Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
- Registration Number
- NCT04739059
- Lead Sponsor
- CSL Behring
- Brief Summary
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 171
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CSL312 CSL312 Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously
- Primary Outcome Measures
Name Time Method Number of subjects with treatment emergent adverse events (TEAEs) Up to 45 months TEAEs rates per injection Up to 45 months TEAEs rates per subject year Up to 45 months Percentage of subjects with TEAEs Up to 45 months
- Secondary Outcome Measures
Name Time Method The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment Up to 43 months Number and percentage of subjects rating their response to therapy as good or excellent Up to 43 months The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study Up to 43 months The number and percentage of subjects experiencing CSL312 induced anti-CSL312 antibodies Up to 45 months The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment Up to 43 months The percentage reduction and the number of subjects experiencing at least ≥ 50% ≥ 70%, ≥ 90 or equal to 100% (attack free) reduction in the time-normalized number of HAE attacks on Treatment compared to Run-in Period Up to 43 months The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths Up to 45 months The number and percentage of subjects experiencing TEAEs Up to 45 months The number and percentage of subjects experiencing adverse events of special interest (AESIs) Up to 45 months
Trial Locations
- Locations (44)
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Research Solutions of Arizona
🇺🇸Litchfield Park, Arizona, United States
Medical Research of Arizona
🇺🇸Scottsdale, Arizona, United States
Little Rock Allergy & Asthma Clinic
🇺🇸Little Rock, Arkansas, United States
Donald S. Levy M.D.
🇺🇸Orange, California, United States
Raffi Tachdjian MD, Inc.
🇺🇸Santa Monica, California, United States
Allergy & Asthma Clinical Research
🇺🇸Walnut Creek, California, United States
Institute for Asthma and Allergy PC
🇺🇸Chevy Chase, Maryland, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
PennState Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Scroll for more (34 remaining)Clinical Research Center of Alabama🇺🇸Birmingham, Alabama, United States