Allergic RhinitisPhase 2NCT00584584
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
A Phase 2 study testing QAX576 in people with Allergic Rhinitis, run by Novartis at 2 sites in 2 countries.
Trial summary
This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- QAX576
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2007to Aug 2008
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of allergic rhinitis.
Who cannot join
- Respiratory disease other than mild intermittent asthma.
- Received immunotherapy in past 3 years.
- History of clinically significant drug allergy.
- History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
- History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen
This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever
- Conditions
- Allergic Rhinitis
- Being tested
- QAX576, Placebo
- Keywords
- Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: QAX576 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
Measured: throughout the study
Secondary outcomes (1)
- Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2008
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- NOVARTIS, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584584
- Sponsor's protocol ID
- CQAX576A2104
- Status last verified
- Feb 2017
- First submitted
- 21 Dec 2007
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen
- ClinicalTrials.gov ID
- NCT00584584
- Acronym / sponsor ID
- CQAX576A2104
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 2 Jan 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.
This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QAX576 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- History of allergic rhinitis.
Key exclusion criteria (6 listed)
- Respiratory disease other than mild intermittent asthma.
- Received immunotherapy in past 3 years.
- History of clinically significant drug allergy.
- History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
- History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.
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 |
|---|---|---|
| QAX576 | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
Time frame: throughout the study
1 secondary outcome
- Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose.
Time frame: throughout the study
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 Feb 2017.
- Results of CQAX576A2104 from United European Gastroenterology journalLink provided by the sponsor.
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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.
NOVARTIS principal investigator
Novartis investigator site
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAX576 in people with Allergic Rhinitis, run by Novartis at 2 sites in 2 countries.
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 1 inclusion and 6 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 Feb 2017. 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 Germany, United Kingdom. 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 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?
Markers of allergic inflammation in the nose measured over 5-8 days post-dose. (time frame: throughout the study). 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 24 Feb 2017.