Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis - Full Text View

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 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

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 ]

Secondary Outcome Measures:

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 ]


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)
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

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

Keywords provided by Circassia Limited:


Grass Allergy Immunotherapy Rhinoconjunctivitis ToleroMune Grass

ClinicalTrials.gov processed this record on August 18, 2017