Hereditary Angioedema (HAE)Phase 2HAENCT06846398
A Phase 2 in Adult Subjects With Hereditary Angioedema
A Phase 2 study testing BW-20805 in people with Hereditary Angioedema (HAE), run by Shanghai Argo Biopharmaceutical Co., Ltd. at 18 sites in 6 countries.
Trial summary
A Phase 2 in Adult Subjects with Hereditary Angioedema Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- BW-20805
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 28 Feb 2025to 30 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent and be able to comply with all study requirements.
- Males or females 18 to 70 years of age at the time of informed consent.
- Documented diagnosis of HAE-1/HAE-2.
- At least 2 HAE attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition
- Access to and ability to use ≥ 1 acute medication(s)
- Female subjects must be non-pregnant;non-lactating, and either surgically sterile
- Male subjects with WOCBP partners, dual contraception is required if no surgically sterile
Who cannot join
- Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
- History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Have undergone major surgery within 3 months prior to screening.
- History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk
- History of allergic reaction to an oligonucleotide or N-acetylgalactosamine
Show all 12Show fewer
- Prior treatment with any oligonucleotides within 6 months if single dose or 12 months if multiple doses prior to screening.
- Exposure to another investigational drug or biological agent within 30 days or within at least 5 half-lives prior to screening.
- With ANY of the abnormalities in clinical laboratory tests at screening and run-in period
- Clinically significant findings on 12-lead electrocardiogram that would place the patient at risk or interfere with participation in the study at screening.
- Positive for Human immunodeficiency virus (HIV), HBsAg, Hepatitis C or syphilis infection
- Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to dosing.
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
China6 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
West China Hospital, Sichuan University
Chengdu, Sichaun, 610041
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 130030
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
United States5 sites
Duke University Medicine Center
Durham, North Carolina, 27705
Inova Clinical Trials and Research Center
Falls Church, Virginia, 22031
Penn State Milton S. Hershey MC - Penn State
Hershey, Pennsylvania, 17033
Institute for Asthma and Allergy - Wheaton
Silver Spring, Maryland, 20902
Washington University School of Medicine
St Louis, Missouri, 63141
Italy3 sites
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
Catania, Catania, 95125
Azienda Ospedaliero-Universitaria Careggi
Florence, Florence, 50134
Azienda Ospedale - Universita di Padova
Padova, PD, 35128
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 12200
Universitätsmedizin der Johannes Gutenberg
Mainz, Rhineland-Palatinate, 55101
Poland1 site
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-066
About this study
Official title: A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects With Hereditary Angioedema
A Phase 2 in Adult Subjects with Hereditary Angioedema
Read the detailed description
A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- BW-20805
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BW-20805Drug
SC administrations of BW-20805 600 mg on Day1 to Day673
BW-20805Drug
SC administrations of BW-20805 300 mg every 24 weeks on Day1 to Day169;Day337 to Day673
BW-20805Drug
SC administrations of BW-20805 300 mg every 12 weeks on Day 1 to Day 589
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BW-20805 600 mg Q24W*2 Receives: Drug: BW-20805 |
| Cohort 2 | Experimental | BW-20805 300 mg Q24W*2 Receives: Drug: BW-20805 |
| Cohort 3 | Experimental | BW-20805 300 mg Q12W*2 Receives: Drug: BW-20805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prophylactic effect of in HAE attack rate.
Change in time-normalized monthly (per 4 weeks) HAE attack rate from baseline to Day169
Measured: from baseline to Day169
Secondary outcomes (1)
To evaluate the safety and tolerability of multiple doses of BW-20805.
Incidence and severity of SAEs and AEs up to 96 weeks ( the main study period, extension study period and whole study)
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start28 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Magerl, Doctor, Principal investigator, Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846398
- Sponsor's protocol ID
- BW-20805-2001
- Acronym
- HAE
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects With Hereditary Angioedema
- ClinicalTrials.gov ID
- NCT06846398
- Acronym / sponsor ID
- HAE / BW-20805-2001
- Conditions
- Hereditary Angioedema (HAE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 in Adult Subjects with Hereditary Angioedema
Detailed description
A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BW-20805BW-20805 600 mg Q24W*2 |
| Cohort 2 | Experimental | Drug: BW-20805BW-20805 300 mg Q24W*2 |
| Cohort 3 | Experimental | Drug: BW-20805BW-20805 300 mg Q12W*2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have given written informed consent and be able to comply with all study requirements.
- Males or females 18 to 70 years of age at the time of informed consent.
- Documented diagnosis of HAE-1/HAE-2.
- At least 2 HAE attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition
- Access to and ability to use ≥ 1 acute medication(s)
Key exclusion criteria (12 listed)
- Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
- History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Have undergone major surgery within 3 months prior to screening.
- History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BW-20805SC administrations of BW-20805 600 mg on Day1 to Day673 | Drug | Cohort 1 |
| BW-20805SC administrations of BW-20805 300 mg every 24 weeks on Day1 to Day169;Day337 to Day673 | Drug | Cohort 2 |
| BW-20805SC administrations of BW-20805 300 mg every 12 weeks on Day 1 to Day 589 | Drug | Cohort 3 |
Primary outcome
To determine the prophylactic effect of in HAE attack rate.
Time frame: from baseline to Day169
Change in time-normalized monthly (per 4 weeks) HAE attack rate from baseline to Day169
1 secondary outcome
To evaluate the safety and tolerability of multiple doses of BW-20805.
Time frame: up to 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Magerl, Doctor principal investigator
Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BW-20805 in people with Hereditary Angioedema (HAE), run by Shanghai Argo Biopharmaceutical Co., Ltd. at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China, United States, Italy, Germany, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prophylactic effect of in HAE attack rate. (time frame: from baseline to Day169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.