Allergic RhinitisPhase 2NCT00929968
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis
A Phase 2 study testing VAK694 and Fluticasone in people with Allergic Rhinitis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- VAK694 and Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2009to Feb 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects between ages of 18 to 60 in good health
- History of atopy for at least 2 years and positive skin prick test to ragweed allergen
Who cannot join
- History of asthma treated with corticosteroids
- Smokers with a smoking history of > 10 pack/years or smoking in the past year
- History of chronic obstructive pulmonary disease
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
About this study
Official title: A Randomized, Double-blind, Placebo and Calibrator Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Doses of VAK694 in Subjects With Seasonal Rhinitis During Natural Exposure to Allergen
This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis
- Conditions
- Allergic Rhinitis
- Being tested
- Placebo, VAK694, Fluticasone
- Keywords
- Allergic rhinitis,, atopic patients,, seasonal allergy,, ragweed allergy
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
VAK694Biological
FluticasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo to VAK694 | Placebo comparator | Not described Receives: Biological: Placebo |
| VAK694 | Experimental | Not described Receives: Biological: VAK694 |
| Fluticasone propionate | Active comparator | Not described Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects
Measured: 12 weeks
Secondary outcomes (5)
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects
Measured: 12 weeks
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG
Measured: 12 weeks
Immunogenicity of multiple intravenous doses of VAK694
Measured: 12 weeks
Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.
Measured: 12 weeks
Changes in biomarkers of immunomodulation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929968
- Sponsor's protocol ID
- CVAK694A2201
- Status last verified
- May 2012
- First submitted
- 29 Jun 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo and Calibrator Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Doses of VAK694 in Subjects With Seasonal Rhinitis During Natural Exposure to Allergen
- ClinicalTrials.gov ID
- NCT00929968
- Acronym / sponsor ID
- CVAK694A2201
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis,, atopic patients,, seasonal allergy,, ragweed allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- First posted
- 30 Jun 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.
This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo to VAK694 | Placebo comparator | Biological: Placebo |
| VAK694 | Experimental | Biological: VAK694 |
| Fluticasone propionate | Active comparator | Drug: Fluticasone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female subjects between ages of 18 to 60 in good health
- History of atopy for at least 2 years and positive skin prick test to ragweed allergen
Key exclusion criteria (4 listed)
- History of asthma treated with corticosteroids
- Smokers with a smoking history of > 10 pack/years or smoking in the past year
- History of chronic obstructive pulmonary disease
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Placebo | Biological | Placebo to VAK694 |
| VAK694 | Biological | VAK694 |
| Fluticasone | Drug | Fluticasone propionate |
Primary outcome
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects
Time frame: 12 weeks
5 secondary outcomes
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects
Time frame: 12 weeks
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG
Time frame: 12 weeks
Immunogenicity of multiple intravenous doses of VAK694
Time frame: 12 weeks
Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.
Time frame: 12 weeks
Changes in biomarkers of immunomodulation
Time frame: 12 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 19 Dec 2020.
- Results for CVAK694A2201 from the Novartis Clinical Trials websiteLink 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 Pharmaceuticals study director
Novartis Pharmaceuticals
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 VAK694 and Fluticasone in people with Allergic Rhinitis, run by Novartis Pharmaceuticals 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 2 inclusion and 4 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 19 Dec 2020. 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 United States, Canada. 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?
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects (time frame: 12 weeks). 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 19 Dec 2020.