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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04739059
Other study ID # CSL312_3002
Secondary ID 2020-003918-12
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 29, 2021
Est. completion date November 2025

Study information

Verified date June 2024
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Germany,  Hong Kong,  Hungary,  Israel,  Japan,  Netherlands,  New Zealand,  Russian Federation,  Spain,  Taiwan, 

Outcome

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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