Birch-SPIRE Safety and Efficacy Study

A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02478060

Enrollment

Registered

2015-06-23

Start date

2015-07-31

Completion date

Unknown

Last updated

2016-11-08

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

Conditions

Rhinitis

Keywords

Allergy, Birch, Rhinitis, Rhinoconjuntivitis, SPIRE, Toleromune

Brief summary

The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.

Interventions

BIOLOGICALBirch-SPIRE

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female, aged 18 to 65 years; * Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen * Birch IgE ≥ 0.35 kU/L * Positive skin prick test to whole birch allergen

Exclusion criteria

* Any past history of asthma * FEV1 \< 80% of predicted * History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food * Acute phase skin response to whole birch allergen with a mean wheal diameter \> 50mm * Administration of adrenaline (epinephrine) is contraindicated * History of severe drug allergy or anaphylactic reaction to food. * History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Design outcomes

Primary

Measure	Time frame
Safety of Birch-SPIRE administrations measured by Adverse Events	Up to 16 weeks after start of dosing

Secondary

Measure	Time frame
Measurement of IgE as a Pharmacodynamic parameter	Up to 9 months after start of dosing
Conjunctival Provocation Test as a Pharmacodynamic parameter	Up to 9 months after start of dosing
Skin Prick Testing as a Pharmacodynamic parameter	Up to 9 months after start of dosing

Other

Measure	Time frame
Allergy symptoms and allergy medication use during next Birch season	Up to 9 months after start of dosing

Countries

Canada

Outcome results

None listed

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