ToleroMune Grass Exposure Unit Study

NCT01385800 | Completed Phase 2

• 1 other identifier: TG002
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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. This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).

Conditions

Grass Allergy; Rhinoconjunctivitis

Keywords

Grass allergy; Rhinoconjunctivitis; Environmental Exposure Unit; Immunotherapy; ToleroMune Grass

Outcome Measures

Primary Outcomes (1)

• Total Rhinoconjunctivitis Symptom Score

  Upto 25 weeks

Secondary Outcomes (7)

• Symptom scores for nasal and non nasal symptoms

  Upto 25 weeks

• Skin prick testing

  Upto 25 weeks

• Peak Nasal Inspiratory Flow

  Up to 25 weeks

• Grass specific IgA

  Upto 26 weeks

• Grass specific IgE

  Upto 26 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Intradermal injection, 1 x 8 administrations 2 weeks apart

Biological: Placebo

ToleroMune Grass Dose 1

EXPERIMENTAL

Intradermal injection 1 x 8 administrations 2 weeks apart

Biological: ToleroMune Grass

ToleroMune Grass Dose 2

EXPERIMENTAL

Intradermal injection 1 x 8 administrations 2 weeks apart

Biological: ToleroMune Grass

ToleroMune Grass Dose 3

EXPERIMENTAL

Intradermal injection 1 x 8 administrations 2 weeks apart

Biological: ToleroMune Grass

Interventions

ToleroMune Grass BIOLOGICAL

Intradermal injection 1 x 8 administrations 2 weeks apart

ToleroMune Grass Dose 1; ToleroMune Grass Dose 2; ToleroMune Grass Dose 3

Placebo BIOLOGICAL

Intradermal injection 1 x 8 administrations 2 weeks apart

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18-65 years.
• Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass.
• Positive skin prick test to grass allergen.
• Minimum qualifying rhinoconjunctivitis symptom scores

You may not qualify if:

• History of asthma.
• A history of anaphylaxis to grassallergen.
• Subjects with an FEV1 \<80% of predicted.
• Subjects who cannot tolerate baseline challenge in the EEU.
• Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
• A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
• A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator
• Pharm-Olam International: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Study Officials

• Anne K Ellis, MD MSC FRCPC

  Queen's University, Kingston, Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

CA (1)