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Completed

NCT Number: NCT02396680

Ragweed-SPIRE Follow-On Study

The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.

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Key information

Conditions

Rhinoconjunctivitis Ragweed Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

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

° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006

Exclusion criteria

  • Subject or Investigator have been informed of treatment received in Study TR006
  • Subjects with significant allergy to animal dander
  • Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies
  • History of recurrent acute sinusitis or chronic sinusitis
  • Received treatment with an investigational drug within 4 weeks of Screening
  • Unable to understand study requirements or unable to communicate clearly with Investigator

Treatment and study plan

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Score

    Time frame: Approximately 12 months after first dose in TR006

Secondary outcomes

  1. Rescue Medication Score

    Time frame: Approximately 12 months after first dose in TR006

  2. Patient Global Assessment

    Time frame: Approximately 12 months after first dose in TR006

  3. Skin Prick Test

    Time frame: Approximately 12 months after first dose in TR006

  4. Immunoglobulin E Test

    Time frame: Approximately 12 months after first dose in TR006

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.

Registry information

Official study title

An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment

Important dates

Study start
2015
Primary completion
2016
First posted
Mar 24, 2015
Registry last updated
Mar 23, 2016

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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