NCT02975479

Intralymphatic Immunotherapy in Increasing Doses, Substudy

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• 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 with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo. \*\*\*IMPORTANT INFORMATION!\*\*\* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.

Detailed description

40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	ALK Diluent
DRUG	ALK Alutard SQ 5-grasses or ALK Alutard Birch	Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.

Timeline

• Start date: 2016-05-01
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2016-11-29
• Last updated: 2022-06-24

Locations

2 sites across 1 country: Sweden