An Optional Investigation of Biomarkers of Efficacy

Circassia Pharmaceuticals

Status: Completed

Conditions: Rhinoconjunctivitis

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01949415

RES-008

Details and patient eligibility

About

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.

Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants

Enrollment: 105 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002.

Exclusion criteria

• Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)