Effect of RP3128 on Allergen Challenge induced Late Asthmatic Response
Research type
Research Study
Full title
A Phase IIa, randomized, double-blind, placebo-controlled, parallel design study to evaluate the effect of RP3128, a CRAC channel modulator, on Allergen Challenge induced Late Phase Asthmatic Response (LAR) in patients with mild asthma.
IRAS ID
263215
Contact name
Ajit Nair
Contact email
Sponsor organisation
Rhizen Pharmaceuticals SA
Eudract number
2019-000956-33
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
A new experimental drug RP3128 is being developed to treat various inflammatory and airway diseases. The study drug aims to target the abnormal immune response (the body's response to the presence of a substance not usually found in the body) seen in those suffering with such diseases. One of the diseases that the study drug is being developed to treat is Asthma.
The purpose of this study, is to look at how effective the study drug is on patients with mild asthma. This will be done through measuring participants lung function response (change in breathing) to bronchial allergen challenges (breathing in a fine mist of the allergen that the participant is sensitive to), sputum (phlegm) sampling and blood sampling. The allergen test will help to measure the effect of the study drug through measuring the participants lung function response before and after intake of the study drug for 14 days. Participants sputum samples will be analysed to look for changes in inflammatory cells following treatment with the study drug. Blood samples for Pharmacokinetic (PK) analysis will measure the levels of the study medication in the body and the time it takes for the body to break it down.
The study will also compare the study drug to a placebo (‘dummy’ drug with no active ingredients) as a control, which allows the true effect of the experimental drug to be evaluated.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0164
Date of REC Opinion
18 Apr 2019
REC opinion
Unfavourable Opinion