A Phase 2 in Adult Subjects With Hereditary Angioedema (HAE)

Shanghai Argo Biopharmaceutical Co., Ltd.

Status and phase: Not yet enrolling; Phase 2

Conditions: Hereditary Angioedema (HAE)

Treatments: Drug: BW-20805

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846398

BW-20805-2001

Details and patient eligibility

About

A Phase 2 in Adult Subjects with Hereditary Angioedema

Full description

A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Cohort 1

Experimental group

Description:

BW-20805 600 mg Q24W\*2

Treatment:

Drug: BW-20805

Drug: BW-20805

Drug: BW-20805

Cohort 2

Experimental group

Description:

BW-20805 300 mg Q24W\*2

Treatment:

Drug: BW-20805

Drug: BW-20805

Drug: BW-20805

Cohort 3

Experimental group

Description:

BW-20805 300 mg Q12W\*2

Treatment:

Drug: BW-20805

Drug: BW-20805

Drug: BW-20805