ToleroMune Ragweed Exposure Chamber Study - Full Text View

Purpose

It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.

This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

Condition	Intervention	Phase
Ragweed Allergy	Biological: ToleroMune Ragweed 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 Two Doses of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Circassia Limited:

Primary Outcome Measures:

Total Rhinoconjunctivitis Symptom Score [ Time Frame: Upto 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptom scores for ocular and nasal symptoms [ Time Frame: Upto 22 weeks ] [ Designated as safety issue: No ]
Acoustic Rhinometry [ Time Frame: Upto 22 weeks ] [ Designated as safety issue: No ]
Skin prick testing [ Time Frame: Baseline and final follow up ] [ Designated as safety issue: No ]
Ragweed specific IgE [ Time Frame: At baseline and at follow up ] [ Designated as safety issue: No ]
Ragweed specific IgA [ Time Frame: At baseline and follow up ] [ Designated as safety issue: No ]
Ragweed specific IgG4 [ Time Frame: At baseline and at follow up ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Upto 23 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	275
Study Start Date:	September 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Biological: Placebo Intradermal injection, 1x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 1	Biological: ToleroMune Ragweed Intradermal injection 1 x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 2	Biological: ToleroMune Ragweed Intradermal injection 1 x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 3	Biological: ToleroMune Ragweed Intradermal injection 1 x8 administrations 2 weeks apart
Experimental: ToleroMune Ragweed Regimen 4	Biological: ToleroMune Ragweed Intradermal injection 1 x8 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 Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 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 EEC 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 five 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 EEC 18-22 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 ragweed. [Subjects may also have controlled asthma
Positive skin prick test to ragweed allergen.
Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

History of asthma.
A history of anaphylaxis to ragweed allergen.
Subjects with an FEV1 <70% of predicted.
Subjects who cannot tolerate baseline challenge in the EEC.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198613

Locations

Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, ON N6A 5R8
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2

Sponsors and Collaborators

Circassia Limited

Adiga Life Sciences

Cetero Research, San Antonio

Investigators

Principal Investigator:

Deepen Patel, MD, CCFP

Cetero Research, San Antonio

More Information

No publications provided

Responsible Party:	Circassia Limited
ClinicalTrials.gov Identifier:	NCT01198613 History of Changes
Other Study ID Numbers:	TR002
Study First Received:	September 6, 2010
Last Updated:	October 6, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Circassia Limited:

Ragweed allergy
Rhinoconjunctivitis
Exposure chamber
Immunotherapy
ToleroMune Ragweed

Additional relevant MeSH terms:

Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases

Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 19, 2013