Clinical trial NCT01198613: ToleroMune Ragweed Exposure Chamber Study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate Two Doses of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ragweed Allergy
Keywords: Ragweed allergy
Rhinoconjunctivitis
Exposure chamber
Immunotherapy
ToleroMune Ragweed
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Cetero Research, San Antonio
First posted: 2010-09-10
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.

This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

Detailed description: This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Eligibility criteria: Inclusion criteria

* Male or female, aged 18-65 years.
* Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. \[Subjects may also have controlled asthma
* Positive skin prick test to ragweed allergen.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

* History of asthma.
* A history of anaphylaxis to ragweed allergen.
* Subjects with an FEV1 \<70% 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).

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: Upto 22 weeks
Secondary outcomes:
measure: Symptom scores for ocular and nasal symptoms
timeFrame: Upto 22 weeks
measure: Acoustic Rhinometry
timeFrame: Upto 22 weeks
measure: Skin prick testing
timeFrame: Baseline and final follow up
measure: Ragweed specific IgE
timeFrame: At baseline and at follow up
measure: Ragweed specific IgA
timeFrame: At baseline and follow up
measure: Ragweed specific IgG4
timeFrame: At baseline and at follow up
measure: Adverse Events
timeFrame: Upto 23 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Deepen Patel, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References: