A Phase 2/3 interventional study of SLIT Grazax ALK Nordic 75 000 SQ-T and ILIT + Vitamin D in Allergic Rhinitis Due to Grass Pollen, sponsored by Lars Olaf Cardell. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Lars Olaf Cardell · Phase 2/3, Interventional, and Treatment
Among 22 studies in Rhinitis, Allergic with a site in Sweden — 2 open to participants now, 2 under way, 1 of them phase 3. Rhinitis, Allergic · Sweden.
Among the 22 studies in Rhinitis, Allergic with a site in Sweden, this one is the 4th largest by planned enrollment, is the only one that started in 2023, is one of 6 in phase 2/3, and was the 21st registered.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
Browse Rhinitis, Allergic studies →2 of the 22 studies in Rhinitis, Allergic with a site in Sweden are open now. Recruiting first, the newest first:
Karolinska Institutet · Sites in Sweden
Ages 18–50
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 54 Rhinitis, Allergic studies recruiting now, 11 (20%) set no upper age limit and 38 (70%) stop at 75 or younger; 22 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 13 · Phase 3 8 · Phase 4 3
First in 2001; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 360 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Median enrollment 69 across the 22 interventional studies. Of the 20 that completed or were terminated, 2 (10%) have results posted.
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11 of 22 have an industry lead sponsor. The 10 most frequent:
Lars Olaf Cardell is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Lars Olaf Cardell has 3 studies filed under Rhinitis, Allergic — fewer than ten, so there is no comparison to draw.
1 of the studies in Rhinitis, Allergic with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07651891Karolinska InstitutetEvaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice | 2027-10-01 |
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Among the 22 studies in Rhinitis, Allergic with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusion Criteria only for ILIT group (due to vitamin D treatment)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years
Drug: SLIT Grazax ALK Nordic 75 000 SQ-T
Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Drug: ILIT + Vitamin D
Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.
Drug: ILIT + placebo
Daily sublingual grass allergen tablets
Drug page: Vitamin D
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
Also known as: Alutard SQ timothy and Vicotrat D3
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
Also known as: Alutard SQ timothy and Sodium chloride
CSMS
Daily Combined Symptoms and Medication Scores (0-3)
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.
CSMS peak pollen season
Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count
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.
RQLQ
Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28)
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.
VAS (0-10)
Recalled symptoms severity at visual analogue scale
Time frame: 4-6 months before treatment and 6-9 months after treatment
Serolology with immunoglobulins
Total and grass specific levels of IgE, IgG, IgG4, IgA in serum
Time frame: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Dec 2030, 94 months after the start.
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Studies of the drug tested here: Vitamin D
Lars Olaf Cardell