ToleroMune Grass Follow on Study

Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923779
• Other study ID #: TG002a
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: November 25, 2013
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• Grass Allergy
• Rhinoconjunctivitis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc., Pharm-Olam International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Rhinoconjunctivitis Symptom Score		Eighteen months post first dose in TG002	No
Secondary	Symptom scores for nasal and non nasal symptoms		Eighteen months post first dose in TG002	No
Secondary	Skin prick wheal diameter		Eighteen months post first dose in TG002	No
Secondary	Peak Nasal Inspiratory Flow		Eighteen months post first dose in TG002	No
Secondary	Grass specific IgA		Eighteen months post first dose in TG002	No
Secondary	Grass specific IgE		Eighteen months post first dose in TG002	No
Secondary	Grass specific IgG4		Eighteen months post first dose in TG002	No
Secondary	Adverse Events		Eighteen months post first dose in TG002	Yes