NCT02396680

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 19, 2015

Last Update Submit

March 22, 2016

Conditions

RhinoconjunctivitisRagweed Allergy

Keywords

Ragweed AllergyRhinoconjunctivitisImmunotherapyRagweed-SPIRE

Outcome Measures

Primary Outcomes (1)

  • Total Rhinoconjunctivitis Symptom Score

    Approximately 12 months after first dose in TR006

Secondary Outcomes (4)

  • Rescue Medication Score

    Approximately 12 months after first dose in TR006

  • Patient Global Assessment

    Approximately 12 months after first dose in TR006

  • Skin Prick Test

    Approximately 12 months after first dose in TR006

  • Immunoglobulin E Test

    Approximately 12 months after first dose in TR006

Study Arms (1)

TR006 Subjects

Subjects that have previously been randomised into study TR006

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who completed at least 6 of 8 treatment visits in Study TR006

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kanata Allergy Services

Kanata, Ontario, K2L 3C8, Canada

Location

Inflamax Research

Mississauga, Ontario, Canada

Location

Windsor Allergy Asthma Associates

Windsor, Ontario, N8X 2G1, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 24, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

CA(3)