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A study of navenibart for long-term safety in patients with hereditary angioedema

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves Hereditary Angioedema, which is a rare inherited condition that causes episodes of swelling in different parts of the body, including the hands, feet, face, intestinal tract, and airways. These swelling episodes, called attacks, can be painful and potentially dangerous, especially when they affect the throat or abdomen. The treatment being tested is called Navenibart, also known by its code name STAR-0215. This medication is designed to work against a specific protein in the blood called plasma kallikrein, which plays a role in causing the swelling attacks. Some participants will receive Navenibart while others will receive placebo. The medication is given as an injection under the skin.

The purpose of this study is to assess the long-term safety and tolerability of Navenibart in people with Hereditary Angioedema. The study will also look at how well the medication works in preventing swelling attacks over an extended period of time. Participants in this study will be people who previously took part in another study called STAR-0215-301 and either completed that study or received at least two doses of the medication and were followed for at least two months after the second dose.

During the study, participants will receive regular doses of the medication, with a maximum daily dose of 600 milligrams and a total maximum dose of 9600 milligrams over a treatment period of up to 48 weeks. The study will track any side effects or health problems that occur during treatment. Researchers will also count how many swelling attacks participants experience, including how many are moderate or severe, and how many require emergency treatment. The study will measure whether participants have fewer attacks compared to before treatment, including whether they achieve reductions of 50 percent, 70 percent, or 90 percent in their attack rate, or whether they have no attacks at all. Quality of life will be measured using a questionnaire specifically designed for people with swelling conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Entry into the long-term extension study

    This study is designed as an extension of a previous clinical trial called STAR-0215-301.

    Your participation in this extension study is possible if you completed the previous trial through the Day 181 visit, or if you withdrew early but received at least 2 doses of the study medication and completed at least 2 months of follow-up after the second dose.

  2. Step 2

    Treatment with navenibart or placebo

    During the study, you will receive either navenibart or a matching placebo. A placebo is an inactive substance that looks like the study medication but contains no active ingredient.

    The medication will be administered as an injection under the skin, which is called subcutaneous administration.

    The study will evaluate the long-term safety and effectiveness of navenibart in treating hereditary angioedema, a condition characterized by episodes of swelling in various parts of the body.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, your health will be monitored to assess any side effects that may occur during treatment. This includes tracking any new symptoms or health changes that develop after starting the study medication.

    The number and severity of your angioedema attacks will be recorded. These attacks refer to episodes of swelling that are characteristic of your condition.

    Specific attention will be given to tracking moderate or severe attacks, attacks that require treatment with on-demand medication, and the time until your first attack after receiving the study medication.

    Your quality of life will be assessed using a questionnaire called the Angioedema Quality of Life questionnaire, which evaluates how your condition affects your daily activities and well-being.

  4. Step 4

    Evaluation of treatment response

    The study will measure whether you experience a reduction in the number of monthly angioedema attacks compared to before treatment.

    Response to treatment will be defined as achieving a reduction of 50%, 70%, or 90% in the rate of attacks.

    The study will also track whether you have no attacks at all during certain periods of the trial.

  5. Step 5

    Long-term follow-up

    This is a long-term study designed to assess the safety and effectiveness of the medication over an extended period.

    The study is expected to continue until approximately June 2031, allowing for comprehensive evaluation of the treatment's long-term effects.

    Throughout this period, your participation will involve continued monitoring and regular assessments as determined by the study protocol.

Who can join the trial?

4 criteria

  • You must have participated in the previous clinical trial called STAR-0215-301, which is the earlier study that tested the same medication
  • You must have completed the previous trial all the way through the Day 181 visit, which means you stayed in the study until day 181, OR
  • If you left the previous trial early, you can still join this study if you meet all of these conditions: you received 2 doses of the study medication, which means you got the treatment twice; you stayed in the trial for at least 2 months after receiving the second dose; and the study doctor believes you meet the other requirements to participate
  • The study doctor must confirm that you are suitable to take part in this long-term safety study

Who cannot join the trial?

7 criteria

  • The study does not list specific reasons that would prevent you from participating in this trial
  • Your doctor will review your complete medical history and current health condition to determine if this study is right for you
  • General factors that may affect your ability to join include other medical conditions you may have, medications you are currently taking, and your overall health status
  • If you are a woman who is pregnant (expecting a baby) or breastfeeding (nursing a baby), this may affect your ability to participate
  • If you have severe problems with your liver (the organ that cleans your blood) or kidneys (the organs that filter waste from your blood), you may not be able to join
  • If you have had serious allergic reactions (bad reactions where your body fights against a substance) to similar medications in the past, this may prevent you from participating
  • If you are currently participating in another clinical trial or have recently finished one, this may affect your eligibility
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Investigated drugs

  • Navenibart

    is an investigational medication being studied for the long-term treatment of hereditary angioedema, a rare genetic condition that causes episodes of severe swelling in various parts of the body. This medication is designed to help prevent these swelling attacks from occurring and to assess how safe it is when used over an extended period of time.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in clinical trials to help researchers compare the effects of the actual medication against no treatment, allowing them to determine if the medication being tested truly works.

What is already known about the treatment

Navenibart – Navenibart is an investigational medication currently being studied in clinical trials for the prevention of attacks in patients with hereditary angioedema, a rare genetic condition that causes sudden swelling in various parts of the body. The medication is being evaluated in a Phase 3 trial called ORBIT-EXPANSE to determine its long-term safety and effectiveness when used over extended periods. While the exact form of administration has not been specified in the available data, the drug works by targeting specific molecular pathways involved in controlling swelling episodes. As an experimental treatment, navenibart is not yet approved for general medical use and is only available to patients participating in authorized clinical research studies.

Investigated diseases

Hereditary Angioedema – Hereditary angioedema is a rare genetic disorder that causes episodes of swelling in various parts of the body. The swelling most commonly affects the skin, digestive system, and airways. These episodes, called attacks, can occur without warning or may be triggered by stress, illness, or minor injuries. The swelling develops because the body lacks sufficient amounts of a specific protein that helps control inflammation. Attacks can last from several hours to several days before the swelling gradually decreases. The frequency and severity of attacks varies greatly between individuals, with some experiencing episodes weekly while others have them less often.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521142-22-00Protocol codeSTAR-0215-302Estimated enrolment146 patientsSponsorAstria Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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