ToleroMune Grass Follow on Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ToleroMune Grass Follow on Study

NCT02292875

Rhinoconjunctivitis Grass Allergy

COMPLETED

ToleroMune Grass Exposure Unit Study

NCT01385800

Grass Allergy Rhinoconjunctivitis

COMPLETED PHASE2

Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis

NCT01166061

Allergy

COMPLETED PHASE2

ToleroMune Ragweed Follow up Study

NCT01448603

Ragweed Allergy Rhinoconjunctivitis

COMPLETED

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

NCT00878774

Allergy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Grass Allergy Rhinoconjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TG002 Subjects

Subjects previously randomised in study TG002

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* "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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No