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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

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Allergy Biological: Placebo Biological: ToleroMune Grass 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 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass
Study Start Date : July 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Subjects to receive either active or placebo
 Biological: Placebo
Solution resembling active solution but without peptides

Biological: ToleroMune Grass
1 x4 administrations 4 weeks apart
Experimental: Cohort 2
Subjects to receive either active or placebo comparator
 Biological: Placebo
Solution resembling active solution but without peptides

Biological: ToleroMune Grass
1 x4 administrations 4 weeks apart
Experimental: Cohort 3
Subjects to receive either active or placebo comparator
 Biological: Placebo
Solution resembling active solution but without peptides

Biological: ToleroMune Grass
1 x4 administrations 4 weeks apart
Experimental: Cohort 4
Subjects to receive either active or placebo comparator
 Biological: Placebo
Solution resembling active solution but without peptides

Biological: ToleroMune Grass
1 x4 administrations 4 weeks apart
Experimental: Cohort 5
Subjects to receive either active or placebo comparator
 Biological: Placebo
Solution resembling active solution but without peptides

Biological: ToleroMune Grass
1 x4 administrations 4 weeks apart


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

Secondary Outcome Measures :
  1. Area of Late Phase Skin Response [ Time Frame: Baseline and 14 weeks ]
  2. Area of Early Phase Skin Response [ Time Frame: Baseline and 14 weeks ]
  3. Change in CPT score [ Time Frame: Baseline and 4 weeks ]
  4. Grass specific IgG4 [ Time Frame: Baseline and 14 weeks ]
  5. Change in CPT score [ Time Frame: Baseline and 14 weeks ]
  6. Area of Early Phase Skin Response [ Time Frame: Baseline and 17 weeks ]
  7. Grass specific IgE [ Time Frame: Baseline and 17 weeks ]
  8. Area of Late Phase Skin Response [ Time Frame: Baseline and 17 weeks ]
  9. Change in CPT score [ Time Frame: 17 weeks after start of treatment ]
  10. Change in CPT score [ Time Frame: Baseline and 8 weeks ]
  11. Change in CPT score [ Time Frame: Baseline and 12 weeks ]
  12. Grass specific IgE [ Time Frame: Baseline and 14 weeks ]

Eligibility Criteria
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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
  • 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)
Contacts and Locations
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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): NCT01166061


Locations
Canada
Centre de Recherche Appliqué en Allergie de Québec
Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.
Investigators
Principal Investigator: Jacques Hebert, MD Centre de recherche appliquée en allergie de Quebec
More Information
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Responsible Party: Dr Rod Hafner, VP R&D, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01166061     History of Changes
Other Study ID Numbers: TG001
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

Keywords provided by Circassia Limited:
Grass Allergy
Immunotherapy
Rhinoconjunctivitis
ToleroMune Grass