Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02061709

Enrollment

280

Registered

2014-02-13

Start date

2014-01-31

Completion date

2014-10-31

Last updated

2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Rhinoconjunctivitis, Rhinitis, Seasonal, Ragweed, Allergy

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

Interventions

BIOLOGICALRagweed-SPIRE

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change from Baseline in mean Total Rhinoconjunctivitis Symptom Score (TRSS)	Between Baseline and approximately 25 weeks after randomisation

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026