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ToleroMune House Dust Mite Follow on Study

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ClinicalTrials.gov Identifier: NCT01923792
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : May 15, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens 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 HDM is currently being developed for the treatment of HDM allergy.

The Purpose of this optional observational follow-on study is to evaluate the continued efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline approximately two years after the completion of the baseline EEC visit in TH002 following challenge with HDM allergen in an EEC.


Condition or disease
House Dust Mite Allergy Rhinoconjunctivitis

Detailed Description:
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Study Design

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber
Study Start Date : September 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014
Groups and Cohorts

Group/Cohort
Placebo
Subjects previously randomised to receive placebo in study TH002
ToleroMune HMD Group 1
Subjects previously randomised to receive ToleroMune HDM in study TH002
ToleroMune HDM Group 2
Subjects previously randomised to receive ToleroMune HDM in study TH002


Outcome Measures

Primary Outcome Measures :
  1. Total Rhinoconjunctivitis Symptom Scores [ Time Frame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002 ]

Secondary Outcome Measures :
  1. Total Nasal Symptom Scores (TNSS) [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ]
  2. Der p Specific IgA [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ]
  3. Total Non Nasal Symptom Scores (TNNSS) [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ]
  4. Der P Specific IgE [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ]
  5. Der p specific IgG4 [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously randomised in study TH002 and completed all dosing visits and the PTC
Criteria

Inclusion Criteria:

  • previously randomised in study TH002, completed all dosing visits and the PTC

Exclusion Criteria:

  • "Partly controlled" and "uncontrolled" asthma
  • History of anaphylaxis to House Dust Mite allergen
  • FEV1 <80% of predicted.
  • Symptoms of a clinically relevant illness
  • Subjects who cannot tolerate allergen challenge in the EEC
More Information

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01923792     History of Changes
Other Study ID Numbers: TH002a
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014

Keywords provided by Circassia Limited:
House Dust Mite Allergy
Rhinoconjunctivitis
Environmental Exposure Unit
Immunotherapy
ToleroMune HDM

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases