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Safety of ToleroMune Ragweed to Treat Ragweed Allergy in Ragweed Allergic Subjects With Rhinoconjunctivitis

NCT00878774 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-11-10

No results posted yet for this study

Summary

It is estimated that 36 million Americans suffer from seasonal allergies and that ragweed is the primary cause of autumn allergies, 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.

The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Ragweed in subjects in subjects with a documented history of allergic rhinoconjunctivitis on exposure to ragweed pollen. The efficacy of ToleroMune Ragweed will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin Response and Conjunctival Provocation Test.

Conditions

  • Allergy

Interventions

BIOLOGICAL

ToleroMune Ragweed

ToleroMune Ragweed dose 1x4 administrations 2 weeks apart

BIOLOGICAL

Placebo

Placebo comparator, 1x4 administrations 2 weeks apart

Sponsors & Collaborators

  • Adiga Life Sciences, Inc.

    collaborator INDUSTRY

  • Circassia Limited

    lead INDUSTRY

Principal Investigators

  • Jacques Hebert, MD · Centre de Recherche Appliqué en Allergie de Québec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878774 on ClinicalTrials.gov