ToleroMune House Dust Mites (HDM) Exposure Chamber Study

Rhinoconjunctivitis Clinical Trial

Official title:

A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447784
• Other study ID #: TH002
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2011
• Last updated: July 16, 2013
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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)).

Description:

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune HDM in HDM allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Ragweed will be explored in subjects using an EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 3 visits to the EEC. Eligible subjects will complete a daily diary card at home for two weeks following the final visit to the EEC.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment over 11 visits in 3 dosing periods for each subject. Within each dosing period visits will take place at intervals of 4 weeks (28±2 days). There will also be two EEC visits during the treatment period and one post treatment EEC visit. Following the final visit to the EEC, subjects will complete a daily diary card at home for two weeks.

In Period 3, Follow-up will be conducted 16-21 days after the final EEC visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinoconjunctivitis

Intervention

Biological:
• ToleroMune HDM
Intradermal injection 1 x 11 administrations 4 weeks apart
• Placebo
Intradermal injection 1 x 11 administrations 4 weeks apart

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Cetero Research, San Antonio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		Up to 47 weeks	No
Secondary	Symptom scores for nasal and non-nasal symptoms		Up to 47 weeks	No
Secondary	Total Rhinoconjunctivitis Symptom Score		Up to 19 weeks	No
Secondary	Total Rhinoconjunctivitis Symptom Score		Up to 36 weeks	No
Secondary	HDM specific IgA		Up to 53 weeks	No
Secondary	HDM specific IgE		Up to 53 weeks	No
Secondary	HDM specific IgG4		Up to 53 weeks	No
Secondary	Adverse Events		Upto 53 weeks	Yes