NCT06061848|RecruitingPhase 2/3DMC
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
ILIT vs SLIT
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Sponsor study identifier
interventional
360
1 country
3
Study Start
February 1, 2023
Actual (reported)Primary Completion
December 28, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 28, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2023
Actual (reported)September 11, 2023
Actual (reported)September 29, 2023
Actual (reported)December 28, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 28, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
CSMS
Daily Combined Symptoms and Medication Scores (0-3)
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.
CSMS peak pollen season
15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.
RQLQ
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.
VAS (0-10)
4-6 months before treatment and 6-9 months after treatment
Serolology with immunoglobulins
1 year before treatment, 4-6 weeks after treatment, 1 year after treatment
Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years
Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Daily sublingual grass allergen tablets
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
Skåne University Hospital, ENT department
Lund, Sweden
Örebro University Hospital
Örebro, Sweden
Lars O Cardell, Professor
Karolinska Institutet
First Submitted
September 11, 2023
First Posted
September 29, 2023
Study Start
February 1, 2023
Actual (reported)Primary Completion
December 28, 2030
EstimatedProspective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)
Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis
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
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Karolinska University Hospital, ENT-department
Stockholm, Sweden
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 28, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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