NCT02061709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

February 3, 2014

Last Update Submit

March 19, 2015

Conditions

Seasonal Allergic Rhinitis

Keywords

RhinoconjunctivitisRhinitisSeasonalRagweedAllergy

Outcome Measures

Primary Outcomes (1)

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

    Between Baseline and approximately 25 weeks after randomisation

Secondary Outcomes (4)

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

    Between Baseline and approximately 25 weeks after randomisation

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

    Aproximately 25 weeks after randomisation

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

    Approximately 25 weeks after randomisation

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

    Approximately 28 weeks

Study Arms (4)

Ragweed-SPIRE 1

EXPERIMENTAL

Ragweed SPIRE regimen 1 given 2 weeks apart

Biological: Ragweed-SPIRE

Ragweed-SPIRE 2

EXPERIMENTAL

Ragweed-SPIRE regimen 2 given 2 weeks apart

Biological: Ragweed-SPIRE

Ragweed-SPIRE 3

EXPERIMENTAL

Ragweed-SPIRE regimen 3 given 2 weeks apart

Biological: Ragweed-SPIRE

Placebo

PLACEBO COMPARATOR

Placebo given 2 weeks apart

Biological: Placebo

Interventions

Ragweed-SPIREBIOLOGICAL
Ragweed-SPIRE 1Ragweed-SPIRE 2Ragweed-SPIRE 3
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kanata Allergy Services

Kanata, Ontario, K2L 3C8, Canada

Location

KGK Synergize Inc

London, Ontario, N6A 5R8, Canada

Location

Inflamax Research

Mississauga, Ontario, L8P 0A1, Canada

Location

Taunton Health Centre

Oshawa, Ontario, L1H 7K4, Canada

Location

Windsor Allergy Asthma Associates

Windsor, Ontario, N8X 2G1, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitisHypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, AllergicNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesRespiratory Tract InfectionsInfections

Study Officials

  • Piyush Patel, MD

    Inflamax Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 13, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

CA(5)