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Allergic RhinitisPhase 2/3NCT02423707

Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy

A Phase 2/3 study testing ALK Alutard Birch and/or 5-grasses and ALK Diluent in people with Allergic Rhinitis, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the long-term development of allergic rhinitis and asthma. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
ALK Alutard Birch and/or 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
110 participants
Where
1 siteSweden
Study dates
Aug 2010to Dec 2017
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 50 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.

Sweden1 site

  • Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö

    Malmö, 20502

Other trials in Sweden

About this study

Official title: Intralymphatic Allergen-specific Immunity as a New Administration Route for Treatment of Pollen-induced Allergic Diseases

Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT requires numerous subcutaneous allergen injections and takes several years to complete. Hence, there is a need to develop more convenient protocols for induction of allergen tolerance.

Emerging evidence suggest that by targeting of antigen presenting cells within the lymph nodes the immunogenicity of the allergen can be enhanced and the number of injections can be reduced.

Read more

The purpose of this study is to evaluate whether intralymphatic administration of ASIT 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 investigators will make an attempt to reproduce the results of a recent human study of intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting.

The first part of the study is completed and published (PMID: 23374268)

Read the detailed description

In the first part of the study safety and clinical efficacy of ALK Alutard Birch or 5-grass have been evaluated in a RCT with 50 patients. Active patients recieve 3 injections with 1000 SQ-U ALK Alutard or 5-grasses in a lymph node in the groin. Dose interval 4 weeks. This part of the study is completed and published (PMID: 23374268)

In the second part of the study 60 patients participates in a RCT with intralymphatic injections with both ALK Alutard Birch AND ALK Alutard 5-grasses. The injections are given intralymphatically with one allergen in each groin with 30 minutes observation between injections. Dose and dose interval are the same as in the first part of the study; the active group recieves 1000 SQ-U ALK Alutard Birch in right groin and 1000 SQ-U 5-grasses in left groin. The injections are given 3 times with 4 weeks interval. Enrollment and treatment is completed and the results will be evaluated in the autumn 2015.

Being tested
ALK Alutard Birch and/or 5-grasses, ALK Diluent
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALK Alutard Birch and/or 5-grassesDrug

    Also called ALK Alutard Betula Verrucosa and ALK Alutard 5-grasses

    3 intralymphatic injections of 1000 SQ-U birch and/or grass allergen with 4 weeks interval.

    The substance used for the three intralymphatic injections is ALK-alutard SQ Betula verrucosa® and ALK-alutard SQ 5-grasses ® under ATC-code V01AA, V04CL and V07AB which is a depot formulation for subcutaneous use.

  • ALK DiluentDrug

    Also called Human albumin

    This placebo group will receive 3 injections of 0.3% human albumin instead of active substance

Study groups in NCT02423707
Study groupRoleWhat they receive
ALK Alutard Birch and/or 5-grassesActive comparator3 intralymphatic injections with dose 1000 SQ-U and dose interval 4 weeks.
Receives: Drug: ALK Alutard Birch and/or 5-grasses
ALK diluentPlacebo comparator3 intralymphatic injections with dose interval 4 weeks.
Receives: Drug: ALK Diluent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

Secondary outcomes (10)

  1. Registration of adverse event

    Measured: from the first injection to 30 days after the last injections has been given

  2. Effects on quality of life

    SNOT-22 questionnaire

    Measured: During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment

  3. Effects on quality of life

    Juniper RQLQ questionnaires

    Measured: During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment

  4. Change in medicine consumption during pollen season

    After the pollen season patients report to what extension they have been using medications; more, the same or less. The mediacations asked about are antihistamine tablets, antihistamine eye drops, nasal steroid, steroid tablets, b2-bronchodilator inhalation, leucotrien receptor antagonist, nasal or ocular sodium chromoglycates.

    Measured: 6-9 months after treatment.

  5. Change in symptoms at pollen season

    After the pollen season at the 6-9 months follow up patients recall the pollen season and rates the improvement on an arbitrary scale ranging 0-10 with 0 as "no improvement at all" and 10 "total symptom relief".

    Measured: 6-9 months after treatment.

  6. Short term improvement of skin reactivity

    Skin prick test

    Measured: Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment.

  7. S-IgE Birch

    Measured: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment

  8. S-IgE Grass

    Measured: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment

  9. S-IgG4 Grass

    Measured: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment

  10. S-IgG4 Birch

    Measured: Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2015 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2015
  4. Study completionDec 2017

Resources

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
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02423707
Sponsor's protocol ID
2009-016815-39
Other IDs
2009
Status last verified
Aug 2018
First submitted
28 Mar 2012
Last updated
20 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

    PubMed 19001265

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ALK Alutard Birch and/or 5-grasses and ALK Diluent in people with Allergic Rhinitis, run by Karolinska Institutet 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 20 Aug 2018. 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 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.). 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 NCT02423707, 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 20 Aug 2018.

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