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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.05.2025
Italy	Not recruiting	31.05.2025
Poland	Not recruiting	31.05.2025
Spain	Not recruiting	31.05.2025

Trial locations

Investigated drugs:

BW-20805

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.

Investigated diseases:

Hereditary angioedema

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 ID:

2024-518207-22-00

Protocol code:

BW-20805-2001

Trial Phase:

Therapeutic exploratory (Phase II)

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

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