A Study in Adult Patients with Allergic Asthma
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 plus Dupilumab on Markers of Inflammation after Bronchial Allergen Challenge in Patients with Allergic Asthma.
IRAS ID
220608
Contact name
Dave Singh
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2016-003165-26
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
This study is split into 2 parts: \nPart 1 - Two investigational drugs are being studied (called REGN3500 and Dupilumab), which are being developed for the treatment of moderate to severe asthma. In people who are allergic, exposure to inhaled allergens, such as pollen, cats, house dust mite etc can lead to changes in parts of the immune system that are responsible for common allergy symptoms, such as sneezing, runny nose, nasal congestion and itching, as well as asthma symptoms, such as cough, chest tightness, wheezing etc. As the study drugs, REGN3500 and Dupilumab are products that can modulate or block part of the immune system, they can potentially lower the allergic reactivity in people with allergies, therefore potentially reducing symptoms. \n\nThe study drugs will be given separately or in combination (via injection under the skin for Dupilumab and via infusion into a vein for REGN3500) and compared with placebo. \n\nPart 2 - This part of the study will be similar to part 1 however the treatment that will be given is different (a licenced medication available on prescription called Fluticasone Propionate, which has been available for the treatment of asthma for many years). This part of the study will serve as a positive control to provide a comparator to evaluate the effects of the study drugs on allergen induced lung inflammation. \n\nDuring both parts of the study, patient’s responses to allergen will be measured using tests called bronchial allergen challenges. The allergen tests will help to measure the effect of the study drug. \n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0163
Date of REC Opinion
5 Apr 2017
REC opinion
Further Information Favourable Opinion