NCT06846398Active, not recruitingPhase 2
A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects With Hereditary Angioedema
Shanghai Argo Biopharmaceutical Co., Ltd.32 sites in 6 countries25 target enrollmentStarted: February 28, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 32
- Primary Endpoint
- To determine the prophylactic effect of in HAE attack rate.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
Cohort 1
Experimental
BW-20805 600 mg Q24W*2
Intervention: BW-20805 (Drug)
Cohort 2
Experimental
BW-20805 300 mg Q24W*2
Intervention: BW-20805 (Drug)
Cohort 3
Experimental
BW-20805 300 mg Q12W*2
Intervention: BW-20805 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To evaluate the safety and tolerability of multiple doses of BW-20805.(up to 96 weeks)
Investigators
Study Sites (32)
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