MK-8237-009 House Dust Mite Biomarker Study
Research type
Research Study
Full title
A Two Part, Randomized Clinical Trial to Study Biomarkers of MK-8237 (SCH 900237) Treatment in Subjects with House Dust Mite Induced Allergic Rhinitis or Rhinoconjunctivitis
IRAS ID
131842
Contact name
Trevor Hansel
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Eudract number
2012-005621-70
Clinicaltrials.gov Identifier
Research summary
Amongst the significant aeroallergens, house dust mite (HDM) is notable as the most frequent allergen to which allergy and asthma patients are sensitive. The Global Allergy and Asthma European Network (GA2LEN) estimated that >50% of such patients in the UK and Ireland are sensitized.
This study will look at the drug, MK-8237 which contains house dust mite allergen extracts. This study will look at how this drug affects levels of certain HDM allergy biomarkers and general HDM allergic symptoms.
This will be done by assessing the differences between the levels of dust mite specific biological markers in the blood and samples taken from the nose before and after treatment MK-8237.
This study has been designed as a two part, randomized clinical trial. The objective of Part 1 is to verify that technical execution of study procedures is feasible and can be performed sufficiently well before proceeding to Part 2; consequently, no data analysis will be performed as part of Part 1. The main objective of Part 2 is to determine, at 12 weeks, the mean change from baseline in special biological markers of HDM alergy in the blood, called HDM-specific-IgG4 and -IgE blocking factor (IgE-BF) in response to the study drug, MK-8237.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0383
Date of REC Opinion
18 Sep 2013
REC opinion
Further Information Favourable Opinion