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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)