NCT06061848

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Lars Olaf Cardell · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis Due to Grass Pollen

Interventions

Type	Name	Description
DRUG	SLIT Grazax ALK Nordic 75 000 SQ-T	Daily sublingual grass allergen tablets
DRUG	ILIT + Vitamin D	1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU/mL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
DRUG	ILIT + placebo	1 ml of Sodium chloride solution 9 mg/mL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections

Timeline

• Start date: 2023-02-01
• Primary completion: 2030-12-28
• Completion: 2031-12-28
• First posted: 2023-09-29
• Last updated: 2024-10-21

Locations

3 sites across 1 country: Sweden