Allergic Rhinitis Due to Grass PollenPhase 2/3NCT04210193
Is Intralymphatic Allergen Immunotherapy Effective and Safe?
A Phase 2/3 study testing ALK Alutard 5-grasses and ALK Diluent in people with Allergic Rhinitis Due to Grass Pollen, run by Lars Olaf Cardell at 1 site in Sweden.
Trial summary
15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollen
- What is being tested?
- ALK Alutard 5-grasses and ALK Diluent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 25 Apr 2014to 1 Dec 2019
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50,
- Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
- Accepted informed consent
Who cannot join
- Pregnancy or nursing
- Autoimmune or collagen disease (known)
- Cardiovascular disease
- Perennial pulmonary disease
- Hepatic disease
- Renal disease
Show all 17Show fewer
- Cancer
- Any medication with a possible side-effect of interfering with the immune response
- Previous immuno- or chemotherapy
- Chronic diseases
- Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)
- Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
- Major metabolic disease
- Known or suspected allergy to the study product
- Alcohol or drug abuse
- Mental incapability of coping with the study
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster
15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.
Read the detailed description
The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.
The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.
The first part of the study is completed and published (PMID: 23374268)
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Being tested
- ALK Alutard 5-grasses, ALK Diluent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK Alutard 5-grassesDrug
Also called Grass allergen with aluminum adjuvant
0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
ALK DiluentDrug
Also called Human albumin
0.1 mL of ALK Diluent as an intralymphatic injection
| Study group | Role | What they receive |
|---|---|---|
| Active booster | Active comparator | After three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment. Receives: Drug: ALK Alutard 5-grasses |
| Placebo booster | Placebo comparator | After three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment. Receives: Drug: ALK Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the serum-level of timothy specific IgG4 after 1 month
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Measured: Change between baseline and 1 month after treatment.
Change in the serum-level of timothy specific IgG4 after 9 months
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Measured: Change between baseline and 9 months after treatment.
Change in the serum-level of timothy specific IgG4 2 months after booster
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Measured: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Change in the serum-level of timothy specific IgG4 10 months after booster
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Measured: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start25 Apr 2014
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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.
- 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
- 15 participants (actual)
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 Olaf Cardell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210193
- Sponsor's protocol ID
- ILIT Borås EPN 2014/251
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georen S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9.
PubMed 26817454Konradsen JR, Grundstrom J, Hellkvist L, Tran TAT, Andersson N, Gafvelin G, Kiewiet MBG, Hamsten C, Tang J, Parkin RV, Shamji MH, Hedlin G, Cardell LO, van Hage M. Intralymphatic immunotherapy in pollen-allergic young adults with rhinoconjunctivitis and mild asthma: A randomized trial. J Allergy Clin Immunol. 2020 Mar;145(3):1005-1007.e7. doi: 10.1016/j.jaci.2019.11.017. Epub 2019 Nov 24. No abstract available.
PubMed 31775016Weinfeld D, Westin U, Hellkvist L, Mellqvist UH, Jacobsson I, Cardell LO. A preseason booster prolongs the increase of allergen specific IgG4 levels, after basic allergen intralymphatic immunotherapy, against grass pollen seasonal allergy. Allergy Asthma Clin Immunol. 2020 Apr 28;16:31. doi: 10.1186/s13223-020-00427-z. eCollection 2020.
PubMed 32368217
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster
- ClinicalTrials.gov ID
- NCT04210193
- Acronym / sponsor ID
- ILIT Borås EPN 2014/251
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lars Olaf CardellUniversity, hospital or other
- Study start
- 25 Apr 2014 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Dec 2019 (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.
15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.
Detailed description
The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.
The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.
The first part of the study is completed and published (PMID: 23374268)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active booster | Active comparator | Drug: ALK Alutard 5-grassesAfter three basic open label grass allergen ILIT injections the patient is randomized to an active ILIT booster 1 year after the first treatment. |
| Placebo booster | Placebo comparator | Drug: ALK DiluentAfter three basic open label grass allergen ILIT injections the patient is randomized to a placebo ILIT booster 1 year after the first treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50,
- Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
- Accepted informed consent
Key exclusion criteria (17 listed)
- Pregnancy or nursing
- Autoimmune or collagen disease (known)
- Cardiovascular disease
- Perennial pulmonary disease
- Hepatic disease
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 |
|---|---|---|
| ALK Alutard 5-grassesAlso: Grass allergen with aluminum adjuvant0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection | Drug | Active booster |
| ALK DiluentAlso: Human albumin0.1 mL of ALK Diluent as an intralymphatic injection | Drug | Placebo booster |
Primary outcome
Change in the serum-level of timothy specific IgG4 after 1 month
Time frame: Change between baseline and 1 month after treatment.
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 after 9 months
Time frame: Change between baseline and 9 months after treatment.
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 2 months after booster
Time frame: Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).
Blood samples with measurement of allergen specific blocking IgG4 antibodies
Change in the serum-level of timothy specific IgG4 10 months after booster
Time frame: Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).
Blood samples with measurement of allergen specific blocking IgG4 antibodies
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 24 Dec 2019.
- Background: PubMed 26817454Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georen S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9.
- Background: PubMed 31775016Konradsen JR, Grundstrom J, Hellkvist L, Tran TAT, Andersson N, Gafvelin G, Kiewiet MBG, Hamsten C, Tang J, Parkin RV, Shamji MH, Hedlin G, Cardell LO, van Hage M. Intralymphatic immunotherapy in pollen-allergic young adults with rhinoconjunctivitis and mild asthma: A randomized trial. J Allergy Clin Immunol. 2020 Mar;145(3):1005-1007.e7. doi: 10.1016/j.jaci.2019.11.017. Epub 2019 Nov 24. No abstract available.
- Derived from this study: PubMed 32368217Weinfeld D, Westin U, Hellkvist L, Mellqvist UH, Jacobsson I, Cardell LO. A preseason booster prolongs the increase of allergen specific IgG4 levels, after basic allergen intralymphatic immunotherapy, against grass pollen seasonal allergy. Allergy Asthma Clin Immunol. 2020 Apr 28;16:31. doi: 10.1186/s13223-020-00427-z. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Lars Olaf Cardell, Professor principal investigator
Karolinska Institutet
1 site 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 ALK Alutard 5-grasses and ALK Diluent in people with Allergic Rhinitis Due to Grass Pollen, run by Lars Olaf Cardell at 1 site 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 3 inclusion and 17 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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?
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?
Change in the serum-level of timothy specific IgG4 after 1 month (time frame: Change between baseline and 1 month after treatment.). The study lists 4 primary outcomes in all. 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 NCT04210193, which also lists 3 linked publications.
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 24 Dec 2019; AzTrials last refreshed its copy on 26 Oct 2026.