search
Back to results

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

Primary Purpose

Allergy

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Placebo
ToleroMune Grass
Sponsored by
Circassia Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring Grass Allergy, Immunotherapy, Rhinoconjunctivitis, ToleroMune Grass

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre de Recherche Appliqué en Allergie de Québec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Subjects to receive either active or placebo

Subjects to receive either active or placebo comparator

Subjects to receive either active or placebo comparator

Subjects to receive either active or placebo comparator

Subjects to receive either active or placebo comparator

Outcomes

Primary Outcome Measures

Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis

Secondary Outcome Measures

Area of Late Phase Skin Response
Area of Early Phase Skin Response
Change in CPT score
Grass specific IgG4
Change in CPT score
Area of Early Phase Skin Response
Grass specific IgE
Area of Late Phase Skin Response
Change in CPT score
Change in CPT score
Change in CPT score
Grass specific IgE

Full Information

First Posted
July 8, 2010
Last Updated
May 19, 2011
Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01166061
Brief Title
Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis
Official Title
An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Grass Allergy, Immunotherapy, Rhinoconjunctivitis, ToleroMune Grass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects to receive either active or placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects to receive either active or placebo comparator
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subjects to receive either active or placebo comparator
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Subjects to receive either active or placebo comparator
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Subjects to receive either active or placebo comparator
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution resembling active solution but without peptides
Intervention Type
Biological
Intervention Name(s)
ToleroMune Grass
Intervention Description
1 x4 administrations 4 weeks apart
Primary Outcome Measure Information:
Title
Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis
Time Frame
Upto 22 weeks
Secondary Outcome Measure Information:
Title
Area of Late Phase Skin Response
Time Frame
Baseline and 14 weeks
Title
Area of Early Phase Skin Response
Time Frame
Baseline and 14 weeks
Title
Change in CPT score
Time Frame
Baseline and 4 weeks
Title
Grass specific IgG4
Time Frame
Baseline and 14 weeks
Title
Change in CPT score
Time Frame
Baseline and 14 weeks
Title
Area of Early Phase Skin Response
Time Frame
Baseline and 17 weeks
Title
Grass specific IgE
Time Frame
Baseline and 17 weeks
Title
Area of Late Phase Skin Response
Time Frame
Baseline and 17 weeks
Title
Change in CPT score
Time Frame
17 weeks after start of treatment
Title
Change in CPT score
Time Frame
Baseline and 8 weeks
Title
Change in CPT score
Time Frame
Baseline and 12 weeks
Title
Grass specific IgE
Time Frame
Baseline and 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Hebert, MD
Organizational Affiliation
Centre de recherche appliquée en allergie de Quebec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Appliqué en Allergie de Québec
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs