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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ragweed-SPIRE
Placebo
Sponsored by
Circassia Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Rhinoconjunctivitis, Rhinitis, Seasonal, Ragweed, Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kanata Allergy Services
  • KGK Synergize Inc
  • Inflamax Research
  • Taunton Health Centre
  • Windsor Allergy Asthma Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Ragweed-SPIRE 1

Ragweed-SPIRE 2

Ragweed-SPIRE 3

Placebo

Arm Description

Ragweed SPIRE regimen 1 given 2 weeks apart

Ragweed-SPIRE regimen 2 given 2 weeks apart

Ragweed-SPIRE regimen 3 given 2 weeks apart

Placebo given 2 weeks apart

Outcomes

Primary Outcome Measures

Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)

Secondary Outcome Measures

Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints
Change from Baseline in mean Total Nasal Symptom Score (TNSS)
Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)
Number of Participants with Adverse Events as a Measure of Safety and tolerability

Full Information

First Posted
February 3, 2014
Last Updated
March 19, 2015
Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02061709
Brief Title
Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Rhinoconjunctivitis, Rhinitis, Seasonal, Ragweed, Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ragweed-SPIRE 1
Arm Type
Experimental
Arm Description
Ragweed SPIRE regimen 1 given 2 weeks apart
Arm Title
Ragweed-SPIRE 2
Arm Type
Experimental
Arm Description
Ragweed-SPIRE regimen 2 given 2 weeks apart
Arm Title
Ragweed-SPIRE 3
Arm Type
Experimental
Arm Description
Ragweed-SPIRE regimen 3 given 2 weeks apart
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given 2 weeks apart
Intervention Type
Biological
Intervention Name(s)
Ragweed-SPIRE
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)
Time Frame
Between Baseline and approximately 25 weeks after randomisation
Secondary Outcome Measure Information:
Title
Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints
Time Frame
Between Baseline and approximately 25 weeks after randomisation
Title
Change from Baseline in mean Total Nasal Symptom Score (TNSS)
Time Frame
Aproximately 25 weeks after randomisation
Title
Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)
Time Frame
Approximately 25 weeks after randomisation
Title
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time Frame
Approximately 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piyush Patel, MD
Organizational Affiliation
Inflamax Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanata Allergy Services
City
Kanata
State/Province
Ontario
ZIP/Postal Code
K2L 3C8
Country
Canada
Facility Name
KGK Synergize Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada
Facility Name
Inflamax Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L8P 0A1
Country
Canada
Facility Name
Taunton Health Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
Windsor Allergy Asthma Associates
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada

12. IPD Sharing Statement

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

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