NCT01447784

Brief Summary

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients. ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of HDM allergy This study will look at the efficacy, safety and tolerability of three doses of ToleroMune HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental Exposure Chamber (EEC)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

1.7 years

First QC Date

October 5, 2011

Last Update Submit

July 16, 2013

Conditions

Rhinoconjunctivitis

Keywords

HDM allergyRhinoconunctivitisEnvironmental Exposure ChamberImmunotherapyToleroMune HDM

Outcome Measures

Primary Outcomes (1)

  • Total Rhinoconjunctivitis Symptom Score

    Up to 47 weeks

Secondary Outcomes (7)

  • Symptom scores for nasal and non-nasal symptoms

    Up to 47 weeks

  • Total Rhinoconjunctivitis Symptom Score

    Up to 19 weeks

  • Total Rhinoconjunctivitis Symptom Score

    Up to 36 weeks

  • HDM specific IgA

    Up to 53 weeks

  • HDM specific IgE

    Up to 53 weeks

  • +2 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Biological: Placebo

ToleroMune HDM Dose 1

EXPERIMENTAL
Biological: ToleroMune HDM

ToleroMune HDM Dose 2

EXPERIMENTAL
Biological: ToleroMune HDM

ToleroMune HDM Dose 3

EXPERIMENTAL
Biological: ToleroMune HDM

Interventions

ToleroMune HDMBIOLOGICAL

Intradermal injection 1 x 11 administrations 4 weeks apart

ToleroMune HDM Dose 1ToleroMune HDM Dose 2ToleroMune HDM Dose 3
PlaceboBIOLOGICAL

Intradermal injection 1 x 11 administrations 4 weeks apart

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18-65 years.
  • Minimum 1-year documented history of rhinoconjunctivitis on exposure to HDM.
  • Positive skin prick test to Der p allergen.
  • Minimum qualifying rhinoconjunctivitis symptom scores

You may not qualify if:

  • History of asthma (asthma in childhood .
  • A history of anaphylaxis to HDM allergen.
  • Subjects with an FEV1 \<80% of predicted.
  • Subjects who cannot tolerate baseline challenge in the EEC.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

Study Officials

  • Deepen Patel, MD, CCFP

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 6, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

CA(1)