ToleroMune Grass Follow on Study
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.
1 other identifier
observational
84
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedNovember 17, 2014
November 1, 2014
5 months
November 13, 2014
November 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Rhinoconjunctivitis Symptom Scores
32 months post first dose in TG002
Secondary Outcomes (5)
Grass Specific Immunoglobulin A (IgA)
32 months post first dose in TG002
Grass Specific Immunoglobulin E (IgE)
32 months post first dose in TG002
Grass Specific Immunoglobulin G Isotype 4 (IgG4)
32 months post first dose in TG002
Skin Prick Weal Diameter
32 months post first dose in TG002
Adverse Events
32 months post first dose in TG002
Study Arms (1)
TG002 Subjects
Subjects previously randomised in study TG002
Eligibility Criteria
Subject previously randomised in study TG002 and completed all dosing visits and the PTC
You may qualify if:
- Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012
You may not qualify if:
- "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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Circassia Limitedlead
- Adiga Life Sciences, Inc.collaborator
Study Sites (2)
Unknown Facility
Kanata, Ontario, Canada
Unknown Facility
Kingston, Ontario, Canada
Related Publications (1)
Ellis AK, Frankish CW, Armstrong K, Steacy L, Tenn MW, Pawsey S, Hafner RP. Persistence of the clinical effect of grass allergen peptide immunotherapy after the second and third grass pollen seasons. J Allergy Clin Immunol. 2020 Feb;145(2):610-618.e9. doi: 10.1016/j.jaci.2019.09.010. Epub 2019 Sep 27.
PMID: 31568796DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 17, 2014
Study Start
April 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
November 17, 2014
Record last verified: 2014-11