drugset / Trial / NCT06061848
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alutard SQ timothy | Unknown | 0.1 ml | Other |
| Comparator | Grazax | Other / unclassified | 75000 unknown | Other |
| Comparator | kolecalciferol | Unknown | 100000 iu | Intramuscular |