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
163
0 countries
N/A
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 one year 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 May 2013
Shorter than P25 for all trials
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
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedNovember 26, 2013
November 1, 2013
3 months
July 16, 2013
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Rhinoconjunctivitis Symptom Score
Eighteen months post first dose in TG002
Secondary Outcomes (7)
Symptom scores for nasal and non nasal symptoms
Eighteen months post first dose in TG002
Skin prick wheal diameter
Eighteen months post first dose in TG002
Peak Nasal Inspiratory Flow
Eighteen months post first dose in TG002
Grass specific IgA
Eighteen months post first dose in TG002
Grass specific IgE
Eighteen months post first dose in TG002
- +2 more secondary outcomes
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, completed all treatment visits and PTC during calendar year 2012.
You may not qualify if:
- "Partly controlled" and "uncontrolled" asthma
- History of anaphylaxis to grass allergen
- FEV1 \<80% of predicted.
- Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactive drugs
- Symptoms of a clinically relevant illness
- Subjects who cannot tolerate allergen challenge in the EEC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Circassia Limitedlead
- Adiga Life Sciences, Inc.collaborator
- Pharm-Olam Internationalcollaborator
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
July 16, 2013
First Posted
August 16, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
November 26, 2013
Record last verified: 2013-11