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

Allergic Rhinitis Due to Grass Pollen Clinical Trial

— ILIT vs SLIT  

Official title:

Sublingual Immunotherapy Compared to Intralymphatic Immunotherapy With Concomitant Vitamin D, a Randomised Placebo Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061848
• Other study ID #: Dnr KS: K2021-5840
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2023
• Est. completion date: December 28, 2031

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: Agneta Karlsson, Study nurse
• Phone: +46 72 580 29 63
• Email: agneta.j.karlsson[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 28, 2031
• Est. primary completion date: December 28, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• chronic rhinosinusitis
• Previous immunotherapy
• BMI > 35
• house dust mite allergy with symptoms or allergy towards furry animals with exposition
• 25(OH)Vitamin D levels < 25 or > 75 nmol/L
• 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
• medication with antiepileptic drugs, glykosides, orlistat, statines, thiazide diuretics
• Mb Paget, osteoporosis or sarcidosis
• Hyperparathyroidism or other disease conferring risk of hypercalcemia
• malabsorption or bowel disease with diarrea
• tendency for formation of kidney stones
• hereditary pseudohypoparathyroidism with decreased phosphorous secretion
• use of Vitamin D supplementation or excessive use of sun tanning booths
• drug abuse
• intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1
• Mental incapacity to follow study protocol
• withdrawn consent
• other significant disease
• allergy towards study medication

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Grass Pollen
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	Skåne University Hospital, ENT department	Lund
Sweden	Örebro University Hospital	Örebro
Sweden	Karolinska University Hospital, ENT-department	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Lars Olaf Cardell

Country where clinical trial is conducted

Sweden, 

Outcome

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