ToleroMune House Dust Mites (HDM) Exposure Chamber Study

Phase 2

Completed

• Conditions: Rhinoconjunctivitis
• Interventions: Biological: ToleroMune HDM; Biological: Placebo

• Registration Number: NCT01447784
• Lead Sponsor: Circassia Limited

Brief 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)).

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-16
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ToleroMune HDM Dose 1	ToleroMune HDM	-
Placebo	Placebo	-
ToleroMune HDM Dose 2	ToleroMune HDM	-
ToleroMune HDM Dose 3	ToleroMune HDM	-

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Score	Up to 47 weeks

Secondary Outcome Measures

Name	Time	Method
Symptom scores for nasal and non-nasal symptoms	Up to 47 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

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada