Hereditary Angioedema Clinical Trial
Official title:
An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
Verified date | June 2024 |
Source | CSL Behring |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
Status | Active, not recruiting |
Enrollment | 171 |
Est. completion date | November 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Campbelltown Hospital / Western Sydney University | Campbelltown | New South Wales |
Australia | The Alfred Hospital | Melbourne | Victoria |
Australia | Fiona Stanley Hospital, Department of Clinical Immunology | Murdoch | West Australia |
Canada | University of Alberta - Research Transition Facility | Edmonton | Alberta |
Canada | McMaster University | Hamilton | Ontario |
Canada | Montreal Clinical Research Institute | Montréal | Quebec |
Canada | Ottawa Allergy Research Corp | Ottawa | Ontario |
Canada | Gordon Sussman Clinical Research | Toronto | Ontario |
Czechia | University hospital St. Anna Ustav klinicke imunologie a alergologie, Fakultní nemocnice u sv. Anny v Brne | Brno | |
Czechia | University Hospital Motol | Praha 5 | |
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Universitätsklinikum Frankfurt | Frankfurt | |
Germany | Johannes Gutenberg-Universität KöR, Hautklinik und Poliklinik der Universitätsmedizin, Clinical Research Center | Mainz | |
Germany | HZRM Haemophilie Zentrum Rhein Main GmbH | Mörfelden-Walldorf | |
Hong Kong | The University of Hong Kong, Queen Mary Hospital | Hong Kong | |
Hungary | Semmelweis Egyetem Altalanos Orvostudományi Kar Belgyógyászati és Hematológiai Klinika | Budapest | |
Israel | Barzilai University Medical Center | Ashkelon | |
Japan | Clover Hospital | Kanagawa | Kugenumaishigami, Fujisawa-shi |
Japan | St. Marianna University School of Medicine Hospital | Kanagawa | Kawasaki-shi |
Japan | Mie University Hospital | Mie | Edobashi, Tsu-shi |
Japan | Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital | Miyakojima-ku | Osaka-shi |
Japan | Saga University Hospital | Saga | Nebeshima, Saga-shi |
Japan | Saitama Medical Center | Saitama | Kamoda Kawagoe-shi |
Japan | Saiyu Soka Hospital | Saitama | Matsubara Soka-shi |
Japan | Koga Community Hospital | Shizuoka | Daikakuji Yaizu-shi |
Japan | Juntendo University Hospital | Tokyo | Hongo Bunkyo-ku |
Japan | National Hospital Organization Disaster Medical Center | Tokyo | Midoricho, Tachikawa-shi |
Netherlands | Amsterdam UMC, location AMC | Amsterdam | |
New Zealand | Auckland City Hospital | Grafton | Auckland |
Russian Federation | NRC Institute of Immunology FMBA Russia | Moscow | |
Spain | Hospital Universitari General de La Vall d'Hebron | Barcelona | |
Spain | Hospital Gregorio Marañón, Servicio de Alergia | Madrid | |
Taiwan | Taichung Veterans General Hospital | Taichung City | |
United States | Clinical Research Center of Alabama | Birmingham | Alabama |
United States | Institute for Asthma and Allergy PC | Chevy Chase | Maryland |
United States | Bernstein Clinical Research Center, LLC | Cincinnati | Ohio |
United States | AARA Research Center | Dallas | Texas |
United States | PennState Health Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Research Solutions of Arizona | Litchfield Park | 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 | Medical Research of Arizona | Scottsdale | Arizona |
United States | Allergy & Asthma Clinical Research | Walnut Creek | California |
Lead Sponsor | Collaborator |
---|---|
CSL Behring |
United States, Australia, Canada, Czechia, Germany, Hong Kong, Hungary, Israel, Japan, Netherlands, New Zealand, Russian Federation, Spain, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with treatment emergent adverse events (TEAEs) | Up to 45 months | ||
Primary | Percentage of subjects with TEAEs | Up to 45 months | ||
Primary | TEAEs rates per injection | Up to 45 months | ||
Primary | TEAEs rates per subject year | Up to 45 months | ||
Secondary | The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study | Up to 43 months | ||
Secondary | 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 | ||
Secondary | The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment | Up to 43 months | ||
Secondary | The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment | Up to 43 months | ||
Secondary | Number and percentage of subjects rating their response to therapy as good or excellent | Up to 43 months | ||
Secondary | The number and percentage of subjects experiencing TEAEs | Up to 45 months | ||
Secondary | The number and percentage of subjects experiencing adverse events of special interest (AESIs) | Up to 45 months | ||
Secondary | The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths | Up to 45 months | ||
Secondary | The number and percentage of subjects experiencing CSL312 induced anti-CSL312 antibodies | Up to 45 months |
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