Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-04 @ 2:52 PM
Study NCT ID:
NCT02679105
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2016-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U -a Human Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-09
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:
None
Brief Summary:
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
Detailed Description:
38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: