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NCT Number: NCT06061848

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

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.

Recruiting

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Key information

Conditions

Allergic Rhinitis Due to Grass Pollen

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Skåne University Hospital, ENT department, Lund, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • withdrawn consent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)

Treatment and study plan

SLIT Grazax ALK Nordic 75 000 SQ-T

Drug

Daily sublingual grass allergen tablets

ILIT + Vitamin D

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

Other names: Alutard SQ timothy and Vicotrat D3

ILIT + placebo

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

Other names: Alutard SQ timothy and Sodium chloride

Primary outcomes

  1. CSMS

    Time frame: 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 outcomes

  1. CSMS peak pollen season

    Time frame: 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

  2. RQLQ

    Time frame: 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)

  3. VAS (0-10)

    Time frame: 4-6 months before treatment and 6-9 months after treatment

    Recalled symptoms severity at visual analogue scale

  4. Serolology with immunoglobulins

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Agneta Karlsson, Study nurse

CONTACT

[email protected]

+46 72 580 29 63

Laila Hellkvist, MD, PhD

CONTACT

[email protected]

+46 72 469 46 07

Sponsors and collaborators

Lead sponsor

Lars Olaf Cardell

Other

Registry information

Acronym: ILIT vs SLIT

Important dates

Study start
2023
Primary completion
2030
Study completion
2031
First posted
Sep 29, 2023
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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