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New treatment option for Allergic Rhinitis Due to Grass Pollen
Official title Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
ClinicalTrials.gov ID: NCT06061848
What this study is testing
What is SLIT Grazax ALK Nordic 75 000 SQ-T?
SLIT Grazax ALK Nordic 75 000 SQ-T is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for allergic rhinitis due to grass pollen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8.
- informed consent
You likely can't join if
- 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 \ 75 nmol/L
See the full eligibility criteria
- moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8.
- informed consent
- 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 \ 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)
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Sweden
- Örebro, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Sweden; Örebro, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.