Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America

Adiga Life Sciences

Status: Terminated

Conditions: Allergy

Treatments: Other: Blood Sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT02601690

RES-010

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, aged 18-65 years.
2. Willing and able to provide written informed consent.
3. One year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, Rye grass, or HDM.
4. Positive skin prick test to each allergen for which a subject has a qualifying clinical history.

Exclusion criteria

1. Clinically relevant history of alcohol or drug abuse.
2. 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.
3. Vaccination/ inoculation within the 6 weeks prior to the first visit.
4. 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).
5. Subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study.
6. Recent blood donation of an amount of >100 mL.
7. 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.

Trial design

199 participants in 1 patient group

Blood Sampling

Description:

Participants allergic to one or more of cat, rye grass, ragweed or house dust mite.

Treatment:

Other: Blood Sampling