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

Lars Olaf Cardell

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Allergic Rhinitis Due to Grass Pollen

Treatments: Drug: SLIT Grazax ALK Nordic 75 000 SQ-T; Drug: ILIT + Vitamin D; Drug: ILIT + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06061848

Dnr KS: K2021-5840

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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• withdrawn consent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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups

SLIT

Active Comparator group

Description:

Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years

Treatment:

Drug: SLIT Grazax ALK Nordic 75 000 SQ-T

ILIT + Vitamin D

Active Comparator group

Description:

Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.

Treatment:

Drug: ILIT + Vitamin D

ILIT + placebo

Active Comparator group

Description:

Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.

Treatment:

Drug: ILIT + placebo