Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study (ILIT vs SLIT)
Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study (ILIT vs SLIT)
ClinicalTrials.gov ID: NCT06061848
Sponsor: Lars Olaf Cardell
Information provided by: Lars Olaf Cardell, Karolinska Institutet (Responsible Party)
Last Update Posted: 2023-09-29
Brief 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.
Official Title:
Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study
Intervention / Treatment:
- Drug: SLIT Grazax ALK Nordic 75 000 SQ-T
- Drug: ILIT + Vitamin D
- Drug: ILIT + placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-02-01 |
| Primary Completion (Estimated) | 2030-12-28 |
| Study Completion (Estimated) | 2031-12-28 |
| Enrollment (Estimated) | 360 |
| Study Type | Interventional |
| Phase | Phase 2 Phase 3 |
| Other Study ID Numbers |
Dnr KS: K2021-5840 |