drugset / Trial / NCT06061848

Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

NCT06061848

Phase 2/3 Recruiting 360 enrolled Lars Olaf Cardell
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.

Timeline

Start
2023-02-01
Primary completion
2030-12-28
Completion
2031-12-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alutard SQ timothy Unknown 0.1 ml Other
Comparator Grazax Other / unclassified 75000 unknown Other
Comparator kolecalciferol Unknown 100000 iu Intramuscular