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Birch-SPIRE Safety and Efficacy Study

NCT ID: NCT02478060

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rhinitis

Keywords

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Allergy Birch Rhinitis Rhinoconjuntivitis SPIRE Toleromune

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

Birch-SPIRE or placebo, 2 weeks apart

Group Type EXPERIMENTAL

Birch-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 2

Birch-SPIRE or placebo, 2 weeks apart

Group Type EXPERIMENTAL

Birch-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 3

Birch-SPIRE or placebo, 2 weeks apart

Group Type EXPERIMENTAL

Birch-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 4

Birch-SPIRE or placebo, 2 weeks apart

Group Type EXPERIMENTAL

Birch-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Cohort 5

Birch-SPIRE or placebo, 2 weeks apart

Group Type EXPERIMENTAL

Birch-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Interventions

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Birch-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adiga Life Sciences, Inc.

INDUSTRY

Sponsor Role collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de Recherche Appliqué en Allergie de Québec

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CB001

Identifier Type: -

Identifier Source: org_study_id