Safety of ToleroMune House Dust Mite (HDM) to Treat House Dust Mite Allergy in HDM Allergic Subjects With Rhinoconjunctivitis

NCT01008332 | Completed Phase 2

• 1 other identifier: TH001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of allergic sensitisation to House Dust Mite (HDM) varies from region to region and depends on the regional prevalence of HDM. In the third National Health and Nutrition Examination Surveys, 54.3% of the US population had positive test responses to one or more allergens, with the prevalence for HDM being 27.5%. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of Houst Dust Mite allergy. The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune HDM in subjects in subjects with a documented history of allergic rhinoconjunctivitis on exposure to house dust mite. The efficacy of ToleroMune HDM will also be explored in these subjects using the Late Phase Skin Response, Early Phase Skin Response and Conjunctival Provocation Test.

Conditions

Allergy

Keywords

House Dust Mite Allergy; Immunotherapy; Rhinoconjunctivitis; Toleromune HDM

Outcome Measures

Primary Outcomes (1)

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

  18-22 weeks

Secondary Outcomes (4)

• Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo

  18-22 weeks

• Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole HDM allergen at PTC after ToleroMune HDM injection compared to placebo

  18-22 weeks

• Mean change from baseline in CPT score at PTC after ToleroMune HDM injection compared to placebo

  18-22 weeks

• Mean change from baseline in concentration of HDM specific IgE at PTC after ToleroMune HDM injection compared to placebo

  18-22 weeks

Study Arms (5)

Cohort 1

EXPERIMENTAL

ToleroMune HDM, subjects to receive either active or placebo comparator

Biological: Toleromune HDM; Biological: Placebo

Cohort 2

EXPERIMENTAL

ToleroMune HDM, subjects to receive either active or placebo comparator

Biological: Toleromune HDM; Biological: Placebo

Cohort 3

EXPERIMENTAL

ToleroMune HDM, subjects to receive either active or placebo comparator

Biological: Toleromune HDM; Biological: Placebo

Cohort 4

EXPERIMENTAL

ToleroMune HDM, subjects to receive either active or placebo comparator

Biological: Toleromune HDM; Biological: Placebo

Cohort 5

EXPERIMENTAL

Toleromune HDM, subjects to receive either active or placebo comparator

Biological: Toleromune HDM; Biological: Placebo

Interventions

Toleromune HDM BIOLOGICAL

ToleroMune HDM dose 1x4 administrations 4 weeks apart

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

Placebo BIOLOGICAL

Placebo comparator, 1x4 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
• Miniumum 1 year history of rhinoconjunctivitis on exposure to HDM
• Positive skin prick test to whole Der p allergen
• LPSR to whole Der p allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
• Positive CPT to whole Der p 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 Der f or Der p specific IgE \>100 kU/L
• Subjects with an acute phase skin response to whole Der p or whole Der f 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, tranquillizers 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, Canada

Location

MeSH Terms

Conditions

Hypersensitivity; Dust Mite Allergy

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Study Officials

• Jacques Hebert, MD

  Centre de Recherche Appliqué en Allergie de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 5, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 10, 2010

Record last verified: 2010-11

Locations

CA (1)