Allergic RhinitisPhase 2SUMMITNCT01728298
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy
A Phase 2 study testing SLITone ULTRA HDM immunotherapy in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in France.
Trial summary
The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- SLITone ULTRA HDM immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Aug 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Moderate to severe persistent HDM allergic rhinitis with or without asthma
- Moderate to severe HDM allergic rhinitis symptoms during a baseline period
- Positive skin prick test response (wheal diameter ≥ 3 mm)
- Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)
Who cannot join
- Previous treatment with immunotherapy with House dust mite immunotherapy
- Ongoing treatment with any allergen specific immunotherapy product
- Reduced lung function
- Clinical history of uncontrolled asthma
- Inflammatory conditions in the oral cavity with severe symptoms
- History of anaphylaxis with cardiorespiratory symptoms
Show all 12Show fewer
- History of recurrent generalised urticaria
- A history of drug induced facial angioedema or hereditary angiooedema
- Any clinically relevant chronic disease (≥3 months duration)
- Systemic disease affecting the immune system
- Immunosuppressive treatment
- Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- SLITone ULTRA HDM immunotherapy
- Keywords
- House Dust Mite, allergy, rhinitis, asthma
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity, Rhinitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLITone ULTRA HDM immunotherapyBiological
| Study group | Role | What they receive |
|---|---|---|
| SLITone ULTRA low dose | Active comparator | SLITone ULTRA HDM immunotherapy Receives: Biological: SLITone ULTRA HDM immunotherapy |
| SLITone ULTRA medium dose | Active comparator | SLITone ULTRA HDM immunotherapy Receives: Biological: SLITone ULTRA HDM immunotherapy |
| SLITone ULTRA high dose | Active comparator | SLITone ULTRA HDM immunotherapy Receives: Biological: SLITone ULTRA HDM immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in IgE-blocking factor after 6 months of treatment
Measured: 6 months
Secondary outcomes (1)
Number of subjects with treatment related adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Didier, Pr., Principal investigator, Hôpital Larrey, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728298
- Sponsor's protocol ID
- SU-M-01
- Acronym
- SUMMIT
- Status last verified
- Jan 2014
- First submitted
- 2 Nov 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial
- ClinicalTrials.gov ID
- NCT01728298
- Acronym / sponsor ID
- SUMMIT / SU-M-01
- Conditions
- Allergic Rhinitis
- Keywords
- House Dust Mite, allergy, rhinitis, asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Nov 2012 (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 primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLITone ULTRA low dose | Active comparator | Biological: SLITone ULTRA HDM immunotherapySLITone ULTRA HDM immunotherapy |
| SLITone ULTRA medium dose | Active comparator | Biological: SLITone ULTRA HDM immunotherapySLITone ULTRA HDM immunotherapy |
| SLITone ULTRA high dose | Active comparator | Biological: SLITone ULTRA HDM immunotherapySLITone ULTRA HDM immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 or older
- Moderate to severe persistent HDM allergic rhinitis with or without asthma
- Moderate to severe HDM allergic rhinitis symptoms during a baseline period
- Positive skin prick test response (wheal diameter ≥ 3 mm)
- Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)
Key exclusion criteria (12 listed)
- Previous treatment with immunotherapy with House dust mite immunotherapy
- Ongoing treatment with any allergen specific immunotherapy product
- Reduced lung function
- Clinical history of uncontrolled asthma
- Inflammatory conditions in the oral cavity with severe symptoms
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 |
|---|---|---|
| SLITone ULTRA HDM immunotherapy | Biological | SLITone ULTRA high dose, SLITone ULTRA low dose, SLITone ULTRA medium dose |
Primary outcome
Change from baseline in IgE-blocking factor after 6 months of treatment
Time frame: 6 months
1 secondary outcome
Number of subjects with treatment related adverse events
Time frame: 6 months
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 22 Jan 2014.
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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.
Alain Didier, Pr. principal investigator
Hôpital Larrey, Toulouse
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 SLITone ULTRA HDM immunotherapy in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in France.
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 5 inclusion and 12 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 22 Jan 2014. 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 France. 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?
Change from baseline in IgE-blocking factor after 6 months of treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2014.