Study of REGN1908-1909 in volunteers with allergic rhinitis
Research type
Research Study
Full title
A single dose study of the efficacy, safety, tolerability, and pharmacokinetics of REGN1908-1909 in allergic rhinitis subjects challenged intranasally with allergen extract
IRAS ID
153143
Contact name
Timothy G K Mant
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2013-004950-68
Clinicaltrials.gov Identifier
Clinical Trials gov identifier, NCT02127801
Research summary
This research study involves a new drug, REGN1908-1909 which is being developed by Regeneron Pharmaceuticals, Inc., the sponsoring drug company, for the prevention of cat allergy symptoms in adults who are allergic to cats.
REGN1908-1909 has been previously studied in human beings in one research study.
The purposes of this study are to assess the efficacy, safety and tolerability of a single dose of REGN1908-1909 in cat-allergic adult volunteers, to collect information about how much REGN1908-1909 is in blood over time, and to collect information about how the body reacts to REGN1908-1909.
REGN1908-1909 is a type of drug called a “monoclonal antibody”. Antibodies are proteins that your body makes to help fight against different types of diseases. REGN1908-1909 is an “investigational” drug, which means that it has not been approved by regulatory authorities to be available on the market for prescription to patients but may be tested in research studies such as this one. The investigational drug REGN1908-1909 combines two proteins that may help body block cat allergy symptoms.
Approximately 70 volunteers are expected to participate in this study from approximately 5 study sites in Europe and the Asia-Pacific region. There will be approximately 10-20 volunteers enrolled at each site.
Volunteers will either receive REGN1908-1909 or placebo (dummy drug) in a randomised manner (purely by chance like tossing a coin).
This study will involve 8 visits over 16 weeks or approximately 4 months. There is an initial screening period of approximately 4 weeks, which will consist of 2 visits approximately 2 weeks apart.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0294
Date of REC Opinion
5 Jun 2014
REC opinion
Further Information Favourable Opinion