Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Stopped early
Conditions studied: Allergy
In brief
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.
Key facts
- Study ID
- NCT02601690
- Run by
- Adiga Life Sciences, Inc.
- People needed
- 199
- Starts
- 2015-10-01
- Expected to finish
- 2017-06-25
- Last updated by the study team
- 2019-04-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Empire Clinical Research — Upland, California, United States
- O&O Alpan — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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