ToleroMune House Dust Mite Follow on Study

NCT ID: NCT01923792

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-04-30

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.

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.

Conditions

House Dust Mite Allergy; Rhinoconjunctivitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Placebo

Subjects previously randomised to receive placebo in study TH002

No interventions assigned to this group

ToleroMune HMD Group 1

Subjects previously randomised to receive ToleroMune HDM in study TH002

No interventions assigned to this group

ToleroMune HDM Group 2

Subjects previously randomised to receive ToleroMune HDM in study TH002

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiga Life Sciences, Inc.

INDUSTRY

Sponsor Role: collaborator

Inflamax Research Incorporated

INDUSTRY

Sponsor Role: collaborator

Circassia Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TH002a

Identifier Type: -

Identifier Source: org_study_id