceuticals, Inc. · Santa Monica, California and 17 other locations · NCT07298447

• C1-Inhibitor Function Test to Diagnose HAE in Algeria

  A test that measures C1-inhibitor function is being tried to see if it can accurately diagnose hereditary angioedema in patients in Algeria.

  Recruiting Takeda · Algiers · NCT07293364

• Oral deucrictibant to prevent and treat hereditary angioedema attacks

  This trial tests whether daily oral deucrictibant XR can prevent angioedema attacks and whether deucrictibant capsules can quickly relieve acute attacks in adults with bradykinin-mediated hereditary angioedema.

  Recruiting Phase 1/2 Institute for Asthma and Allergy · Wheaton, Maryland · NCT07046806

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.