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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	May 20, 2011
Last Verified:	May 2011

Keywords provided by Circassia Limited:

Grass Allergy; Immunotherapy; Rhinoconjunctivitis; ToleroMune Grass