Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate Three Dose Regimens of Ragweed-SPIRE in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber

The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Biological: Placebo; Biological: Ragweed-SPIRE

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kanata, Ontario, Canada, K2L 3C8
      • Kanata Allergy Services
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc
    • Mississauga, Ontario, Canada, L8P 0A1
      • Inflamax Research
    • Oshawa, Ontario, Canada, L1H 7K4
      • Taunton Health Centre
    • Windsor, Ontario, Canada, N8X 2G1
      • Windsor Allergy Asthma Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 18-65 years.
• Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
• Minimum qualifying rhinoconjunctivitis symptom scores
• Ragweed-specific Immunoglobulin E (IgE) > 0.70 kU/L.

Exclusion Criteria:

• Subjects with a history of ragweed pollen induced asthma
• A history of anaphylaxis to ragweed allergen.
• FEV1 < 80 % of predicted.
• Subjects who cannot tolerate Baseline Challenge in the EEC.
• Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
• History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ragweed-SPIRE 1; Ragweed SPIRE regimen 1 given 2 weeks apart	Biological: Ragweed-SPIRE
Experimental: Ragweed-SPIRE 2; Ragweed-SPIRE regimen 2 given 2 weeks apart	Biological: Ragweed-SPIRE
Experimental: Ragweed-SPIRE 3; Ragweed-SPIRE regimen 3 given 2 weeks apart	Biological: Ragweed-SPIRE
Placebo Comparator: Placebo; Placebo given 2 weeks apart	Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)	Between Baseline and approximately 25 weeks after randomisation

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints	Between Baseline and approximately 25 weeks after randomisation
Change from Baseline in mean Total Nasal Symptom Score (TNSS)	Aproximately 25 weeks after randomisation
Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)	Approximately 25 weeks after randomisation
Number of Participants with Adverse Events as a Measure of Safety and tolerability	Approximately 28 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Adiga Life Sciences, Inc.
• Investigators: Principal Investigator: Piyush Patel, MD, Inflamax Research

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Allergy; Seasonal; Rhinoconjunctivitis; Rhinitis; Ragweed
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: TR006