Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03776643
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2018-11-20
Brief Title:
Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rhinil-2
Brief Summary:
Several studies have reported a deficit andor 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
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
Detailed Description:
Primary objective To evaluate the efficacy of ILT-101 ld-IL-2 compared to placebo on nasal response on day 40
Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms on inflammatory mediators allergic specific immune responses and safety
Experimental design This is a monocentric randomized placebo controlled double-blind trial in parallel-groups evaluating a treatment by ILT-101placebo 1 MIU daily for 5 days and 1 MIU every week until day 36
Population involved Male or female aged between 18 and 55 years with allergic rhinitis to birch pollen
Number of subjects 24
Duration of patient participation 3 months treatment period 36 days months follow-up period 34 days
Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms on inflammatory mediators allergic specific immune responses and safety
Experimental design This is a monocentric randomized placebo controlled double-blind trial in parallel-groups evaluating a treatment by ILT-101placebo 1 MIU daily for 5 days and 1 MIU every week until day 36
Population involved Male or female aged between 18 and 55 years with allergic rhinitis to birch pollen
Number of subjects 24
Duration of patient participation 3 months treatment period 36 days months follow-up period 34 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None