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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

June 29, 2011
August 14, 2013
August 2011
July 2013   (final data collection date for primary outcome measure)
Total Rhinoconjunctivitis Symptom Score [ Time Frame: Upto 25 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01385800 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
ToleroMune Grass Exposure Unit Study
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Grass Allergy
  • Rhinoconjunctivitis
  • Biological: ToleroMune Grass
    Intradermal injection 1 x 8 administrations 2 weeks apart
  • Biological: Placebo
    Intradermal injection 1 x 8 administrations 2 weeks apart
  • Placebo Comparator: Placebo
    Intradermal injection, 1 x 8 administrations 2 weeks apart
    Intervention: Biological: Placebo
  • Experimental: ToleroMune Grass Dose 1
    Intradermal injection 1 x 8 administrations 2 weeks apart
    Intervention: Biological: ToleroMune Grass
  • Experimental: ToleroMune Grass Dose 2
    Intradermal injection 1 x 8 administrations 2 weeks apart
    Intervention: Biological: ToleroMune Grass
  • Experimental: ToleroMune Grass Dose 3
    Intradermal injection 1 x 8 administrations 2 weeks apart
    Intervention: Biological: ToleroMune Grass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
August 2013
July 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01385800
TG002
No
Circassia Limited
Circassia Limited
  • Adiga Life Sciences
  • Pharm-Olam International
Principal Investigator: Anne K Ellis, MD MSC FRCPC Queen's University, Kingston, Ontario
Circassia Limited
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP