ToleroMune House Dust Mite (HDM) Tolerability Study

NCT ID: NCT01949441

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-05-31

Brief Summary

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.

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.

Conditions

Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ToleroMune HDM

Group Type: EXPERIMENTAL

ToleroMune HDM

Intervention Type: BIOLOGICAL

Intradermal injection 1 x 4 administrations 4 weeks apart

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intradermal injection 1 x 4 administrations 4 weeks apart

Interventions

ToleroMune HDM

Intradermal injection 1 x 4 administrations 4 weeks apart

Intervention Type: BIOLOGICAL

Placebo

Intradermal injection 1 x 4 administrations 4 weeks apart

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiga Life Sciences, Inc.

INDUSTRY

Sponsor Role: collaborator

Circassia Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Topstone Research

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

TH004

Identifier Type: -

Identifier Source: org_study_id