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ToleroMune Grass Follow on Study

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ClinicalTrials.gov Identifier: NCT02292875
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Collaborator:
Adiga Life Sciences, Inc.
Information provided by (Responsible Party):
Circassia Limited

Brief 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.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately two years after the start of treatment.


Condition or disease
Rhinoconjunctivitis Grass Allergy

Detailed Description:
This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who completed TG002 in calendar year 2012 will undergo a further single exposure to grass allergens in an EEU.

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit.
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Group/Cohort
TG002 Subjects
Subjects previously randomised in study TG002



Primary Outcome Measures :
  1. Total Rhinoconjunctivitis Symptom Scores [ Time Frame: 32 months post first dose in TG002 ]

Secondary Outcome Measures :
  1. Grass Specific Immunoglobulin A (IgA) [ Time Frame: 32 months post first dose in TG002 ]
  2. Grass Specific Immunoglobulin E (IgE) [ Time Frame: 32 months post first dose in TG002 ]
  3. Grass Specific Immunoglobulin G Isotype 4 (IgG4) [ Time Frame: 32 months post first dose in TG002 ]
  4. Skin Prick Weal Diameter [ Time Frame: 32 months post first dose in TG002 ]
  5. Adverse Events [ Time Frame: 32 months post first dose in TG002 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject previously randomised in study TG002 and completed all dosing visits and the PTC
Criteria

Inclusion Criteria:

  • Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012

Exclusion Criteria:

  • "Partly controlled" and "uncontrolled" asthama
  • History of anaphylaxis to grass allergen
  • FEV1 <80% of predicted
  • Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs
  • Symptoms of a clinically relevant illness
  • Subjects who cannot tolerate allergen challenge in the EEU

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292875


Locations
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Canada, Ontario
Kanata, Ontario, Canada
Kingston, Ontario, Canada
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT02292875    
Other Study ID Numbers: TG002B
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Keywords provided by Circassia Limited:
Grass Allergy
Rhinoconjunctivitis
Environmental Exposure Unit
Immunotherapy
ToleroMune Grass
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases