ToleroMune House Dust Mite Follow on Study

May 14, 2014 updated by: Circassia Limited

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Rhinoconjunctivitis Symptom Scores
Time Frame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002
2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Nasal Symptom Scores (TNSS)
Time Frame: Two years after the completion of the baseline EEC visit in TH002
Two years after the completion of the baseline EEC visit in TH002
Der p Specific IgA
Time Frame: Two years after the completion of the baseline EEC visit in TH002
Two years after the completion of the baseline EEC visit in TH002
Total Non Nasal Symptom Scores (TNNSS)
Time Frame: Two years after the completion of the baseline EEC visit in TH002
Two years after the completion of the baseline EEC visit in TH002
Der P Specific IgE
Time Frame: Two years after the completion of the baseline EEC visit in TH002
Two years after the completion of the baseline EEC visit in TH002
Der p specific IgG4
Time Frame: Two years after the completion of the baseline EEC visit in TH002
Two years after the completion of the baseline EEC visit in TH002

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Adiga Life Sciences, Inc.
Inflamax Research Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH002a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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