ToleroMune House Dust Mites (HDM) Exposure Chamber Study

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.

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)).

Study Overview

• Status: Completed
• Conditions: Rhinoconjunctivitis
• Intervention / Treatment: Biological: Placebo; Biological: ToleroMune HDM

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Intradermal injection 1 x 11 administrations 4 weeks apart
Experimental: ToleroMune HDM Dose 1	Biological: ToleroMune HDM; Intradermal injection 1 x 11 administrations 4 weeks apart
Experimental: ToleroMune HDM Dose 2	Biological: ToleroMune HDM; Intradermal injection 1 x 11 administrations 4 weeks apart
Experimental: ToleroMune HDM Dose 3	Biological: ToleroMune HDM; Intradermal injection 1 x 11 administrations 4 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Rhinoconjunctivitis Symptom Score	Up to 47 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom scores for nasal and non-nasal symptoms	Up to 47 weeks
Total Rhinoconjunctivitis Symptom Score	Up to 19 weeks
Total Rhinoconjunctivitis Symptom Score	Up to 36 weeks
HDM specific IgA	Up to 53 weeks
HDM specific IgE	Up to 53 weeks
HDM specific IgG4	Up to 53 weeks
Adverse Events	Upto 53 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Cetero Research, San Antonio; Adiga Life Sciences, Inc.
• Investigators: Principal Investigator: Deepen Patel, MD, CCFP, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Immunotherapy; Environmental Exposure Chamber; ToleroMune HDM; HDM allergy; Rhinoconunctivitis
• Other Study ID Numbers: TH002