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

Phase 2

Recruiting

• Conditions: Allergic Rhinitis Due to Grass Pollen
• Interventions: Drug: ILIT + Vitamin D; Drug: ILIT + placebo; Drug: SLIT Grazax ALK Nordic 75 000 SQ-T

• Registration Number: NCT06061848
• Lead Sponsor: Lars Olaf Cardell

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2030-12-28
• Study Completion: 2031-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILIT + Vitamin D	ILIT + Vitamin D	Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
ILIT + placebo	ILIT + placebo	Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
SLIT	SLIT Grazax ALK Nordic 75 000 SQ-T	Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
RQLQ	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.	Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28)
CSMS peak pollen season	15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.	Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count
Serolology with immunoglobulins	1 year before treatment, 4-6 weeks after treatment, 1 year after treatment	Total and grass specific levels of IgE, IgG, IgG4, IgA in serum
VAS (0-10)	4-6 months before treatment and 6-9 months after treatment	Recalled symptoms severity at visual analogue scale

Trial Locations

Locations (3)

Örebro University Hospital; 🇸🇪 Örebro, Sweden

Karolinska University Hospital, ENT-department; 🇸🇪 Stockholm, Sweden

Skåne University Hospital, ENT department; 🇸🇪 Lund, Sweden