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Study of Navenibart to prevent attacks in adults and adolescents with Hereditary Angioedema

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What is this trial about?

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

This study focuses on people with Hereditary Angioedema (HAE), a rare genetic condition that causes unexpected episodes of severe swelling in various parts of the body. The research evaluates a new medication called Navenibart (also known as STAR-0215), which is being tested to see if it can prevent HAE attacks from occurring.

The study compares Navenibart against placebo to determine how effective it is in reducing the frequency of HAE attacks. During the study, participants will receive either Navenibart or placebo as a subcutaneous (under the skin) injection. The treatment period lasts for 6 months, during which participants will be monitored for any HAE attacks and their severity.

Throughout the study, researchers will track how many HAE attacks occur and how severe they are. They will also monitor the overall well-being of participants and any changes in their quality of life. The medication will be tested in both adults and adolescents with HAE to evaluate its safety and effectiveness in preventing attacks.

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

    Initial period - Run-in phase

    Your hereditary angioedema (HAE) attacks will be monitored to establish your baseline attack frequency.

    You need to experience at least 2 HAE attacks during this period to continue in the study.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Navenibart or a matching placebo.

    Neither you nor your doctor will know which treatment you are receiving.

  3. Step 3

    Treatment period - 6 months

    You will receive subcutaneous injections (under the skin) of the study medication.

    Your HAE attacks will be monitored and confirmed by the study doctor.

    You may receive additional treatment if needed for any HAE attacks that occur.

    Your quality of life will be assessed using a questionnaire.

    Any side effects will be monitored and recorded.

  4. Step 4

    Evaluation points

    The study will track:

    - Number of HAE attacks during the 6-month period

    - Severity of attacks (moderate or severe)

    - Number of attacks requiring additional treatment

    - Time between receiving medication and first attack

    - Changes in your quality of life

    - Any side effects you may experience

  5. Step 5

    Study completion

    The treatment period ends after 6 months.

    Final assessments will be conducted to evaluate the medication's effectiveness and safety.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of Hereditary Angioedema (HAE) Type 1 or Type 2, supported by:
    • Medical history showing typical HAE symptoms
    • Laboratory test results confirming the condition
    • Must have experienced at least 2 HAE attacks during the initial observation period (Run-In period), which need to be verified by the study doctor
    • Can be either male or female
    • Must be an adolescent or adult (12 years and older)
    • Must be able to have their HAE attacks confirmed according to the study's specific definition
    • Must be willing to participate in the study's observation period before receiving treatment

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions to any medications
  • Active liver disease (problems with liver function)
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • Major surgery planned during the study period
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • History of blood clotting disorders (conditions that affect blood's ability to form clots)
  • Severe kidney problems (poor kidney function)
  • Active cancer or ongoing cancer treatment
  • History of drug or alcohol abuse within the past year
  • Severe mental health conditions that could affect participation
  • Taking medications that could interfere with the study drug
  • Unable to follow study procedures or attend scheduled visits
  • Any condition that, in the investigator's opinion, makes participation unsafe
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Investigated drugs

Navenibart is an investigational medication being studied for preventing attacks in people with Hereditary Angioedema (HAE). HAE is a rare genetic condition that causes sudden episodes of swelling in various parts of the body. This medication is being tested to see if it can reduce the frequency of these swelling attacks and help manage the condition in both adults and adolescents.

What is already known about the treatment

Navenibart - An investigational medication being studied in Phase 3 clinical trials for the prevention of Hereditary Angioedema (HAE) attacks in both adult and adolescent patients. This novel therapeutic agent is being evaluated through a multicenter, randomized, double-blind, placebo-controlled study known as ALPHA-ORBIT. While the specific mechanism of action and form of administration are not detailed in the source data, the medication is being tested as a preventive treatment for HAE, a rare genetic condition characterized by recurrent episodes of severe swelling in various parts of the body. The trial aims to demonstrate the superiority of navenibart over placebo in preventing HAE attacks while also assessing its safety and tolerability profile in the target patient population.

Investigated diseases

Hereditary Angioedema - A rare genetic condition that causes recurring episodes of severe swelling in various parts of the body. The swelling can affect the hands, feet, face, intestinal walls, and airways. Episodes of swelling develop over 24 hours and typically last for 2-3 days without treatment. The condition is caused by a deficiency or dysfunction of certain blood proteins that help regulate swelling. Between episodes, patients may have no visible symptoms. The frequency of attacks varies greatly among individuals, with some experiencing weekly episodes while others have them only occasionally.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521660-35-00Protocol codeSTAR-0215-301Estimated enrolment146 patientsSponsorAstria Therapeutics Inc.

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