Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Recruiting
Phase 2
Phase 3
Interventional Study
Allergic Rhinitis Due to Grass Pollen
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 360 (estimated)
- Sponsor
- Lars Olaf Cardell · Other
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About This Trial
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 …
Trial Locations
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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 …
Contacts