Allergic Rhinitis Due to Grass PollenPhase 3ILITNUNCT05191186
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy
A Phase 3 study testing Grass pollen extract - Alutard Phleum pratense, ALK in people with Allergic Rhinitis Due to Grass Pollen and Allergic Conjunctivitis of Both Eyes, run by Aarhus University Hospital at 2 sites in 2 countries.
Trial summary
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollen, Allergic Conjunctivitis of Both Eyes, Allergic Asthma
- What is being tested?
- Grass pollen extract - Alutard Phleum pratense, ALK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2020to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate-severe grass pollen allergic rhinoconjunctivitis
- positive skin prick test for grass pollen extract
Who cannot join
- significant mugwort allergy
- previous AIT for grass pollen allergy
- uncontrolled non-allergic upper airways disease
- uncontrolled asthma
- planned depot steroid injections during season
- uncontrolled autoimmune diseases
- active malignancies
- uncontrolled other severe condition, including psychiatric diseases
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo
Read the detailed description
A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects.
Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo.
Injections are giving ultrasound-guided with at least 4 weeks intervals.
To increase trial retention, two studies within the trial are conducted: a feasibility study assessing the acceptability and feasibility of a digital intervention and its evaluation design. Outcomes include participant and stakeholder acceptability, reach, mechanisms of change to improve trial retention, utilization, unintended effects, software functionality, recruitment and retention rates, questionnaire suitability, randomization feasibility, power for a future definitive trial, and initial efficacy signals. Additionally, an evaluation study assesses the efficacy of the intervention.
- Conditions
- Allergic Rhinitis Due to Grass Pollen, Allergic Conjunctivitis of Both Eyes, Allergic Asthma
- Being tested
- Grass pollen extract - Alutard Phleum pratense, ALK
- Keywords
- Allergen immunotherapy, Allergic rhinoconjunctivitis, grass pollen allergy, intralymphatic immunotherapy, ILIT.NU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen extract - Alutard Phleum pratense, ALKDrug
Also called immunotherapy
injection in lymph node
| Study group | Role | What they receive |
|---|---|---|
| grass pollen extract treatment | Active comparator | participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract Receives: Drug: Grass pollen extract - Alutard Phleum pratense, ALK |
| Placebo | Placebo comparator | Participants receive 3 injections with saline (NaCl 0.9%) Receives: Drug: Grass pollen extract - Alutard Phleum pratense, ALK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined symptom and medication score, cSMS
daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo.
cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use.
This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication
Measured: 2 years
Secondary outcomes (5)
side-effects
occurence of side-effects as compared to placebo
Measured: 3 months
correlation of CSMS to pollen count
correlate cSMS to daily pollen counts
Measured: 2 years
combined symptom and medication score, cSMS
change in the combined symptom and medication score from baseline
Measured: 2 years
Rhinitis related quality of life, RQLQ
changes on rhinitis related quality of life
Measured: 2 years
Airwave oscillometry system(AOS), asthma
Influence of ILIT on resistance in the lower airways measured by AOS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Feb 2020
- Primary completion1 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis Due to Grass PollenStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group, double blind placebo controlled multi site
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, University Hospital, Linkoeping
- Responsible party
- Principal investigator, Johannes Martin Schmid, Aarhus University Hospital
- Investigators
- Johannes M Schmid, MD PhD, Principal investigator, Aarhus University Hospital/Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191186
- Sponsor's protocol ID
- 2020-001060-28
- Acronym
- ILITNU
- Status last verified
- Aug 2025
- First submitted
- 27 Dec 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will publish data
Publications
Petersen AP, Schmid JM, Hoffmann HJ, Finderup J. Acceptability and feasibility of a need-supportive intervention to increase trial retention: a randomised feasibility study within a randomised controlled allergy trial in Denmark. BMJ Open. 2025 Sep 14;15(9):e101046. doi: 10.1136/bmjopen-2025-101046.
PubMed 40953876
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
- ClinicalTrials.gov ID
- NCT05191186
- Acronym / sponsor ID
- ILITNU / 2020-001060-28
- Conditions
- Allergic Rhinitis Due to Grass Pollen, Allergic Conjunctivitis of Both Eyes, Allergic Asthma
- Keywords
- Allergen immunotherapy, Allergic rhinoconjunctivitis, grass pollen allergy, intralymphatic immunotherapy, ILIT.NU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, University Hospital, Linkoeping
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Jan 2022 (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.
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo
Detailed description
A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects.
Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo.
Injections are giving ultrasound-guided with at least 4 weeks intervals.
To increase trial retention, two studies within the trial are conducted: a feasibility study assessing the acceptability and feasibility of a digital intervention and its evaluation design. Outcomes include participant and stakeholder acceptability, reach, mechanisms of change to improve trial retention, utilization, unintended effects, software functionality, recruitment and retention rates, questionnaire suitability, randomization feasibility, power for a future definitive trial, and initial efficacy signals. Additionally, an evaluation study assesses the efficacy of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel group, double blind placebo controlled multi site
| Arm | Type | Receives |
|---|---|---|
| grass pollen extract treatment | Active comparator | Drug: Grass pollen extract - Alutard Phleum pratense, ALKparticipants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract |
| Placebo | Placebo comparator | Drug: Grass pollen extract - Alutard Phleum pratense, ALKParticipants receive 3 injections with saline (NaCl 0.9%) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate-severe grass pollen allergic rhinoconjunctivitis
- positive skin prick test for grass pollen extract
Key exclusion criteria (8 listed)
- significant mugwort allergy
- previous AIT for grass pollen allergy
- uncontrolled non-allergic upper airways disease
- uncontrolled asthma
- planned depot steroid injections during season
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 |
|---|---|---|
| Grass pollen extract - Alutard Phleum pratense, ALKAlso: immunotherapyinjection in lymph node | Drug | Placebo, grass pollen extract treatment |
Primary outcome
Combined symptom and medication score, cSMS
Time frame: 2 years
daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo. cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use. This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication
5 secondary outcomes
side-effects
Time frame: 3 months
correlation of CSMS to pollen count
Time frame: 2 years
combined symptom and medication score, cSMS
Time frame: 2 years
Rhinitis related quality of life, RQLQ
Time frame: 2 years
Airwave oscillometry system(AOS), asthma
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 40953876Petersen AP, Schmid JM, Hoffmann HJ, Finderup J. Acceptability and feasibility of a need-supportive intervention to increase trial retention: a randomised feasibility study within a randomised controlled allergy trial in Denmark. BMJ Open. 2025 Sep 14;15(9):e101046. doi: 10.1136/bmjopen-2025-101046.
- project homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will publish data
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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. This study is not recruiting at the moment.
Johannes M Schmid, MD PhD principal investigator
Aarhus University Hospital/Aarhus University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grass pollen extract - Alutard Phleum pratense, ALK in people with Allergic Rhinitis Due to Grass Pollen and Allergic Conjunctivitis of Both Eyes, run by Aarhus University Hospital at 2 sites in 2 countries.
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 8 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: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined symptom and medication score, cSMS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191186, which also lists 1 linked publication.
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 12 Aug 2025.