HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
ID Number 16-0622Principal Investigator(s)
Paula J Busse
Department(s) or Division(s)
Allergy and Immunology
The purpose of this study is to:
- Evaluate if DX-2930 can prevent HAE attacks
- Test the safety of DX-2930
- Test subject's blood to see how DX-2930 affects them
- Help understand if DX-2930 affects the subject's day-to-day life
The test medicine being studied is called DX-2930. DX-2930 is a 'monoclonal antibody' - these are man made versions of the proteins (antibodies) that the immune system makes to attach to specific targets in the body. DX-2930 blocks an enzyme called plasma kallikrein. This test medicine is undergoing research to see if it can prevent HAE attacks and if it is safe or not.
All subjects who qualify and participate in the study will get the study drug by subcutaneous injection (under the skin by a needle) in the upper arm. Some subjects will receive DX-2930 and some study subjects will receive placebo. The placebo looks like DX-2930 but does not have any real medication in it.
This is a "double-blind study," which means neither the subject nor the study doctor will know whether they are given DX-2930 or placebo. In case of an emergency, however, the study doctor can get this information.
The subject's participation in this research study is expected to last approximately 7-10 months after their first visit (the Screening visit) with the study doctor.
The number of people expected to take part in this research study at this site is 10. Approximately 120 subjects across the US, Canada, Germany, Italy, the United Kingdom and Jordan will participate. No more than 80 subjects will get DX-2930 and no more than 40 subjects will get the placebo.
Recruiting Patients: No