ToleroMune House Dust Mite Follow on Study

This study has been completed.
Sponsor:
Collaborators:
Adiga Life Sciences
Inflamax Research Incorporated
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01923792
First received: July 16, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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
House Dust Mite Allergy
Rhinoconjunctivitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Total Rhinoconjunctivitis Symptom Scores [ Time Frame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Nasal Symptom Scores (TNSS) [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ] [ Designated as safety issue: No ]
  • Der p Specific IgA [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ] [ Designated as safety issue: No ]
  • Total Non Nasal Symptom Scores (TNNSS) [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ] [ Designated as safety issue: No ]
  • Der P Specific IgE [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ] [ Designated as safety issue: No ]
  • Der p specific IgG4 [ Time Frame: Two years after the completion of the baseline EEC visit in TH002 ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01923792     History of Changes
Other Study ID Numbers: TH002a
Study First Received: July 16, 2013
Last Updated: May 14, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 18, 2014