ToleroMune Grass Exposure Unit Study

Phase 2

Completed

• Conditions: Grass Allergy; Rhinoconjunctivitis
• Interventions: Biological: Placebo; Biological: ToleroMune Grass

• Registration Number: NCT01385800
• Lead Sponsor: Circassia Limited

Brief Summary

Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised 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.

This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).

Detailed Description

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in subjects using an EEU (Environmental Exposure Unit).

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEU at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEU about 25 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Study Timeline

• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-08
• Primary Completion: 2013-07
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intradermal injection, 1 x 8 administrations 2 weeks apart
ToleroMune Grass Dose 1	ToleroMune Grass	Intradermal injection 1 x 8 administrations 2 weeks apart
ToleroMune Grass Dose 2	ToleroMune Grass	Intradermal injection 1 x 8 administrations 2 weeks apart
ToleroMune Grass Dose 3	ToleroMune Grass	Intradermal injection 1 x 8 administrations 2 weeks apart

Primary Outcome Measures

Name	Time	Method
Total Rhinoconjunctivitis Symptom Score	Upto 25 weeks

Secondary Outcome Measures

Name	Time	Method
Symptom scores for nasal and non nasal symptoms	Upto 25 weeks
Skin prick testing	Upto 25 weeks
Peak Nasal Inspiratory Flow	Up to 25 weeks
Grass specific IgA	Upto 26 weeks
Grass specific IgE	Upto 26 weeks
Grass specific IgG4	Up to 26 weeks
Adverse Events	Up tp 26 weeks

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada