CClinicalTrials.gg
Sign In
CompletedNCT01949441Updated Jun 11, 2014

ToleroMune House Dust Mite (HDM) Tolerability Study

A Phase 2 interventional study of ToleroMune HDM and Placebo in Rhinoconjunctivitis, sponsored by Circassia Limited. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-11.

Sponsored by Circassia Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rhinoconjunctivitis

Browse trials for

Keywords

  • HDM Allergy
  • Rhinoconjunctivitis
  • Immunotherapy
  • ToleroMune HDM
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Circassia Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

    1. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    ToleroMune HDM

    Biological: ToleroMune HDM

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalToleroMune HDM

    Intradermal injection 1 x 4 administrations 4 weeks apart

  • BiologicalPlacebo

    Intradermal injection 1 x 4 administrations 4 weeks apart

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Time frame: Up to 19 Weeks

Secondary outcomes

  1. FEV1 and FVC

    Time frame: Up to 19 Weeks

  2. Peak Expiratory Flow Rate

    Time frame: Up to 19 Weeks

  3. VAS Breathlessness

    Time frame: Up to 19 weeks

  4. Asthma Exacerbations

    Time frame: Up to 19 weeks

  5. Systemic Allergic Reactions

    Time frame: Up to 19 Weeks

  6. Injection Site Examinations

    Time frame: Up to 19 Weeks

07

Study locations

1 site
  • Topstone Research
    Toronto, Ontario M9C 4Z5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01949441
Lead sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
Responsible party
Sponsor
First posted
Sep 24, 2013
Start date
Sep 2013
Primary completion
May 2014
Completion
May 2014
Last update
Jun 11, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Conjunctivitis→

Other studies from this sponsor

Circassia Limited

Start the discussion