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Completed

NCT Number: NCT02061709

Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to 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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kanata Allergy Services, Kanata, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ragweed-SPIRE

Biological

Placebo

Biological

Primary outcomes

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

    Time frame: Between Baseline and approximately 25 weeks after randomisation

Secondary outcomes

  1. Change from baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS) - all timepoints

    Time frame: Between Baseline and approximately 25 weeks after randomisation

  2. Change from Baseline in mean Total Nasal Symptom Score (TNSS)

    Time frame: Aproximately 25 weeks after randomisation

  3. Change from Baseline in mean Total Non Nasal Symptom Scores (TNNSS)

    Time frame: Approximately 25 weeks after randomisation

  4. Number of Participants with Adverse Events as a Measure of Safety and tolerability

    Time frame: Approximately 28 weeks

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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