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

This study has been completed.
Sponsor:
Collaborator:
Adiga Life Sciences, Inc.
Information provided by:
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01166061
First received: July 8, 2010
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Allergy
 Biological: Placebo
Biological: ToleroMune Grass
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis [ Time Frame: Upto 22 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area of Late Phase Skin Response [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Area of Early Phase Skin Response [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Change in CPT score [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Grass specific IgG4 [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Change in CPT score [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
  • Area of Early Phase Skin Response [ Time Frame: Baseline and 17 weeks ] [ Designated as safety issue: No ]
  • Grass specific IgE [ Time Frame: Baseline and 17 weeks ] [ Designated as safety issue: No ]
  • Area of Late Phase Skin Response [ Time Frame: Baseline and 17 weeks ] [ Designated as safety issue: No ]
  • Change in CPT score [ Time Frame: 17 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Change in CPT score [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change in CPT score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Grass specific IgE [ Time Frame: Baseline and 14 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 50
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
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: 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

Responsible Party: Dr Rod Hafner, VP R&D, Circassia Ltd
ClinicalTrials.gov Identifier: NCT01166061     History of Changes
Other Study ID Numbers: TG001 
Study First Received: July 8, 2010
Last Updated: May 19, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016