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BW-20805

BW-20805 is currently being studied as a potential treatment for Hereditary Angioedema (HAE), a rare genetic condition that causes sudden episodes of swelling in various parts of the body. This Phase 2, open-label, multicenter clinical trial aims to evaluate the efficacy and safety of BW-20805 in adult patients with HAE. The study explores different dosing schedules and amounts of the drug administered through subcutaneous (under the skin) injections. Researchers are particularly interested in measuring how well BW-20805 works in reducing the frequency of HAE attacks and assessing its safety profile over an extended treatment period.

Table of Contents

What is BW-20805?

BW-20805 is an investigational medication being studied for the prevention of attacks in people with Hereditary Angioedema (HAE). This drug is currently in Phase 2 clinical trials, which means it is still being tested to determine its effectiveness and safety before it can be approved for general use by patients[1]. The drug is being developed as a prophylactic treatment, which means it’s designed to prevent HAE attacks from occurring rather than treating them once they’ve already started.

Understanding Hereditary Angioedema (HAE)

Hereditary Angioedema is a rare genetic disorder that causes episodes of severe swelling (edema) in various body parts, including the hands, feet, face, airway, and intestinal tract. These swelling attacks can be painful, disfiguring, and even life-threatening if they affect the airway. HAE is typically caused by a deficiency or dysfunction of a blood protein called C1 inhibitor, which normally helps regulate several complex processes in the blood[1].

Unlike allergic reactions, HAE attacks do not respond to antihistamines, epinephrine, or corticosteroids. The unpredictable nature of HAE attacks can significantly impact a person’s quality of life, making preventive treatments particularly valuable for patients.

Current Clinical Trial

BW-20805 is being evaluated in “A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects With Hereditary Angioedema.”[1] This means:

  • Phase 2: The drug has passed initial safety testing in humans (Phase 1) and is now being tested in a larger group of people with HAE to see if it works and to further evaluate its safety.
  • Open-label: Both the researchers and participants know which treatment is being administered (as opposed to a blinded study where participants don’t know if they’re receiving the actual drug or a placebo).
  • Multicenter: The study is being conducted at multiple clinical sites, likely across different regions or countries.
  • Adult Subjects: The study is enrolling adult patients diagnosed with HAE.

Dosing Regimens Under Investigation

The clinical trial is evaluating three different dosing regimens of BW-20805[1]:

  1. 600 mg every 24 weeks: This group receives a 600 mg dose of BW-20805 administered subcutaneously (under the skin) every 24 weeks from Day 1 to Day 673 of the study.
  2. 300 mg every 24 weeks: This group receives a 300 mg dose of BW-20805 administered subcutaneously every 24 weeks from Day 1 to Day 169, and then from Day 337 to Day 673.
  3. 300 mg every 12 weeks: This group receives a 300 mg dose of BW-20805 administered subcutaneously more frequently – every 12 weeks from Day 1 to Day 589.

By testing different doses and administration schedules, researchers aim to determine which regimen provides the best balance of effectiveness and convenience for patients with HAE.

Effectiveness Measurements

The primary goal of the study is to determine how well BW-20805 works at preventing HAE attacks. Specifically, researchers are measuring the “change in time-normalized monthly (per 4 weeks) HAE attack rate from baseline to Day 169.”[1] This means they’re comparing:

  • How many HAE attacks a participant experienced in a typical month before starting the treatment (baseline)
  • How many HAE attacks the same participant experiences per month during the first 169 days of treatment

A significant reduction in the frequency of attacks would suggest that BW-20805 is effective as a preventive treatment for HAE.

Safety Monitoring

An important secondary goal of the study is to evaluate the safety and tolerability of BW-20805. Researchers are tracking the “incidence and severity of SAEs and AEs up to 96 weeks” across the main study period, extension study period, and the whole study[1].

In this context:

  • SAEs refers to Serious Adverse Events – any medical occurrences that result in death, are life-threatening, require hospitalization, cause persistent or significant disability, or birth defects.
  • AEs refers to Adverse Events – any unfavorable and unintended sign, symptom, or disease that occurs while a person is in the clinical trial, whether or not it’s related to the treatment being studied.

This extensive safety monitoring is crucial for determining whether BW-20805 can be safely used by patients with HAE in the long term.

Administration Method

BW-20805 is administered as a subcutaneous (SC) injection[1]. This means the medication is injected just under the skin, rather than into a muscle (intramuscular) or vein (intravenous). Subcutaneous injections are generally less painful than other injection types and can often be self-administered by patients after proper training, which would be convenient for a long-term preventive treatment.

The long intervals between doses (either 12 or 24 weeks, depending on the study group) suggest that if approved, BW-20805 might offer patients with HAE a convenient dosing schedule that requires infrequent administration while still providing continuous protection against HAE attacks.

Study Aspect Details
Trial Type Phase 2, open-label, multicenter study
Medication BW-20805
Condition Hereditary Angioedema (HAE)
Treatment Groups – BW-20805 600 mg every 24 weeks
– BW-20805 300 mg every 24 weeks
– BW-20805 300 mg every 12 weeks
Administration Method Subcutaneous (SC) injection
Primary Outcome Change in monthly HAE attack rate from baseline to Day 169
Secondary Outcome Safety and tolerability assessment through monitoring adverse events for up to 96 weeks
Study Duration Up to 673 days (approximately 96 weeks)

FAQ

  • What is BW-20805 and how is it being studied? BW-20805 is an investigational drug being tested for the treatment of Hereditary Angioedema (HAE). It's currently in Phase 2 clinical trials, where researchers are studying its effectiveness and safety when given as a subcutaneous (under the skin) injection. The study is exploring different doses (300mg and 600mg) and different dosing schedules (every 12 weeks or every 24 weeks) to determine the optimal treatment approach.
  • What are the main goals of this clinical trial? The primary goal of this trial is to determine how effectively BW-20805 prevents HAE attacks by measuring the change in monthly attack rates from the beginning of the study to Day 169. Another key goal is to evaluate the safety and tolerability of multiple doses of BW-20805 by tracking any side effects or serious adverse events that might occur during the 96-week study period.
  • How long does the clinical trial last? The clinical trial has an extensive follow-up period, with the longest treatment arm lasting up to 673 days (approximately 96 weeks or nearly 2 years). Different dosing groups have different treatment durations, with some participants receiving treatment for about 589 days, while others may receive treatment for the full 673 days.
  • What different treatment groups are being studied in this trial? The trial is studying three different treatment approaches: one group receives BW-20805 at 600 mg every 24 weeks, a second group receives 300 mg every 24 weeks, and a third group receives 300 mg every 12 weeks. These different dosing regimens help researchers determine the most effective dose and frequency for preventing HAE attacks.
  • How will researchers know if BW-20805 is working? Researchers will primarily measure the effectiveness of BW-20805 by calculating the change in how often participants experience HAE attacks. They'll compare the number of attacks participants had before starting the treatment (baseline) to how many they have during the treatment period, specifically looking at the monthly attack rate up to Day 169. They'll also closely monitor any side effects or adverse events throughout the entire study to ensure the drug is safe.

Ongoing Clinical Trials on BW-20805

  • Study on the Effect and Safety of BW-20805 for Adults with Hereditary Angioedema

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Poland Spain

Glossary

  • Hereditary Angioedema (HAE): A rare genetic disorder characterized by recurrent episodes of severe swelling (edema) in various body parts, including the hands, feet, face, airway, and intestinal walls. These attacks can be painful, disfiguring, and even life-threatening if they affect the airway.
  • Phase 2 Clinical Trial: The second stage of testing a new drug in humans, which focuses on how well the drug works for a specific medical condition, determines the correct dosage, and continues to evaluate safety in a larger group of participants.
  • Open-label Study: A type of clinical trial where both researchers and participants know which treatment is being administered, unlike a blinded study where this information is concealed.
  • Multicenter Study: A clinical trial conducted at more than one medical or research institution, which helps to ensure that findings apply to a broader population.
  • Subcutaneous (SC) Administration: A method of giving medication by injecting it under the skin, which allows for slower absorption than intravenous injections.
  • Prophylactic Effect: The preventive action of a treatment. In this trial, it refers to how well BW-20805 prevents HAE attacks from occurring.
  • Time-normalized Monthly Attack Rate: A standardized measurement that calculates how many HAE attacks occur in a 4-week period, allowing for consistent comparison across different time periods.
  • Baseline: The initial measurement or observation taken before treatment begins, which serves as a reference point for comparing subsequent measurements.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that develops during treatment, whether or not it is considered related to the medication being studied.
  • Serious Adverse Events (SAEs): Adverse events that result in hospitalization, disability, birth defects, life-threatening conditions, or death.
  • Q12W: Medical shorthand meaning 'every 12 weeks,' describing how often a medication is administered.
  • Q24W: Medical shorthand meaning 'every 24 weeks,' describing how often a medication is administered.

References

  1. https://clinicaltrials.gov/study/NCT06846398