ToleroMune House Dust Mite Follow on Study

Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923792
• Other study ID #: TH002a
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: May 14, 2014
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• House Dust Mite Allergy
• Rhinoconjunctivitis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Inflamax Research Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Scores		2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002	No
Secondary	Total Nasal Symptom Scores (TNSS)		Two years after the completion of the baseline EEC visit in TH002	No
Secondary	Der p Specific IgA		Two years after the completion of the baseline EEC visit in TH002	No
Secondary	Total Non Nasal Symptom Scores (TNNSS)		Two years after the completion of the baseline EEC visit in TH002	No
Secondary	Der P Specific IgE		Two years after the completion of the baseline EEC visit in TH002	No
Secondary	Der p specific IgG4		Two years after the completion of the baseline EEC visit in TH002	No