AllergyPhase 3NCT00807547
Intraseasonal Short-time Up-dosing With Alutard SQ Grasses
A Phase 3 study testing Allergy vaccination (Alutard SQ) in people with Allergy, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- Allergy vaccination (Alutard SQ)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Jan 2009
- 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
- history of grass pollen induced allergic rhinoconjunctivitis
- positive skin prick test
Who cannot join
- uncontrolled severe bronchial asthma
- previous treatment with immunotherapy within the previous 5 years
- contraindication for specific immunotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
- Conditions
- Allergy
- Being tested
- Allergy vaccination (Alutard SQ)
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergy vaccination (Alutard SQ)Biological
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
| Study group | Role | What they receive |
|---|---|---|
| Allergy vaccination | Active comparator | Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals Receives: Biological: Allergy vaccination (Alutard SQ) |
| Subcutaneous injections | Placebo comparator | Placebo injections Receives: Biological: Allergy vaccination (Alutard SQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Immuno globuline E (IgE)-blocking factor
Measured: 9 weeks
Secondary outcomes (1)
Tolerability
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionJan 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 AllergyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludger Klimek, MD, Principal investigator, Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807547
- Sponsor's protocol ID
- SHX0562
- Status last verified
- Dec 2015
- First submitted
- 30 Sep 2008
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pfaar O, Wolf H, Klimek L, Schnitker J, Wustenberg E. Immunologic effect and tolerability of intra-seasonal subcutaneous immunotherapy with an 8-day up-dosing schedule to 10,000 standardized quality-units: a double-blind, randomized, placebo-controlled trial. Clin Ther. 2012 Oct;34(10):2072-81. doi: 10.1016/j.clinthera.2012.09.006.
PubMed 23063373
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ
- ClinicalTrials.gov ID
- NCT00807547
- Acronym / sponsor ID
- SHX0562
- Conditions
- Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 Dec 2008 (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.
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergy vaccination | Active comparator | Biological: Allergy vaccination (Alutard SQ)Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals |
| Subcutaneous injections | Placebo comparator | Biological: Allergy vaccination (Alutard SQ)Placebo injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history of grass pollen induced allergic rhinoconjunctivitis
- positive skin prick test
Key exclusion criteria (3 listed)
- uncontrolled severe bronchial asthma
- previous treatment with immunotherapy within the previous 5 years
- contraindication for specific immunotherapy
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 |
|---|---|---|
| Allergy vaccination (Alutard SQ)Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days | Biological | Allergy vaccination, Subcutaneous injections |
Primary outcome
Changes from baseline in Immuno globuline E (IgE)-blocking factor
Time frame: 9 weeks
1 secondary outcome
Tolerability
Time frame: 9 weeks
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 29 Dec 2015.
- Results publication: PubMed 23063373Pfaar O, Wolf H, Klimek L, Schnitker J, Wustenberg E. Immunologic effect and tolerability of intra-seasonal subcutaneous immunotherapy with an 8-day up-dosing schedule to 10,000 standardized quality-units: a double-blind, randomized, placebo-controlled trial. Clin Ther. 2012 Oct;34(10):2072-81. doi: 10.1016/j.clinthera.2012.09.006.
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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.
Ludger Klimek, MD principal investigator
Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allergy vaccination (Alutard SQ) in people with Allergy, 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 2 inclusion and 3 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 29 Dec 2015. 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. 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?
Changes from baseline in Immuno globuline E (IgE)-blocking factor (time frame: 9 weeks). 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 NCT00807547, 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 29 Dec 2015.