Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Terminated
- Conditions
- Allergy
- Registration Number
- NCT02601690
- Lead Sponsor
- Adiga Life Sciences, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 199
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of T cell responses to SPIREs 2 years
- Secondary Outcome Measures
Name Time Method Characterization of the distribution of allergen sensitivity across a broad range of common allergens 2 years
Trial Locations
- Locations (2)
Empire Clinical Research
🇺🇸Upland, California, United States
O&O Alpan
🇺🇸Fairfax, Virginia, United States
Empire Clinical Research🇺🇸Upland, California, United States