Status:
COMPLETED
Safety of ToleroMune Ragweed to Treat Ragweed Allergy in Ragweed Allergic Subjects With Rhinoconjunctivitis
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
Adiga Life Sciences, Inc.
Conditions:
Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
It is estimated that 36 million Americans suffer from seasonal allergies and that ragweed is the primary cause of autumn allergies, 87% of patients with ragweed allergy suffer rhinoconjunctivitis. Tol...
Detailed Description
This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Ragweed in subjects with a documented ...
Eligibility Criteria
Inclusion
- Male or female, aged 18-65 years
- A reliable, documented history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) on exposure to ragweed for at least 2 years
- Allergy to ragweed, defined by positive skin prick test at the Screening Visit
- LPSR to ragweed allergen 8 hours after intradermal injection of greater than 25mm diameter response
- Positive CPT to ragweed allergen with a score ≥4
- Willing and able to provide written informed consent
- Subjects who are normally active and otherwise judged to be in good health
- The subject must be willing and able to comply with the study requirements
- If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal
Exclusion
- Subjects with an FEV1 \<80% of normal
- Subjects who suffer from other seasonal allergies, and cannot complete the clinical study outside the pollen season or are symptomatic for significant perennial rhinitis
- A history of anaphylaxis to ragweed allergen; subjects who have a history of severe drug allergy, angioedema or anaphylactic reactions to food
- Subjects with a history of asthma
- Subjects who have auto-immune or rheumatoid diseases
- Clinical history of immunodeficiency, including immunosuppressant therapy
- Subjects in whom tyrosine metabolism is disturbed
- Current diagnosis of chickenpox or measles or exposure in the last 3 weeks
- Active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex
- Have symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit
- Allergen immunotherapy during the last 5 years or ragweed immunotherapy ever.
- Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody
- Use of the therapies listed in Section 5.9.2 at any time during the study will make the subject ineligible for the study
- Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension)
- Subjects being treated with beta-blockers
- The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit
- Female subjects who are pregnant, lactating or planning a pregnancy during the study
- Have any clinically relevant abnormalities detected on physical examination
- 12-lead ECG or vital signs (blood pressure, pulse rate, respiratory rate and oral temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator
- Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator
- Significant history of alcohol or drug abuse
- History of immunopathological disease
- Positive test for hepatitis B, hepatitis C or HIV at screening
- Have previously been randomised into this study
- Planned travel outside the study area for a substantial portion of the study period
- Have received treatment with an investigational drug within 6 months prior to study screening or have participated in a study with a new formulation of a marketed drug one month prior to study screening
- Have any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00878774
Start Date
April 1 2009
End Date
November 1 2009
Last Update
November 10 2010
Active Locations (1)
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1
Centre de Recherche Appliqué en Allergie de Québec
Québec, Quebec, Canada, G1V 4M6