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

May 19, 2011 updated by: Circassia Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4M6
        • Centre de Recherche Appliqué en Allergie de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis
Time Frame: Upto 22 weeks
Upto 22 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Area of Late Phase Skin Response
Time Frame: Baseline and 14 weeks
Baseline and 14 weeks
Area of Early Phase Skin Response
Time Frame: Baseline and 14 weeks
Baseline and 14 weeks
Change in CPT score
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Grass specific IgG4
Time Frame: Baseline and 14 weeks
Baseline and 14 weeks
Change in CPT score
Time Frame: Baseline and 14 weeks
Baseline and 14 weeks
Area of Early Phase Skin Response
Time Frame: Baseline and 17 weeks
Baseline and 17 weeks
Grass specific IgE
Time Frame: Baseline and 17 weeks
Baseline and 17 weeks
Area of Late Phase Skin Response
Time Frame: Baseline and 17 weeks
Baseline and 17 weeks
Change in CPT score
Time Frame: 17 weeks after start of treatment
17 weeks after start of treatment
Change in CPT score
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Change in CPT score
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Grass specific IgE
Time Frame: Baseline and 14 weeks
Baseline and 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Adiga Life Sciences, Inc.

Investigators

  • Principal Investigator: Jacques Hebert, MD, Centre De Recherche Appliquée en Allergie De Québec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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