Birch-SPIRE Safety and Efficacy Study

November 7, 2016 updated by: Circassia Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4M6
        • Centre de Recherche Appliqué en Allergie de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Birch-SPIRE or placebo, 2 weeks apart
Biological: Placebo
Biological: Birch-SPIRE
Experimental: Cohort 2
Birch-SPIRE or placebo, 2 weeks apart
Biological: Placebo
Biological: Birch-SPIRE
Experimental: Cohort 3
Birch-SPIRE or placebo, 2 weeks apart
Biological: Placebo
Biological: Birch-SPIRE
Experimental: Cohort 4
Birch-SPIRE or placebo, 2 weeks apart
Biological: Placebo
Biological: Birch-SPIRE
Experimental: Cohort 5
Birch-SPIRE or placebo, 2 weeks apart
Biological: Placebo
Biological: Birch-SPIRE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of IgE as a Pharmacodynamic parameter
Time Frame: Up to 9 months after start of dosing
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
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
Up to 9 months after start of dosing

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Quintiles, Inc.
Adiga Life Sciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rhinitis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe