ToleroMune House Dust Mite (HDM) Tolerability Study

NCT01949441 | Completed Phase 2

• 1 other identifier: TH004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinoconjunctivitis

Keywords

HDM Allergy; Rhinoconjunctivitis; Immunotherapy; ToleroMune HDM

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Up to 19 Weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

ToleroMune HDM

EXPERIMENTAL

Biological: ToleroMune HDM

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

ToleroMune HDM BIOLOGICAL

Intradermal injection 1 x 4 administrations 4 weeks apart

ToleroMune HDM

Placebo BIOLOGICAL

Intradermal injection 1 x 4 administrations 4 weeks apart

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (1)

Topstone Research

Toronto, Ontario, M9C 4Z5, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

CA (1)