Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

Completed · Phase 3

Conditions studied: Hereditary Angioedema

In brief

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

Key facts

Study ID

NCT04739059

Run by

CSL Behring

People needed

171

Starts

2021-03-29

Expected to finish

2025-11-21

Last updated by the study team

2026-06-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• AARA Research Center — Dallas, Texas, United States
• Campbelltown Hospital / Western Sydney University — Campbelltown, New South Wales, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Fiona Stanley Hospital, Department of Clinical Immunology — Murdoch, Western Australia, Australia
• University of Alberta - Research Transition Facility — Edmonton, Alberta, Canada
• McMaster University — Hamilton, Ontario, Canada
• Ottawa Allergy Research Corp — Ottawa, Ontario, Canada
• Gordon Sussman Clinical Research — Toronto, Ontario, Canada
• Montreal Clinical Research Institute — Montreal, Quebec, Canada
• University hospital St. Anna Ustav klinicke imunologie a alergologie, Fakultní nemocnice u sv. Anny v Brně — Brno, Czechia
• University Hospital Motol — Prague, Czechia
• 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, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.