This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Rhinoconjunctivitis

ToleroMune House Dust Mites (HDM) Exposure Chamber Study

Sponsored by Circassia Limited

About this trial

Last updated 12 years ago

Study ID

TH002

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 12 years ago

What is this trial about?

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens 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 HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of HDM allergy This study will look at the efficacy, safety and tolerability of three doses of ToleroMune HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental Exposure Chamber (EEC)).

What are the participation requirements?

Yes

Inclusion Criteria

- Male or female, aged 18-65 years.

- Minimum 1-year documented history of rhinoconjunctivitis on exposure to HDM.

- Positive skin prick test to Der p allergen.

- Minimum qualifying rhinoconjunctivitis symptom scores

No

Exclusion Criteria

- History of asthma (asthma in childhood .

- A history of anaphylaxis to HDM allergen.

- Subjects with an FEV1 <80% of predicted.

- Subjects who cannot tolerate baseline challenge in the EEC.

- Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).

- A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.

- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).