Rhinitis, Allergic, SeasonalPhase 2/3NCT02975479
Intralymphatic Immunotherapy in Increasing Doses, Substudy
A Phase 2/3 study testing ALK Diluent and ALK Alutard SQ 5-grasses or ALK Alutard Birch in people with Rhinitis, Allergic, Seasonal, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- ALK Diluent and ALK Alutard SQ 5-grasses or ALK Alutard Birch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- May 2016to 20 Jun 2022
- 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
- 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
2 sites in 1 country.
Sweden2 sites
Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
Lund, 221 85
ENT-department, Karolinska University Hospital Huddinge (ENT-department B51)
Stockholm, 141 86
About this study
Official title: Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U - a Human Randomized Clinical Trial. Substudy.
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
*IMPORTANT INFORMATION!* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
Read the detailed description
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- ALK Diluent, ALK Alutard SQ 5-grasses or ALK Alutard Birch
- Keywords
- Hay fever, Pollen allergy, Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK DiluentDrug
Also called 0,3% human albumin. ATC-code V07AB
ALK Alutard SQ 5-grasses or ALK Alutard BirchDrug
Also called Allergen, grass pollen. ATC-code V01AA02 or V01AA05
Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.
| Study group | Role | What they receive |
|---|---|---|
| Intralymphatic placebo injections | Placebo comparator | ALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval. Receives: Drug: ALK Diluent |
| Intralymphatic active injections | Active comparator | ATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U.
*IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. * Receives: Drug: ALK Alutard SQ 5-grasses or ALK Alutard Birch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean combined daily symptoms-and-medications-score
Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
Measured: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Secondary outcomes (8)
Mean total daily symptoms score
Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale)
Measured: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Mean total daily medications score
Daily scoring of medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
Measured: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Change in subjective allergic symptoms following nasal allergen provocation
The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation.
Measured: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
Effects on quality of life
Juniper Rhinitis quality of life questionnaire (RQLQ) questionnaires
Measured: During peak pollen season which will be up to 6 months after completed treatment.
Short term change of skin reactivity
Skin prick test
Measured: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
S-IgE Grass or Birch
Measured: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
S-IgG4 Grass or Birch
Measured: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Registration of adverse event
Measured: From the first injection to 30 days after the last injections has been given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMay 2016
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
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 Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital, Karolinska University Hospital
- Responsible party
- Principal investigator, Lars Olaf Cardell, Karolinska Institutet
- Investigators
- Lars-Olaf Cardell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975479
- Sponsor's protocol ID
- 2015-001259-63 substudy
- Other IDs
- 2015
- Status last verified
- Oct 2020
- First submitted
- 24 Nov 2016
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29.
PubMed 34379802
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U - a Human Randomized Clinical Trial. Substudy.
- ClinicalTrials.gov ID
- NCT02975479
- Acronym / sponsor ID
- 2015-001259-63 substudy
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Hay fever, Pollen allergy, Allergic rhinitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Skane University Hospital, Karolinska University Hospital
- Study start
- May 2016
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.
*IMPORTANT INFORMATION!* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
Detailed description
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.
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 |
|---|---|---|
| Intralymphatic placebo injections | Placebo comparator | Drug: ALK DiluentALK Diluent, ATC-code V07AB. 3 injections with 4-7 weeks interval. |
| Intralymphatic active injections | Active comparator | Drug: ALK Alutard SQ 5-grasses or ALK Alutard BirchATC-code V01AA02. 3 injections with 4-7 weeks interval in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U, 10000 SQ-U. *IMPORTANT INFORMATION! The up-dosing protocol is changed due to an adverse event at the last injection. New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U. * |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 DiluentAlso: 0,3% human albumin. ATC-code V07AB | Drug | Intralymphatic placebo injections |
| ALK Alutard SQ 5-grasses or ALK Alutard BirchAlso: Allergen, grass pollen. ATC-code V01AA02 or V01AA05Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension. | Drug | Intralymphatic active injections |
Primary outcome
Mean combined daily symptoms-and-medications-score
Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Daily scoring of rhinoconjunctivitis symptoms (6 questions, 4-point scale) and medication use (oral or topical antihistamines, intranasal corticosteroids, oral corticosteroids).
8 secondary outcomes
Mean total daily symptoms score
Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Mean total daily medications score
Time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).
Change in subjective allergic symptoms following nasal allergen provocation
Time frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
Effects on quality of life
Time frame: During peak pollen season which will be up to 6 months after completed treatment.
Short term change of skin reactivity
Time frame: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.
S-IgE Grass or Birch
Time frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
S-IgG4 Grass or Birch
Time frame: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment
Registration of adverse event
Time frame: From the first injection to 30 days after the last injections has been given
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 Jun 2022.
- Derived from this study: PubMed 34379802Hellkvist L, Hjalmarsson E, Weinfeld D, Dahl A, Karlsson A, Westman M, Lundkvist K, Winqvist O, Georen SK, Westin U, Cardell LO. High-dose pollen intralymphatic immunotherapy: Two RDBPC trials question the benefit of dose increase. Allergy. 2022 Mar;77(3):883-896. doi: 10.1111/all.15042. Epub 2021 Aug 29.
- Individual participant dataSharing planned: Undecided
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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
2 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 ALK Diluent and ALK Alutard SQ 5-grasses or ALK Alutard Birch in people with Rhinitis, Allergic, Seasonal, run by Karolinska Institutet at 2 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 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 Jun 2022. 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 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?
Mean combined daily symptoms-and-medications-score (time frame: Peak pollen season (approximately 6 months after completed treatment) and entire pollen season (5-7 months after treatment).). 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 NCT02975479, 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 24 Jun 2022.