ToleroMune House Dust Mite (HDM) Tolerability Study

Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949441
• Other study ID #: TH004
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2013
• Last updated: June 10, 2014
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinoconjunctivitis

Intervention

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

Locations

Country	Name	City	State
Canada	Topstone Research	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Up to 19 Weeks	Yes
Secondary	FEV1 and FVC		Up to 19 Weeks	No
Secondary	Peak Expiratory Flow Rate		Up to 19 Weeks	No
Secondary	VAS Breathlessness		Up to 19 weeks	No
Secondary	Asthma Exacerbations		Up to 19 weeks	No
Secondary	Systemic Allergic Reactions		Up to 19 Weeks	No
Secondary	Injection Site Examinations		Up to 19 Weeks	No