Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02061670

Enrollment

Registered

2014-02-13

Start date

2014-01-31

Completion date

2014-10-31

Last updated

2015-01-21

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

Conditions

Asthma, Seasonal Allergic Rhinitis

Keywords

Ragweed, Allergy, rhinoconjunctivitis, rhinitis, asthma

Brief summary

The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.

Interventions

BIOLOGICALRagweed-SPIRE

Intradermal injection

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. * Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation. * A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons. * Positive skin prick test to ragweed * Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L.

Exclusion criteria

* History of life-threatening asthma. * Uncontrolled asthma according to GINA * FEV1 of \< 70 % of predicted, regardless of the cause. * Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). * History of severe drug allergy or anaphylactic reaction to food. * A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 22 weeks

Secondary

Measure	Time frame
Number of subjects with asthma exacerbations as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 22 weeks
Evaluation of change in lung function as a measure of safety and tolerability	Throughout subjects participation in the study, approximately 22 weeks

Countries

Canada

Outcome results

None listed

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