ToleroMune Grass Follow on Study

November 25, 2013 updated by: Circassia Limited

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject previously randomised in study TG002 and completed all dosing visits and the PTC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
TG002 Subjects
Subjects previously randomised in study TG002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Rhinoconjunctivitis Symptom Score
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom scores for nasal and non nasal symptoms
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002
Skin prick wheal diameter
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002
Peak Nasal Inspiratory Flow
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002
Grass specific IgA
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002
Grass specific IgE
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002
Grass specific IgG4
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002
Adverse Events
Time Frame: Eighteen months post first dose in TG002
Eighteen months post first dose in TG002

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

Adiga Life Sciences, Inc.
Pharm-Olam International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG002a

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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