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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061709
• Other study ID #: TR006
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2014
• Last updated: March 19, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Biological:
• Ragweed-SPIRE

• Placebo

Locations

Country	Name	City	State
Canada	Kanata Allergy Services	Kanata	Ontario
Canada	KGK Synergize Inc	London	Ontario
Canada	Inflamax Research	Mississauga	Ontario
Canada	Taunton Health Centre	Oshawa	Ontario
Canada	Windsor Allergy Asthma Associates	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)		Between Baseline and approximately 25 weeks after randomisation	No
Secondary	Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints		Between Baseline and approximately 25 weeks after randomisation	No
Secondary	Change from Baseline in mean Total Nasal Symptom Score (TNSS)		Aproximately 25 weeks after randomisation	No
Secondary	Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)		Approximately 25 weeks after randomisation	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and tolerability		Approximately 28 weeks	Yes