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

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects and safety of a treatment called BW-20805 Injection for adults with Hereditary Angioedema. Hereditary Angioedema is a rare genetic condition that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The treatment being tested, BW-20805, is a solution for injection that is administered under the skin.

The purpose of the study is to determine how well BW-20805 can prevent attacks of Hereditary Angioedema. Participants in the study will receive the BW-20805 Injection and will be monitored over a period of time to see if there is a reduction in the frequency of their swelling attacks. The study will also look at the safety of the treatment by observing any side effects that may occur during the trial.

Participants will be involved in the study for several months, during which they will receive regular injections and attend follow-up visits to track their progress. The study aims to provide valuable information on whether BW-20805 can be an effective and safe option for managing Hereditary Angioedema in adults.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This means you agree to participate and understand the study requirements.

    You must be between 18 and 70 years old and have a documented diagnosis of hereditary angioedema (HAE).

  2. Step 2

    Run-in period

    During the initial 8-week run-in period, you will need to experience at least two HAE attacks. These attacks will be confirmed by an investigator based on specific criteria.

    You should have access to and be able to use at least one acute medication for HAE attacks.

  3. Step 3

    Treatment phase

    You will receive the study medication, BW-20805 Injection, which is a solution for injection administered subcutaneously (under the skin).

    The main objective is to determine the effect of BW-20805 on reducing the rate of HAE attacks.

  4. Step 4

    Monitoring and assessments

    Throughout the study, you will be monitored for any changes in the frequency of HAE attacks. This will be measured from the start of the study to day 169.

    You will also be monitored for any side effects or adverse events during the study period.

  5. Step 5

    Extension period

    If applicable, you may enter an extension period where the effects of the medication will continue to be assessed.

    The study aims to observe changes in the monthly rate of HAE attacks and plasma PKK concentration during this time.

  6. Step 6

    Completion

    The study is expected to end by April 30, 2028. Your participation will contribute to understanding the efficacy and safety of BW-20805 in treating hereditary angioedema.

Who can join the trial?

6 criteria

  • Must have given written informed consent and be able to comply with all study requirements.
  • Males or females aged 18 to 70 years at the time of giving consent.
  • Must have a documented diagnosis of HAE-1 or HAE-2 (types of Hereditary Angioedema).
  • Must have experienced at least 2 attacks of Hereditary Angioedema within an 8-week period, confirmed by a study doctor.
  • Must have access to and be able to use at least one medication for sudden attacks.
  • Females who can have children and males with partners who can have children must follow specific birth control requirements.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with Hereditary Angioedema cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

BW-20805 is a medication being studied for its potential to help people with a condition called hereditary angioedema, which can cause sudden and severe swelling in different parts of the body. This medication is being tested to see if it can reduce the number of these swelling attacks. The study is looking at how well this medication works and how safe it is for people to use. By taking this medication, the hope is that patients will experience fewer attacks and have a better quality of life.

What is already known about the treatment

BW-20805 – This medication is administered to patients in a form that is not specified in the provided data, but it is used in a clinical trial setting. Currently, BW-20805 is being studied in a Phase 2 clinical trial to evaluate its effectiveness and safety for people with Hereditary Angioedema (HAE), a condition that causes sudden swelling attacks. The main goal of the trial is to see if BW-20805 can help reduce the frequency of these attacks. The medication works at the molecular level by targeting specific pathways involved in the swelling process, although the exact mechanism is not detailed in the data. It is classified pharmacologically as a treatment for hereditary angioedema, focusing on preventing the symptoms associated with this condition.

Investigated diseases

Hereditary Angioedema – Hereditary Angioedema is a genetic disorder characterized by recurrent episodes of severe swelling. This swelling can occur in various parts of the body, including the hands, feet, face, and airway. The condition is caused by a deficiency or dysfunction of a protein called C1 inhibitor, which leads to an overproduction of bradykinin, a peptide that increases blood vessel permeability. Swelling episodes can be triggered by stress, trauma, or hormonal changes, but they can also occur without any apparent cause. The swelling typically develops over several hours and can last for a few days. While the swelling itself is not painful, it can cause discomfort and, in some cases, lead to complications if it affects the airway or internal organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518207-22-00Protocol codeBW-20805-2001Estimated enrolment24 patientsSponsorShanghai Argo Biopharmaceutical Co. Ltd.

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