Status:
ACTIVE_NOT_RECRUITING
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
Lead Sponsor:
CSL Behring
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
Eligibility Criteria
Inclusion
- Males and females aged ≥ 12 years
- Diagnosed with clinically confirmed C1-INH HAE
- Experienced ≥ 3 HAE attacks during the 3 months before Screening
- Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
- Experienced at least an average of 1 HAE attack per month during the Run-in Period
Exclusion
- Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
- Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
- Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
- Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
- Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
- Pregnant, breastfeeding, or not willing to cease breastfeeding
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT04739059
Start Date
April 29 2021
End Date
November 1 2025
Last Update
August 19 2025
Active Locations (44)
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1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
2
Research Solutions of Arizona
Litchfield Park, Arizona, United States, 85340
3
Medical Research of Arizona
Scottsdale, Arizona, United States, 85251
4
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States, 72205