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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Adiga Life Sciences
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT02061709
First received: February 3, 2014
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Biological: Ragweed-SPIRE
Biological: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) [ Time Frame: Between Baseline and approximately 25 weeks after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints [ Time Frame: Between Baseline and approximately 25 weeks after randomisation ] [ Designated as safety issue: No ]
  • Change from Baseline in mean Total Nasal Symptom Score (TNSS) [ Time Frame: Aproximately 25 weeks after randomisation ] [ Designated as safety issue: No ]
  • Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS) [ Time Frame: Approximately 25 weeks after randomisation ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: Approximately 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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.
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061709

Locations
Canada, Ontario
Kanata Allergy Services
Kanata, Ontario, Canada, K2L 3C8
KGK Synergize Inc
London, Ontario, Canada, N6A 5R8
Inflamax Research
Mississauga, Ontario, Canada, L8P 0A1
Taunton Health Centre
Oshawa, Ontario, Canada, L1H 7K4
Windsor Allergy Asthma Associates
Windsor, Ontario, Canada, N8X 2G1
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences
Investigators
Principal Investigator: Piyush Patel, MD Inflamax Research
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT02061709     History of Changes
Other Study ID Numbers: TR006
Study First Received: February 3, 2014
Last Updated: May 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by Circassia Limited:
Rhinoconjunctivitis
Rhinitis
Seasonal
Ragweed
Allergy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014