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Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis

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ClinicalTrials.gov Identifier: NCT01166061
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : May 20, 2011
Sponsor:
Collaborator:
Adiga Life Sciences, Inc.
Information provided by:
Circassia Limited

July 8, 2010
July 20, 2010
May 20, 2011
July 2010
April 2011   (Final data collection date for primary outcome measure)
Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis [ Time Frame: Upto 22 weeks ]
  • Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis [ Time Frame: 14 weeks ]
  • Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis [ Time Frame: 17 weeks ]
Complete list of historical versions of study NCT01166061 on ClinicalTrials.gov Archive Site
  • Area of Late Phase Skin Response [ Time Frame: Baseline and 14 weeks ]
  • Area of Early Phase Skin Response [ Time Frame: Baseline and 14 weeks ]
  • Change in CPT score [ Time Frame: Baseline and 4 weeks ]
  • Grass specific IgG4 [ Time Frame: Baseline and 14 weeks ]
  • Change in CPT score [ Time Frame: Baseline and 14 weeks ]
  • Area of Early Phase Skin Response [ Time Frame: Baseline and 17 weeks ]
  • Grass specific IgE [ Time Frame: Baseline and 17 weeks ]
  • Area of Late Phase Skin Response [ Time Frame: Baseline and 17 weeks ]
  • Change in CPT score [ Time Frame: 17 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: Baseline and 8 weeks ]
  • Change in CPT score [ Time Frame: Baseline and 12 weeks ]
  • Grass specific IgE [ Time Frame: Baseline and 14 weeks ]
  • Area of Late Phase Skin Response [ Time Frame: 0 weeks after start of treatment ]
  • Area of Early Phase Skin Response [ Time Frame: 0 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: 0 weeks after start of treatment ]
  • Grass specific IgE [ Time Frame: 0 weeks after start of treatment ]
  • Grass specific IgG4 [ Time Frame: 14 weeks after start of treatment ]
  • Area of Late Phase Skin Response [ Time Frame: 14 weeks after start of treatment ]
  • Area of Early Phase Skin Response [ Time Frame: 14 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: 14 weeks after start of treatment ]
  • Area of Early Phase Skin Response [ Time Frame: 17 weeks after start of treatment ]
  • Grass specific IgE [ Time Frame: 17 weeks after start of treatment ]
  • Area of Late Phase Skin Response [ Time Frame: 17 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: 17 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: 4 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: 8 weeks after start of treatment ]
  • Change in CPT score [ Time Frame: 12 weeks after start of treatment ]
Not Provided
Not Provided
 
Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis
An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.

ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.

This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy of ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 6 weeks before randomisation.

Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The first cohort will receive the lowest dose and successive dose groups will increasing doses of ToleroMune Grass, provided the first administration of the previous dose was safe and well tolerated.

In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks after the last administration in the Treatment Period and the second will be 17 weeks after the first administration. Follow-up will be conducted 3-10 days after the second PTC.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergy
  • Biological: Placebo
    Solution resembling active solution but without peptides
  • Biological: ToleroMune Grass
    1 x4 administrations 4 weeks apart
  • Experimental: Cohort 1
    Subjects to receive either active or placebo
    Interventions:
    • Biological: Placebo
    • Biological: ToleroMune Grass
  • Experimental: Cohort 2
    Subjects to receive either active or placebo comparator
    Interventions:
    • Biological: Placebo
    • Biological: ToleroMune Grass
  • Experimental: Cohort 3
    Subjects to receive either active or placebo comparator
    Interventions:
    • Biological: Placebo
    • Biological: ToleroMune Grass
  • Experimental: Cohort 4
    Subjects to receive either active or placebo comparator
    Interventions:
    • Biological: Placebo
    • Biological: ToleroMune Grass
  • Experimental: Cohort 5
    Subjects to receive either active or placebo comparator
    Interventions:
    • Biological: Placebo
    • Biological: ToleroMune Grass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
April 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, aged 18-65 years
  • Minimum 2 year history of rhinoconjunctivitis on exposure to grass
  • Positive skin prick test to whole grass allergen
  • LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
  • Positive CPT to whole grass allergen with a score ≥4

Exclusion Criteria:

  • Subjects with a history of asthma
  • Subjects with an FEV1 <80% of predicted
  • Subjects with a rye grass specific IgE >100 kU/L
  • Subjects with an acute phase skin response to whole grass 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, tranquillisers 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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01166061
TG001
No
Not Provided
Not Provided
Dr Rod Hafner, VP R&D, Circassia Ltd
Circassia Limited
Adiga Life Sciences, Inc.
Principal Investigator: Jacques Hebert, MD Centre de recherche appliquée en allergie de Quebec
Circassia Limited
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP