RhinitisPhase 2NCT00857779
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
A Phase 2 study testing subcutaneous immunotherapy in people with Rhinitis and Conjunctivitis, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Conjunctivitis, Asthma
- What is being tested?
- subcutaneous immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Oct 2009
- Phase
- Phase 2
- 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
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- Lack of adequate relief with symptomatic medication during the previous grass pollen season
- Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening
Who cannot join
- FEV1 < 70% of predicted value at screening
- Bronchial asthma corresponding to GINA step 3 or more, even if controlled
- History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
- Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
- Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ
Trial locations and contacts
1 site in 1 country.
Germany1 site
Allergists' practice Dr. Kirsten Jung
Erfurt, Thuringia, D-99084
About this study
Official title: A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ
The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ
- Conditions
- Rhinitis, Conjunctivitis, Asthma
- Being tested
- subcutaneous immunotherapy
- Keywords
- allergen immunotherapy, allergy to grass pollen
- Medical subject headings
- Rhinitis, Conjunctivitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous immunotherapyBiological
Also called AVANZ
7 injections
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous immunotherapy | Active comparator | subcutaneous immunotherapy using a slow updosing schedule Receives: Biological: subcutaneous immunotherapy |
| subcutaneous injections | Active comparator | subcutaneous immunotherapy using a fast updosing schedule Receives: Biological: subcutaneous immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgE-blocking factor
Measured: start of treatment and 1 week after end of treatment
Secondary outcomes (1)
Tolerability of two different updosing schedules
Measured: throughout treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionOct 2009
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 RhinitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsten Jung, MD, Principal investigator, Private practice, Erfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857779
- Sponsor's protocol ID
- AF-H-01
- Status last verified
- Feb 2013
- First submitted
- 5 Mar 2009
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wustenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 May;67(5):630-7. doi: 10.1111/j.1398-9995.2012.02801.x. Epub 2012 Mar 3.
PubMed 22385366
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ
- ClinicalTrials.gov ID
- NCT00857779
- Acronym / sponsor ID
- AF-H-01
- Conditions
- Rhinitis, Conjunctivitis, Asthma
- Keywords
- allergen immunotherapy, allergy to grass pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Mar 2009 (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 aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcutaneous immunotherapy | Active comparator | Biological: subcutaneous immunotherapysubcutaneous immunotherapy using a slow updosing schedule |
| subcutaneous injections | Active comparator | Biological: subcutaneous immunotherapysubcutaneous immunotherapy using a fast updosing schedule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- Lack of adequate relief with symptomatic medication during the previous grass pollen season
- Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening
Key exclusion criteria (5 listed)
- FEV1 < 70% of predicted value at screening
- Bronchial asthma corresponding to GINA step 3 or more, even if controlled
- History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months
- Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
- Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ
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 |
|---|---|---|
| subcutaneous immunotherapyAlso: AVANZ7 injections | Biological | subcutaneous immunotherapy, subcutaneous injections |
Primary outcome
IgE-blocking factor
Time frame: start of treatment and 1 week after end of treatment
1 secondary outcome
Tolerability of two different updosing schedules
Time frame: throughout treatment
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 8 Feb 2013.
- Results publication: PubMed 22385366Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wustenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 May;67(5):630-7. doi: 10.1111/j.1398-9995.2012.02801.x. Epub 2012 Mar 3.
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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.
Kirsten Jung, MD principal investigator
Private practice, Erfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing subcutaneous immunotherapy in people with Rhinitis and Conjunctivitis, run by ALK-Abelló A/S at 1 site in Germany.
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 5 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 8 Feb 2013. 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 Germany. 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 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.
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?
IgE-blocking factor (time frame: start of treatment and 1 week after end of 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 NCT00857779, 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 8 Feb 2013; AzTrials last refreshed its copy on 30 Oct 2026.