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NAVENIBART

NAVENIBART is an investigational drug currently being evaluated in clinical trials for the prevention of attacks in people with Hereditary Angioedema (HAE). This rare genetic condition causes episodes of severe swelling in various parts of the body. A Phase 3 clinical trial is currently assessing different dosing regimens of NAVENIBART given as subcutaneous injections to determine its safety and effectiveness compared to placebo. The study aims to evaluate how well NAVENIBART reduces the frequency of HAE attacks and improves quality of life for both adult and adolescent participants with type 1 or type 2 HAE.

Table of Contents

What is Navenibart?

Navenibart (also known as STAR-0215) is an investigational medication being studied for the prevention of attacks in people with Hereditary Angioedema (HAE). It is currently being evaluated in a Phase 3 clinical trial to determine its safety and effectiveness compared to placebo[1]. This medication is designed to help prevent HAE attacks rather than treat them after they begin.

Understanding Hereditary Angioedema (HAE)

Hereditary Angioedema is a rare genetic condition that causes episodes of severe swelling in various parts of the body. These swelling attacks can affect the hands, feet, face, genitals, airway, or intestinal tract. HAE attacks can be painful, disfiguring, and in cases where the airway is affected, potentially life-threatening. The condition is typically categorized as Type 1 or Type 2 HAE, both of which are being studied in the Navenibart clinical trial[1].

How is Navenibart Administered?

Navenibart is administered as a subcutaneous injection, which means it is injected under the skin[1]. This administration method allows patients to potentially receive the medication outside of a medical facility, though the current study is examining the drug in a controlled clinical setting.

Dosing Regimens Being Studied

The current clinical trial is testing several different dosing schedules to determine which might be most effective[1]:

  • Dosing Regimen 1 for Adults: 600 mg of navenibart every 3 months
  • Dosing Regimen 2 for Adults: 600 mg of navenibart on Day 1, followed by 300 mg every 3 months starting at month 3
  • Dosing Regimen 3 for Adults: 600 mg of navenibart every 6 months
  • Regimen for Adolescents: 600 mg of navenibart on Day 1, followed by 300 mg every 3 months starting at month 3

Some adult participants in the study will receive a placebo instead of navenibart to help researchers accurately measure the drug’s effectiveness[1].

Current Clinical Research

Navenibart is being studied in a Phase 3 clinical trial, which is typically one of the final stages of testing before a medication might be approved for general use. This particular study is described as multicenter (conducted at multiple medical facilities), randomized (participants are assigned to treatment groups by chance), double-blind (neither participants nor researchers know who is receiving the actual drug versus placebo), and placebo-controlled (comparing the drug to an inactive substance)[1].

The study includes both adult and adolescent participants with type 1 or type 2 HAE. Adult participants are randomly assigned to one of four treatment groups, while adolescent participants all receive the same navenibart regimen[1].

How Effectiveness is Being Measured

Researchers are measuring several outcomes to determine if navenibart is effective[1]:

  1. Primary outcome: The number of HAE attacks during the 6-month treatment period. These attacks are confirmed by investigators and normalized for time.
  2. Secondary outcomes include:
    • Number of moderate or severe HAE attacks
    • Number of HAE attacks requiring on-demand treatment
    • Percent reduction in monthly HAE attacks compared to the pre-treatment period
    • Time until the first HAE attack after receiving doses
    • Number of participants who have a significant reduction (50%, 70%, or 90%) in HAE attacks
    • Number of participants with no HAE attacks during treatment

These measurements will help determine how well navenibart prevents HAE attacks and whether certain dosing regimens are more effective than others[1].

Safety Monitoring

As with any clinical trial, the safety of navenibart is being closely monitored. Researchers are tracking treatment-emergent adverse events, which are any unfavorable or unintended signs, symptoms, or diseases that occur during the study period. This monitoring will continue for nearly a full year (through day 361) to identify any potential side effects or safety concerns[1].

Impact on Quality of Life

Beyond just preventing attacks, researchers are also interested in how navenibart might improve patients’ overall quality of life. The study is using the Angioedema Quality of Life questionnaire, a specialized survey designed to measure how HAE affects a person’s daily life and well-being. Changes in scores on this questionnaire from the beginning to the end of the study will help determine if navenibart improves patients’ quality of life[1].

Study Aspect Details
Drug Name NAVENIBART (also known as STAR-0215)
Study Type Phase 3, multicenter, randomized, double-blind, placebo-controlled trial
Condition Hereditary Angioedema (HAE) Types 1 and 2
Administration Subcutaneous injection
Adult Dosing Regimens • 600 mg every 3 months
• 600 mg initial dose followed by 300 mg every 3 months
• 600 mg every 6 months
• Placebo every 3 months (control group)
Adolescent Dosing 600 mg initial dose followed by 300 mg every 3 months
Primary Outcome Number of HAE attacks during the 6-month treatment period
Key Secondary Outcomes • Reduction in moderate/severe attacks
• Reduction in attacks requiring on-demand treatment
• Percent reduction in monthly attacks
• Time to first attack
• Number of participants with significant attack reduction
• Participants with no attacks
• Quality of life improvements
Safety Assessment Monitoring of treatment-emergent adverse events for approximately one year

FAQ

  • What is NAVENIBART and how is it administered? NAVENIBART (also known as STAR-0215) is an investigational drug being studied for preventing HAE attacks. In the clinical trial, it's administered as a subcutaneous injection (an injection under the skin) at different dosing schedules depending on the study group.
  • What dosing regimens are being studied in the clinical trial? The trial is evaluating several dosing regimens: 600 mg every 3 months, 600 mg initially followed by 300 mg every 3 months, and 600 mg every 6 months for adults. Adolescents receive 600 mg initially followed by 300 mg every 3 months. These are compared against a placebo group.
  • How long does the clinical trial last? The main treatment period of the trial lasts for 6 months (181 days), during which the effectiveness of NAVENIBART is evaluated. However, safety monitoring continues for approximately one year (361 days) to fully assess the drug's safety profile.
  • How is the effectiveness of NAVENIBART being measured? The main measure of effectiveness is the reduction in the number of HAE attacks during the 6-month treatment period. Researchers are also looking at reduction in moderate or severe attacks, attacks requiring on-demand treatment, percentage of patients with significant reductions in attacks, and improvements in quality of life.
  • Who is eligible to participate in this clinical trial? The trial includes both adult and adolescent participants diagnosed with type 1 or type 2 Hereditary Angioedema (HAE). Adults are randomized to one of four treatment groups, while adolescents are assigned to a specific experimental group with its own dosing regimen.

Ongoing Clinical Trials on NAVENIBART

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

    Recruiting

    1 1
    Investigated drugs:
    Austria Bulgaria Czechia France Germany Hungary +5

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

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Czechia France Germany Hungary +5

  • Study on the Long-Term Safety of STAR-0215 for Adults with Hereditary Angioedema

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Poland

Glossary

  • Hereditary Angioedema (HAE): A rare genetic disorder characterized by recurrent episodes of severe swelling in various parts of the body, including the limbs, face, intestinal tract, and airway. These attacks can be painful, disabling, and potentially life-threatening.
  • Phase 3 clinical trial: A large-scale study conducted to confirm the effectiveness, monitor side effects, and compare to commonly used treatments. Phase 3 trials involve hundreds to thousands of participants and are typically the last phase before seeking regulatory approval.
  • Subcutaneous injection: An injection administered beneath the skin into the subcutaneous tissue (the layer of tissue between the skin and muscle). This method allows for slower absorption of medication compared to intravenous administration.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active ingredient. It's used as a comparison to determine if the actual drug has a real effect.
  • Randomized: A process like flipping a coin that assigns participants to different treatment groups by chance, reducing bias in how participants are allocated to each group.
  • Double-blind: A study design where neither the participants nor the researchers know which treatment (active drug or placebo) each participant is receiving until after the study is completed.
  • Placebo-controlled: A study design that uses a comparison group receiving a placebo to determine whether changes observed in the treatment group are due to the study drug or other factors.
  • Run-In Period: An initial period before the main treatment phase of a study when baseline measurements are taken to understand each participant's typical HAE attack frequency.
  • On-demand treatment: Medications used to treat an HAE attack after it has started, as opposed to preventive treatments that aim to reduce attack frequency.
  • Investigator-confirmed HAE attacks: HAE attacks that have been verified by the study doctors as true HAE attacks rather than symptoms that might resemble HAE but have other causes.
  • Angioedema Quality of Life questionnaire: A standardized set of questions designed to measure how HAE affects a person's quality of life, including physical comfort, ability to perform daily activities, and emotional well-being.
  • Treatment-emergent adverse events: Side effects or unwanted events that occur after starting the study medication and weren't present before, which may or may not be related to the treatment.

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