Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy (NCT03776643) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy
France24 participantsStarted 2019-02-01
Plain-language summary
Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2 would control allergic responses.
This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch allergen exposure.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
* male or female aged between18-55 years
* Positive clinical history of seasonal allergic rhinitis to birch pollen for at least 2 consecutive pollinic seasons before inclusion and requiring medication intake with or without GINA 1 associated asthma, with documentation of sensitivity within 12 months before enrollment by : \*Positive skin prick test (SPT) and validated in vitro tests for specific Immunoglobulin E (IgE); \*Positive Skin prick test (SPT): wheal for birch pollen ≥ 5 mm in diameter for histamine wheal ≥ 3 mm (positive control) and NaCl reaction \< 2 mm (negative control) \*Positive specific IgE to birch pollen \>0.75 kUI/L;
* Negative beta-HcG pregnancy test at screening visit for women of childbearing age;
* Normal electrocardiogram without clinically significant abnormalities;
* Ability to stay in the EEC for up to 4 hours, without any conditions or factors which could make this not possible
* Positive nasal response (TNSS≥5) at baseline exposure
* Free, informed and written consent signed by the patient and the investigator, before any specific examination required by the study;
* Affiliation to a social security scheme (beneficiary or assignee)
* Negative SARS-CoV-2 test less than 72 hours prior to screening visit
Exclusion Criteria:
* Asthma: GINA 2 to 5
* Eosinophilia \> 0.6x109/mL;
* Any history of anaphylactic reactions;
* Specific immunotherapy treatment at the moment, including Omalizumab;
* Specific immunotherapy for birch-pollens …
What they're measuring
1
Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)