ToleroMune House Dust Mite (HDM) Tolerability Study

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis

House Dust Mites (HDMs) 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), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.

This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.

Study Overview

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

Detailed Description

A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9C 4Z5
      • Topstone 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.
• Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
• Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
• No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
• A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
• Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control.
• ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L.

Exclusion Criteria:

• History of life-threatening asthma
• Asthma exacerbation in the 12 weeks prior to randomisation
• Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause.
• Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7.
• Concurrent respiratory disease that would confound study participation or affect subject safety.

• Non-HDM allergy that may significantly interfere with the results of this study.

  7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Biological: Placebo; Intradermal injection 1 x 4 administrations 4 weeks apart
EXPERIMENTAL: ToleroMune HDM	Biological: ToleroMune HDM; Intradermal injection 1 x 4 administrations 4 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	Up to 19 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
FEV1 and FVC	Up to 19 Weeks
Peak Expiratory Flow Rate	Up to 19 Weeks
VAS Breathlessness	Up to 19 weeks
Asthma Exacerbations	Up to 19 weeks
Systemic Allergic Reactions	Up to 19 Weeks
Injection Site Examinations	Up to 19 Weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Adiga Life Sciences, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (ESTIMATE): September 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2014
• Last Update Submitted That Met QC Criteria: June 10, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Immunotherapy; Rhinoconjunctivitis; HDM Allergy; ToleroMune HDM
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: TH004