ToleroMune Grass Exposure Unit Study

This study has been completed.
Sponsor:
Collaborators:
Adiga Life Sciences
Pharm-Olam International
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01385800
First received: June 29, 2011
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Grass Allergy
Rhinoconjunctivitis
Biological: ToleroMune Grass
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Total Rhinoconjunctivitis Symptom Score [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom scores for nasal and non nasal symptoms [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]
  • Skin prick testing [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]
  • Peak Nasal Inspiratory Flow [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: No ]
  • Grass specific IgA [ Time Frame: Upto 26 weeks ] [ Designated as safety issue: No ]
  • Grass specific IgE [ Time Frame: Upto 26 weeks ] [ Designated as safety issue: No ]
  • Grass specific IgG4 [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Up tp 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Intradermal injection, 1 x 8 administrations 2 weeks apart
Biological: Placebo
Intradermal injection 1 x 8 administrations 2 weeks apart
Experimental: ToleroMune Grass Dose 1
Intradermal injection 1 x 8 administrations 2 weeks apart
Biological: ToleroMune Grass
Intradermal injection 1 x 8 administrations 2 weeks apart
Experimental: ToleroMune Grass Dose 2
Intradermal injection 1 x 8 administrations 2 weeks apart
Biological: ToleroMune Grass
Intradermal injection 1 x 8 administrations 2 weeks apart
Experimental: ToleroMune Grass Dose 3
Intradermal injection 1 x 8 administrations 2 weeks apart
Biological: ToleroMune Grass
Intradermal injection 1 x 8 administrations 2 weeks apart

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Male or female, aged 18-65 years.
  • Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass.
  • Positive skin prick test to grass allergen.
  • Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

  • History of asthma.
  • A history of anaphylaxis to grassallergen.
  • Subjects with an FEV1 <80% of predicted.
  • Subjects who cannot tolerate baseline challenge in the EEU.
  • Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
  • A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
  • A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/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: NCT01385800

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences
Pharm-Olam International
Investigators
Principal Investigator: Anne K Ellis, MD MSC FRCPC Queen's University, Kingston, Ontario
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01385800     History of Changes
Other Study ID Numbers: TG002
Study First Received: June 29, 2011
Last Updated: August 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Grass allergy
Rhinoconjunctivitis
Environmental Exposure Unit
Immunotherapy
ToleroMune Grass

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Rhinitis, Allergic, Seasonal
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 26, 2014