Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Com… (NCT06061848) | Clinical Trial Compass
RecruitingPhase 2/3
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Sweden360 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* withdrawn consent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 hy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CSMS
Timeframe: 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.