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ToleroMune Grass Exposure Unit Study

NCT01385800 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2013-08-15

No results posted yet for this study

Summary

Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).

Conditions

  • Grass Allergy
  • Rhinoconjunctivitis

Interventions

BIOLOGICAL

ToleroMune Grass

Intradermal injection 1 x 8 administrations 2 weeks apart

BIOLOGICAL

Placebo

Intradermal injection 1 x 8 administrations 2 weeks apart

Sponsors & Collaborators

  • Adiga Life Sciences, Inc.

    collaborator INDUSTRY

  • Pharm-Olam International

    collaborator INDUSTRY

  • Circassia Limited

    lead INDUSTRY

Principal Investigators

  • Anne K Ellis, MD MSC FRCPC · Queen's University, Kingston, Ontario

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
2011-08-31
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT01385800 on ClinicalTrials.gov