Status:
COMPLETED
ToleroMune Ragweed Exposure Chamber Study
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
Adiga Life Sciences, Inc.
Cetero Research, San Antonio
Conditions:
Ragweed Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 pept...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT01198613
Start Date
September 1 2010
End Date
August 1 2011
Last Update
October 7 2011
Active Locations (2)
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1
KGK Synergize Inc.
London, Ontario, Canada, ON N6A 5R8
2
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2