ToleroMune House Dust Mites (HDM) Exposure Chamber Study

This study has been completed.
Sponsor:
Collaborators:
Adiga Life Sciences
Cetero Research, San Antonio
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01447784
First received: October 5, 2011
Last updated: July 16, 2013
Last verified: July 2013
  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 a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of HDM allergy

This study will look at the efficacy, safety and tolerability of three doses of ToleroMune HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental Exposure Chamber (EEC)).


Condition Intervention Phase
Rhinoconjunctivitis
Biological: ToleroMune HDM
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber.

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Total Rhinoconjunctivitis Symptom Score [ Time Frame: Up to 47 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom scores for nasal and non-nasal symptoms [ Time Frame: Up to 47 weeks ] [ Designated as safety issue: No ]
  • Total Rhinoconjunctivitis Symptom Score [ Time Frame: Up to 19 weeks ] [ Designated as safety issue: No ]
  • Total Rhinoconjunctivitis Symptom Score [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
  • HDM specific IgA [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: No ]
  • HDM specific IgE [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: No ]
  • HDM specific IgG4 [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Upto 53 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 172
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: Placebo
Intradermal injection 1 x 11 administrations 4 weeks apart
Experimental: ToleroMune HDM Dose 1 Biological: ToleroMune HDM
Intradermal injection 1 x 11 administrations 4 weeks apart
Experimental: ToleroMune HDM Dose 2 Biological: ToleroMune HDM
Intradermal injection 1 x 11 administrations 4 weeks apart
Experimental: ToleroMune HDM Dose 3 Biological: ToleroMune HDM
Intradermal injection 1 x 11 administrations 4 weeks apart

Detailed Description:

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune HDM in HDM allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Ragweed will be explored in subjects using an EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 3 visits to the EEC. Eligible subjects will complete a daily diary card at home for two weeks following the final visit to the EEC.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment over 11 visits in 3 dosing periods for each subject. Within each dosing period visits will take place at intervals of 4 weeks (28±2 days). There will also be two EEC visits during the treatment period and one post treatment EEC visit. Following the final visit to the EEC, subjects will complete a daily diary card at home for two weeks.

In Period 3, Follow-up will be conducted 16-21 days after the final EEC visit.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Male or female, aged 18-65 years.
  • Minimum 1-year documented history of rhinoconjunctivitis on exposure to HDM.
  • Positive skin prick test to Der p allergen.
  • Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

  • History of asthma (asthma in childhood .
  • A history of anaphylaxis to HDM allergen.
  • Subjects with an FEV1 <80% of predicted.
  • Subjects who cannot tolerate baseline challenge in the EEC.
  • Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
  • A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
  • A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447784

Locations
Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences
Cetero Research, San Antonio
Investigators
Principal Investigator: Deepen Patel, MD, CCFP Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01447784     History of Changes
Other Study ID Numbers: TH002
Study First Received: October 5, 2011
Last Updated: July 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
HDM allergy
Rhinoconunctivitis
Environmental Exposure Chamber
Immunotherapy
ToleroMune HDM

ClinicalTrials.gov processed this record on September 18, 2014