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

Allergy Clinical Trial

Official title:

An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166061
• Other study ID #: TG001
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2010
• Last updated: May 19, 2011
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• Placebo
Solution resembling active solution but without peptides
• ToleroMune Grass
1 x4 administrations 4 weeks apart

Locations

Country	Name	City	State
Canada	Centre de Recherche Appliqué en Allergie de Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis		Upto 22 weeks	Yes
Secondary	Area of Late Phase Skin Response		Baseline and 14 weeks	No
Secondary	Area of Early Phase Skin Response		Baseline and 14 weeks	No
Secondary	Change in CPT score		Baseline and 4 weeks	No
Secondary	Grass specific IgG4		Baseline and 14 weeks	No
Secondary	Change in CPT score		Baseline and 14 weeks	No
Secondary	Area of Early Phase Skin Response		Baseline and 17 weeks	No
Secondary	Grass specific IgE		Baseline and 17 weeks	No
Secondary	Area of Late Phase Skin Response		Baseline and 17 weeks	No
Secondary	Change in CPT score		17 weeks after start of treatment	No
Secondary	Change in CPT score		Baseline and 8 weeks	No
Secondary	Change in CPT score		Baseline and 12 weeks	No
Secondary	Grass specific IgE		Baseline and 14 weeks	No