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

NCT01166061 | Completed Phase 2

• 1 other identifier: TG001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized 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 the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.

Conditions

Allergy

Keywords

Grass Allergy; Immunotherapy; Rhinoconjunctivitis; ToleroMune Grass

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of multiple intradermal injections of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis

  Upto 22 weeks

Secondary Outcomes (12)

• Area of Late Phase Skin Response

  Baseline and 14 weeks

• Area of Early Phase Skin Response

  Baseline and 14 weeks

• Change in CPT score

  Baseline and 4 weeks

• Grass specific IgG4

  Baseline and 14 weeks

• Change in CPT score

  Baseline and 14 weeks

Study Arms (5)

Cohort 1

EXPERIMENTAL

Subjects to receive either active or placebo

Biological: Placebo; Biological: ToleroMune Grass

Cohort 2

EXPERIMENTAL

Subjects to receive either active or placebo comparator

Biological: Placebo; Biological: ToleroMune Grass

Cohort 3

EXPERIMENTAL

Subjects to receive either active or placebo comparator

Biological: Placebo; Biological: ToleroMune Grass

Cohort 4

EXPERIMENTAL

Subjects to receive either active or placebo comparator

Biological: Placebo; Biological: ToleroMune Grass

Cohort 5

EXPERIMENTAL

Subjects to receive either active or placebo comparator

Biological: Placebo; Biological: ToleroMune Grass

Interventions

Placebo BIOLOGICAL

Solution resembling active solution but without peptides

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

ToleroMune Grass BIOLOGICAL

1 x4 administrations 4 weeks apart

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

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 history of rhinoconjunctivitis on exposure to grass
• Positive skin prick test to whole grass allergen
• LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
• Positive CPT to whole grass allergen with a score ≥4

You may not qualify if:

• Subjects with a history of asthma
• Subjects with an FEV1 \<80% of predicted
• Subjects with a rye grass specific IgE \>100 kU/L
• Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter \> 50 mm
• Subjects who score \>1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
• Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs
• History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (1)

Centre de Recherche Appliqué en Allergie de Québec

Québec, Quebec, G1V 4M6, Canada

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jacques Hebert, MD

  Centre de recherche appliquée en allergie de Quebec

  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

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 20, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 20, 2011

Record last verified: 2011-05

Locations

CA (1)