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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8.

• informed consent

Locations
Other Locations
Sweden
Skåne University Hospital, ENT department
NOT_YET_RECRUITING
Lund
Örebro University Hospital
NOT_YET_RECRUITING
Örebro
Karolinska University Hospital, ENT-department
RECRUITING
Stockholm
Contact Information
Primary
Agneta Karlsson, Study nurse
agneta.j.karlsson@regionstockholm.se
+46 72 580 29 63
Backup
Laila Hellkvist, MD, PhD
laila.hellkvist@regionstockholm.se
+46 72 469 46 07
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2031-12-28
Participants
Target number of participants: 360
Treatments
Active_comparator: SLIT
Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years
Active_comparator: ILIT + Vitamin D
Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Active_comparator: ILIT + placebo
Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Related Therapeutic Areas
Sponsors
Leads: Lars Olaf Cardell

This content was sourced from clinicaltrials.gov