Ragweed-SPIRE Follow-On Study

Sponsor

Circassia Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT02396680

Collaborator

Adiga Life Sciences, Inc. (Industry)

249

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rhinoconjunctivitis Ragweed Allergy

Study Design

Study Type:

Observational

Actual Enrollment :

249 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
TR006 Subjects Subjects that have previously been randomised into study TR006

Outcome Measures

Primary Outcome Measures

Total Rhinoconjunctivitis Symptom Score [Approximately 12 months after first dose in TR006]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanata Allergy Services	Kanata	Ontario	Canada	K2L 3C8
2	Inflamax Research	Mississauga	Ontario	Canada
3	Windsor Allergy Asthma Associates	Windsor	Ontario	Canada	N8X 2G1