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Safety of ToleroMune House Dust Mite (HDM) to Treat House Dust Mite Allergy in HDM Allergic Subjects With Rhinoconjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008332
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : November 10, 2010
Sponsor:
Collaborator:
Adiga Life Sciences, Inc.
Information provided by:
Circassia Limited

Brief Summary:

The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to region and depends on the regional prevalence of HDM. In the third National Health and Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms.

ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of Houst Dust Mite allergy.

The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune HDM in subjects in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin Response and Conjunctival Provocation Test.


Condition or disease Intervention/treatment Phase
Allergy Biological: Toleromune HDM Biological: Placebo Phase 2

Detailed Description:

This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune HDM in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the LPSR, EPSR, CPT and levels of HDM specific IgE. A single centre will be initiated first, with a second centre included as a backup, if needed, to enable recruitment numbers to be met.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 8 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of a single visit 1 to 4 weeks before randomisation.

Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart (28±2 days). Subjects who comply with the inclusion/exclusion criteria will be assigned to one of 5 dose groups. The first dose group will receive 4 administrations of ToleroMune HDM. Successive dose groups will increasing doses given as 4 administrations of ToleroMune HDM, provided the first administration of the previous dose was safe and well tolerated.

In Period 3, Post-treatment Challenge will take place 18-22 weeks after the first administration in the Treatment Period. Assessments performed will be identical to those at the Baseline Challenge. Follow-up will be conducted 3-10 days after PTC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Escalating, Multiple-dose Study in House Dust Mite Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune HDM
Study Start Date : November 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Odactra

Arm Intervention/treatment
Experimental: Cohort 1
ToleroMune HDM, subjects to receive either active or placebo comparator
Biological: Toleromune HDM
ToleroMune HDM dose 1x4 administrations 4 weeks apart

Biological: Placebo
Placebo comparator, 1x4 administrations 4 weeks apart

Experimental: Cohort 2
ToleroMune HDM, subjects to receive either active or placebo comparator
Biological: Toleromune HDM
ToleroMune HDM dose 1x4 administrations 4 weeks apart

Biological: Placebo
Placebo comparator, 1x4 administrations 4 weeks apart

Experimental: Cohort 3
ToleroMune HDM, subjects to receive either active or placebo comparator
Biological: Toleromune HDM
ToleroMune HDM dose 1x4 administrations 4 weeks apart

Biological: Placebo
Placebo comparator, 1x4 administrations 4 weeks apart

Experimental: Cohort 4
ToleroMune HDM, subjects to receive either active or placebo comparator
Biological: Toleromune HDM
ToleroMune HDM dose 1x4 administrations 4 weeks apart

Biological: Placebo
Placebo comparator, 1x4 administrations 4 weeks apart

Experimental: Cohort 5
Toleromune HDM, subjects to receive either active or placebo comparator
Biological: Toleromune HDM
ToleroMune HDM dose 1x4 administrations 4 weeks apart

Biological: Placebo
Placebo comparator, 1x4 administrations 4 weeks apart




Primary Outcome Measures :
  1. Safety and tolerability of multiple intradermal injections of ToleroMune HDM in HDM allergic subjects with allergic rhinoconjunctivitis [ Time Frame: 18-22 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo [ Time Frame: 18-22 weeks ]
  2. Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo [ Time Frame: 18-22 weeks ]
  3. Mean change from baseline in CPT score at PTC after ToleroMune HDM injection compared to placebo [ Time Frame: 18-22 weeks ]
  4. Mean change from baseline in concentration of HDM specific IgE at PTC after ToleroMune HDM injection compared to placebo [ Time Frame: 18-22 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18-65 years
  • Miniumum 1 year history of rhinoconjunctivitis on exposure to HDM
  • Positive skin prick test to whole Der p allergen
  • LPSR to whole Der p allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
  • Positive CPT to whole Der p allergen with a score ≥4

Exclusion Criteria:

  • Subjects with a history of asthma
  • Subjects with an FEV1 <80% of predicted
  • Subjects with a Der f or Der p specific IgE >100 kU/L
  • Subjects with an acute phase skin response to whole Der p or whole Der f allergen with a mean wheal diameter > 50 mm
  • Subjects who score >1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
  • Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillizers or psychoactive drugs
  • History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008332


Locations
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Canada, Quebec
Centre de Recherche Appliqué en Allergie de Québec
Quebec City, Quebec, Canada
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.
Investigators
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Principal Investigator: Jacques Hebert, MD Centre de Recherche Appliqué en Allergie de Québec
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Responsible Party: Dr Rod Hafner, VP R&D, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01008332    
Other Study ID Numbers: TH001
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: November 2010
Keywords provided by Circassia Limited:
House Dust Mite Allergy
Immunotherapy
Rhinoconjunctivitis
Toleromune HDM
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases