Overview

This trial has been completed.

Condition rhinitis
Treatments birch-spire, placebo
Phase phase 2
Sponsor Circassia Limited
Collaborator Adiga Life Sciences, Inc.
Start date July 2015
End date July 2016
Trial size 64 participants
Trial identifier NCT02478060, CB001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Birch-SPIRE or placebo, 2 weeks apart
birch-spire
placebo
(Experimental)
Birch-SPIRE or placebo, 2 weeks apart
birch-spire
placebo
(Experimental)
Birch-SPIRE or placebo, 2 weeks apart
birch-spire
placebo
(Experimental)
Birch-SPIRE or placebo, 2 weeks apart
birch-spire
placebo
(Experimental)
Birch-SPIRE or placebo, 2 weeks apart
birch-spire
placebo

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Circassia Limited.