NCT02679105

Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U -a Human Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic

Interventions

Type	Name	Description
DRUG	ALK Alutard birch or 5-grasses	3 injections with 4-5 weeks interval.
DRUG	ALK diluent	0,3% human albumin

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-10-01
• Completion: 2019-03-01
• First posted: 2016-02-10
• Last updated: 2019-09-04

Locations

3 sites across 1 country: Sweden