NCT06061848View on ClinicalTrials.gov

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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

December 28, 2030

Study Completion Date

December 28, 2031

Conditions
Allergic Rhinitis Due to Grass Pollen
Interventions
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

Trial Locations (3)

Unknown

NOT_YET_RECRUITING

Skåne University Hospital, ENT department, Lund

NOT_YET_RECRUITING

Örebro University Hospital, Örebro

RECRUITING

Karolinska University Hospital, ENT-department, Stockholm

All Listed Sponsors
lead

Lars Olaf Cardell

OTHER