Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
This trial is active, not recruiting.
|Sponsor||Adiga Life Sciences, Inc.|
|Start date||October 2015|
|End date||October 2017|
|Trial size||199 participants|
|Trial identifier||NCT02601690, RES-010|
This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a non-interventional study in which no investigational product will be administered to any subject.
|Observational model||ecologic or community|
Participants allergic to one or more of cat, rye grass, ragweed or house dust mite.
Evaluation of T cell responses to SPIREs
time frame: 2 years
Characterization of the distribution of allergen sensitivity across a broad range of common allergens
time frame: 2 years
Male or female participants from 18 years up to 65 years old.
- Male or female, aged 18-65 years.
- Willing and able to provide written informed consent.
- One year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, Rye grass, or HDM.
- Positive skin prick test to each allergen for which a subject has a qualifying clinical history.
- Clinically relevant history of alcohol or drug abuse.
- Use of any oral or parenteral (except low dose inhaled) corticosteroids within 2 months prior to the visit or any other immunosuppressive therapy within 3 months prior to the visit.
- Vaccination/ inoculation within the 6 weeks prior to the first visit.
- A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis).
- Subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study.
- Recent blood donation of an amount of >100 mL.
- Immunotherapy within the last 5 years to any of the allergens for which a subject would otherwise be eligible on the basis of clinical history and skin prick test result.
|Official title||Observational, Cross-sectional Analysis of T Cell Responses to Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) for Multiple Allergens in Subjects With Allergy in North America|
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