Clinical trial NCT06846398: A Phase 2 in Adult Subjects With Hereditary Angioedema
Official title: A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects With Hereditary Angioedema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: To determine the prophylactic effect of in HAE attack rate.
timeFrame: from baseline to Day169
Secondary outcomes:
measure: To evaluate the safety and tolerability of multiple doses of BW-20805.
timeFrame: up to 96 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey MC - Penn State
state: Pennsylvania
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie
name: Markus Magerl, Doctor
role: PRINCIPAL_INVESTIGATOR
References: