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Clinical Trials in Sweden / NCT06061848
Recruiting Phase 2/3

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

NCT06061848 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lars Olaf Cardell
Phase
Phase 2/3
Started
2023-02-01
Last updated
2024-10-21

Condition(s) studied

Allergic Rhinitis Due to Grass Pollen

Investigational drug(s) / intervention(s)

SLIT Grazax ALK Nordic 75 000 SQ-TILIT + Vitamin DAll ILIT trials (2) →All Vitamin D trials (10) →ILIT + placebo

SLIT Grazax ALK Nordic 75 000 SQ-T: Daily sublingual grass allergen tablets

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8. * informed consent Exclusion Criteria: * chronic rhinosinusitis with or without nose polyps * Previous immunotherapy (SLIT or SCIT) * BMI \> 35 * house dust mite allergy with symptoms * allergy towards furry animals if exposition cannot be avoided * 25(OH)Vitamin D levels \< 25 or \> 75 nmol/L * use of Vitamin D supplementation or excessive use of sun tanning booths * mental incapacity to follow study protocol * other significant disease * allergy towards study medication * uncontrolled asthma * severe atopic dermatitis * pregnancy or nursing * autoimmune disease * hyper IgE-syndrome * cardiovascular disease * lung disease * liver or kidney disease * hematologic disorder * metabolic disease * chronic infectious disese * medications interacting with the immune system * cancer * previous cytostatic therapy * medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment * drug or alcohol abuse * intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 * withdrawn consent Exclusion Criteria only for ILIT group (due to vitamin D treatment) * medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics) * tendency for formation of kidney stones * hyperparathyroidism or other disease conferring risk of hypercalcemia * hereditary pseudohypoparathyroidism with decreased phosphorous secretion * malabsorption or bowel disease with diarrhea * Mb Paget, osteoporosis or sarcoidosis * skin disease at the groin (where the treatment will be injected)

Primary outcome measure(s)

  • CSMS — 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.
    Daily Combined Symptoms and Medication Scores (0-3)

Trial sites (3)

FacilityCityRegionStatus
Skåne University Hospital, ENT department Lund Sweden Not Yet Recruiting
Örebro University Hospital Örebro Sweden Not Yet Recruiting
Karolinska University Hospital, ENT-department Stockholm Sweden Recruiting

More Lars Olaf Cardell trials in Sweden

Immune Response in Cervical Lymph Nodes of Patients With Head and Neck Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06061848 on ClinicalTrials.gov ↗ ← All trials in Sweden