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Completed

NCT Number: NCT01923792

ToleroMune House Dust Mite Follow on Study

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.

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Key information

Conditions

House Dust Mite Allergy Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinoconjunctivitis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Scores

    Time frame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Inflamax Research Incorporated

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 16, 2013
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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