Seasonal Allergic RhinitisPhase 2NCT01018693
A Study to Determine the Capacity of VAK694 When Combined With Allergen Immunotherapy to Bring About Specific Immune Tolerance
A Phase 2 study testing VAK694; Alutard Avanz SQ in people with Seasonal Allergic Rhinitis, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine whether VAK694 when combined with subcutaneous immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- VAK694; Alutard Avanz SQ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Oct 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
- No healthy volunteers
- Adult
Who may be able to join
- History of atopy, defined as a history of seasonal allergic rhinitis for at least 2 years (in relation to the grass pollen allergy season), and evidence of atopy, defined as a positive skin prick test (wheal difference allergen - negative control at least 3 mm) to grass pollen allergen at screening.
- Male or female subjects aged between 18 and 60 years (inclusive)
- Female subjects must be of non-childbearing potential
- Subjects must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive)
- Informed consent
Who cannot join
- Treatment with intranasal corticosteroids within 28 days prior to the first dose.
- History of asthma with treatment with inhaled or systemic corticosteroids within 6 months of the first dose.
- History of COPD.
- Any exposure to human monoclonal or polyclonal antibodies.
- Any allergy immunotherapy within 3 years prior to screening.
- Any prior grass pollen allergy immunotherapy.
- FEV1 < 70% of predicted at screening or baseline.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial to Determine the Capacity of VAK694 to Elicit Long Term Immune Tolerance When Combined With Subcutaneous Allergen Immunotherapy for the Treatment of Seasonal Allergic Rhinitis
The purpose of the study is to determine whether VAK694 when combined with subcutaneous immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- VAK694; Alutard Avanz SQ, VAK694 placebo infusion; Alutard Avanz SQ, VAK694 placebo infusion; Saline
- Keywords
- Seasonal allergic rhinitis,, late phase response,, alutard avanz,, immunotherapy,, visual analogue scale,, mini rhinitis quality of life,, immune modulation
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAK694; Alutard Avanz SQDrug
VAK694 placebo infusion; Alutard Avanz SQDrug
VAK694 placebo infusion; SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| VAK694 AND Immunotherapy (alutard) | Experimental | Not described Receives: Drug: VAK694; Alutard Avanz SQ |
| : VAK694 placebo AND Immunotherapy (alutard) | Experimental | Not described Receives: Drug: VAK694 placebo infusion; Alutard Avanz SQ |
| VAK694 placebo AND Immunotherapy (alutard) placebo | Experimental | Not described Receives: Drug: VAK694 placebo infusion; Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-dermal late phase response to allergen Measure: Wheal diameter
Measured: 10-12 months
Secondary outcomes (3)
To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction
Measured: 10-12 months
To assess the effects of VAK694 combined with SCIT on the symptoms of seasonal allergic rhinitis Measure: mini-Respiratory Quality of Life Questionnaire (RQLQm) and visual analogue scale (VAS)
Measured: 10-12 months
To preliminarily assess the ability of VAK694 to reduce the side-effects of subcutaneous immunotherapy Measure: Frequency and severity of local and systemic reactions to immunotherapy
Measured: 10-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 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
- NCT01018693
- Sponsor's protocol ID
- CVAK694A2205
- Status last verified
- Mar 2017
- First submitted
- 24 Nov 2009
- Last updated
- 21 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial to Determine the Capacity of VAK694 to Elicit Long Term Immune Tolerance When Combined With Subcutaneous Allergen Immunotherapy for the Treatment of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01018693
- Acronym / sponsor ID
- CVAK694A2205
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal allergic rhinitis,, late phase response,, alutard avanz,, immunotherapy,, visual analogue scale,, mini rhinitis quality of life,, immune modulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Nov 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 purpose of the study is to determine whether VAK694 when combined with subcutaneous immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VAK694 AND Immunotherapy (alutard) | Experimental | Drug: VAK694; Alutard Avanz SQ |
| : VAK694 placebo AND Immunotherapy (alutard) | Experimental | Drug: VAK694 placebo infusion; Alutard Avanz SQ |
| VAK694 placebo AND Immunotherapy (alutard) placebo | Experimental | Drug: VAK694 placebo infusion; Saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of atopy, defined as a history of seasonal allergic rhinitis for at least 2 years (in relation to the grass pollen allergy season), and evidence of atopy, defined as a positive skin prick test (wheal difference allergen - negative control at least 3 mm) to grass pollen allergen at screening.
- Male or female subjects aged between 18 and 60 years (inclusive)
- Female subjects must be of non-childbearing potential
- Subjects must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive)
- Informed consent
Key exclusion criteria (8 listed)
- Treatment with intranasal corticosteroids within 28 days prior to the first dose.
- History of asthma with treatment with inhaled or systemic corticosteroids within 6 months of the first dose.
- History of COPD.
- Any exposure to human monoclonal or polyclonal antibodies.
- Any allergy immunotherapy within 3 years prior to screening.
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 |
|---|---|---|
| VAK694; Alutard Avanz SQ | Drug | VAK694 AND Immunotherapy (alutard) |
| VAK694 placebo infusion; Alutard Avanz SQ | Drug | : VAK694 placebo AND Immunotherapy (alutard) |
| VAK694 placebo infusion; Saline | Drug | VAK694 placebo AND Immunotherapy (alutard) placebo |
Primary outcome
Intra-dermal late phase response to allergen Measure: Wheal diameter
Time frame: 10-12 months
3 secondary outcomes
To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction
Time frame: 10-12 months
To assess the effects of VAK694 combined with SCIT on the symptoms of seasonal allergic rhinitis Measure: mini-Respiratory Quality of Life Questionnaire (RQLQm) and visual analogue scale (VAS)
Time frame: 10-12 months
To preliminarily assess the ability of VAK694 to reduce the side-effects of subcutaneous immunotherapy Measure: Frequency and severity of local and systemic reactions to immunotherapy
Time frame: 10-12 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 21 Mar 2017.
- Related InfoLink 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
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 VAK694; Alutard Avanz SQ in people with Seasonal Allergic Rhinitis, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
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 8 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 21 Mar 2017. 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 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. 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?
Intra-dermal late phase response to allergen Measure: Wheal diameter (time frame: 10-12 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 21 Mar 2017.