Allergic Rhinitis Due to Grass PollenPhase 2/3ILIT vs SLITNCT06061848
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
A Phase 2/3 study testing SLIT Grazax ALK Nordic 75 000 SQ-T and ILIT + Vitamin D in people with Allergic Rhinitis Due to Grass Pollen, run by Lars Olaf Cardell at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollen
- What is being tested?
- SLIT Grazax ALK Nordic 75 000 SQ-T and ILIT + Vitamin D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Feb 2023to 28 Dec 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.
- informed consent
Who cannot join
- 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
Show all 36Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Not yet recruiting
Skåne University Hospital, ENT department
Lund
Franziska Nordström, MD, franziska.nordstrom@skane.se
- Not yet recruiting
Örebro University Hospital
Örebro
Amanj Saber, MD, amanj.saber@regionorebrolan.se
- Recruiting
Karolinska University Hospital, ENT-department
Stockholm
Eirini Paziou, MD, +46 8 123 723 96, eirini.paziou@regionstockholm.se
Laila Hellkvist, MD, PhD, +46 72 469 46 07, laila.hellkvist@regionstockholm.se
About this study
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.
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Being tested
- SLIT Grazax ALK Nordic 75 000 SQ-T, ILIT + Vitamin D, ILIT + placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLIT Grazax ALK Nordic 75 000 SQ-TDrug
Daily sublingual grass allergen tablets
ILIT + Vitamin DDrug
Also called Alutard SQ timothy and Vicotrat D3
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
ILIT + placeboDrug
Also called Alutard SQ timothy and Sodium chloride
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
| Study group | Role | What they receive |
|---|---|---|
| SLIT | Active comparator | Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years Receives: Drug: SLIT Grazax ALK Nordic 75 000 SQ-T |
| ILIT + Vitamin D | Active comparator | Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U. Receives: Drug: ILIT + Vitamin D |
| ILIT + placebo | Active comparator | Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U. Receives: Drug: ILIT + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSMS
Daily Combined Symptoms and Medication Scores (0-3)
Measured: 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.
Secondary outcomes (4)
CSMS peak pollen season
Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count
Measured: 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)
Measured: 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
Measured: 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
Measured: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Feb 2023
- Primary completion28 Dec 2030 (estimated)
- Study completion28 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Grass PollenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Olaf Cardell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Olaf Cardell, Karolinska Institutet
- Investigators
- Lars O Cardell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061848
- Sponsor's protocol ID
- Dnr KS: K2021-5840
- Acronym
- ILIT vs SLIT
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
- ClinicalTrials.gov ID
- NCT06061848
- Acronym / sponsor ID
- ILIT vs SLIT / Dnr KS: K2021-5840
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Lars Olaf CardellUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Dec 2030 (estimated)
- Study completion
- 28 Dec 2031 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLIT | Active comparator | Drug: SLIT Grazax ALK Nordic 75 000 SQ-TSublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years |
| ILIT + Vitamin D | Active comparator | Drug: ILIT + Vitamin DIntramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U. |
| ILIT + placebo | Active comparator | Drug: ILIT + placeboIntramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.
- informed consent
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLIT Grazax ALK Nordic 75 000 SQ-TDaily sublingual grass allergen tablets | Drug | SLIT |
| ILIT + Vitamin DAlso: Alutard SQ timothy and Vicotrat D31 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 | Drug | ILIT + Vitamin D |
| ILIT + placeboAlso: Alutard SQ timothy and Sodium chloride1 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 | Drug | ILIT + placebo |
Primary outcome
CSMS
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.
Daily Combined Symptoms and Medication Scores (0-3)
4 secondary outcomes
CSMS peak pollen season
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
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)
Time frame: 4-6 months before treatment and 6-9 months after treatment
Serolology with immunoglobulins
Time frame: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis Due to Grass Pollen
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
Active, not recruitingObservational study
Tyrosine Allergoid Paediatric and Adult Study
Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars O Cardell, Professor principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SLIT Grazax ALK Nordic 75 000 SQ-T and ILIT + Vitamin D in people with Allergic Rhinitis Due to Grass Pollen, run by Lars Olaf Cardell at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agneta Karlsson, Study nurse (+46 72 580 29 63, agneta.j.karlsson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSMS (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.