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

NCT ID: NCT06061848

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2031-12-28

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.

Conditions

Allergic Rhinitis Due to Grass Pollen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SLIT

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

Group Type: ACTIVE_COMPARATOR

SLIT Grazax ALK Nordic 75 000 SQ-T

Intervention Type: DRUG

Daily sublingual grass allergen tablets

ILIT + Vitamin D

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

Group Type: ACTIVE_COMPARATOR

ILIT + Vitamin D

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

ILIT + placebo

Intervention Type: DRUG

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

Interventions

SLIT Grazax ALK Nordic 75 000 SQ-T

Daily sublingual grass allergen tablets

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Alutard SQ timothy and Vicotrat D3; Alutard SQ timothy and Sodium chloride

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lars Olaf Cardell

OTHER

Sponsor Role: lead

Responsible Party

Lars Olaf Cardell

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars O Cardell, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Skåne University Hospital, ENT department

Lund, , Sweden

Site Status: NOT_YET_RECRUITING

Örebro University Hospital

Örebro, , Sweden

Site Status: NOT_YET_RECRUITING

Karolinska University Hospital, ENT-department

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Agneta Karlsson, Study nurse

Role: CONTACT

agneta.j.karlsson@regionstockholm.se

+46 72 580 29 63

Laila Hellkvist, MD, PhD

Role: CONTACT

laila.hellkvist@regionstockholm.se

+46 72 469 46 07

Facility Contacts

Franziska Nordström, MD

Role: primary

franziska.nordstrom@skane.se

Amanj Saber, MD

Role: primary

amanj.saber@regionorebrolan.se

Eirini Paziou, MD

Role: primary

eirini.paziou@regionstockholm.se

+46 8 123 723 96

Laila Hellkvist, MD, PhD

Role: backup

laila.hellkvist@regionstockholm.se

+46 72 469 46 07

Other Identifiers

Dnr KS: K2021-5840

Identifier Type: -

Identifier Source: org_study_id