AsthmaPhase 1NCT01568762
To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
A Phase 1 study testing VAK694 and QAX576 in people with Asthma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- VAK694 and QAX576
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2011
- Phase
- Phase 1
- 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
- Male and female subjects age 18-60 years (inclusive)
- Well controlled mild to moderate atopic asthma
- Female subjects must be post-menopausal or surgically sterile
- Male subjects must be using two methods of contraception
- Subjects must have a positive skin prick test to one or more common airborne allergen
Who cannot join
- Participation in any clinical investigation or use of other investigational drugs at time of enrollment
- A history of clinically significant ECG abnormalities
- History of malignancy of any organ system
- Smokers (use of tobacco products in the previous 3 months)
- Use of prescription drugs other than those required for control and relief of asthma
- Use of oral steroids within 12 weeks prior to dosing
Show all 15Show fewer
- FEVI < 80% predicted at screening or baseline
- Use of albuterol more than twice a week for relief of asthma
- Patients suffering from active hay fever at baseline or likely to require treatment during the study
- History of chronic respiratory disease other than asthma or chronic allergic rhinitis
- Emergency room visit within 6 weeks of screening due to asthma
- Hospitalization for asthma in the last year
- History of intubation/assisted ventilation for asthma in the last 5 years
- Administration of live vaccines within the preceding month
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Raleigh, North Carolina, 27607
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 (Sequential Administration of a Fixed Dose of VAK694 and Single Ascending Doses of QAX576) in Patients With Well-controlled Mild to Moderate Asthma
This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.
- Conditions
- Asthma
- Being tested
- VAK694, VAK694 placebo, QAX576, QAX576 placebo
- Keywords
- Asthma, VAK694, QAX576, QBX258, pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAK694Drug
Intravenous infusion
VAK694 placeboDrug
Intravenous infusion
QAX576Drug
Intravenous infusion
QAX576 placeboDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| VAK694 | Experimental | VAK694 was administered as a 1 hour intravenous infusion Receives: Drug: VAK694 |
| VAK694 Placebo | Placebo comparator | VAK694 placebo was administered as a one hour intravenous infusion Receives: Drug: VAK694 placebo |
| QAX576 | Experimental | QAX576 was administered intravenously as a 2 hour infusion Receives: Drug: QAX576 |
| QAX576 placebo | Placebo comparator | QAX576 placebo was administered as a 2 hour intravenous infusion Receives: Drug: QAX576 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs
Measured: 100 days
Secondary outcomes (5)
Concentration of serum anti-VAK694 antibodies
Blood will be collected to determine concentrations if anti-VAK964 antibodies
Measured: Pre-dose, Day 71, 85 and 100
Concentration of serum anti-QAX576 antibodies
Blood will be collected to determine concentrations if anti-QAX576 antibodies
Measured: Pre-dose, Day 71, 85 and 100
Area under the serum concentration curve for VAK694
Blood will be collected for the measurement of VAK694 serum concentrations
Measured: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Area under the serum concentration curve for QAX576
Blood will be collected for the measurement of QAX576 concentrations
Measured: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Change in interleukin concentrations
Blood samples will be collected to measure interleukin concetrations.
Measured: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- NCT01568762
- Sponsor's protocol ID
- CQBX258X2101
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 (Sequential Administration of a Fixed Dose of VAK694 and Single Ascending Doses of QAX576) in Patients With Well-controlled Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT01568762
- Acronym / sponsor ID
- CQBX258X2101
- Conditions
- Asthma
- Keywords
- Asthma, VAK694, QAX576, QBX258, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- First posted
- 2 Apr 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.
This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VAK694 | Experimental | Drug: VAK694VAK694 was administered as a 1 hour intravenous infusion |
| VAK694 Placebo | Placebo comparator | Drug: VAK694 placeboVAK694 placebo was administered as a one hour intravenous infusion |
| QAX576 | Experimental | Drug: QAX576QAX576 was administered intravenously as a 2 hour infusion |
| QAX576 placebo | Placebo comparator | Drug: QAX576 placeboQAX576 placebo was administered as a 2 hour intravenous infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects age 18-60 years (inclusive)
- Well controlled mild to moderate atopic asthma
- Female subjects must be post-menopausal or surgically sterile
- Male subjects must be using two methods of contraception
- Subjects must have a positive skin prick test to one or more common airborne allergen
Key exclusion criteria (15 listed)
- Participation in any clinical investigation or use of other investigational drugs at time of enrollment
- A history of clinically significant ECG abnormalities
- History of malignancy of any organ system
- Smokers (use of tobacco products in the previous 3 months)
- Use of prescription drugs other than those required for control and relief of asthma
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 |
|---|---|---|
| VAK694Intravenous infusion | Drug | VAK694 |
| VAK694 placeboIntravenous infusion | Drug | VAK694 Placebo |
| QAX576Intravenous infusion | Drug | QAX576 |
| QAX576 placeboIntravenous infusion | Drug | QAX576 placebo |
Primary outcome
Number of patients with adverse events
Time frame: 100 days
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs
5 secondary outcomes
Concentration of serum anti-VAK694 antibodies
Time frame: Pre-dose, Day 71, 85 and 100
Concentration of serum anti-QAX576 antibodies
Time frame: Pre-dose, Day 71, 85 and 100
Area under the serum concentration curve for VAK694
Time frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Area under the serum concentration curve for QAX576
Time frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Change in interleukin concentrations
Time frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
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 Dec 2020.
- Results forCQBX258X2101 can be found on the Novartis Clinical Trial Results 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VAK694 and QAX576 in people with Asthma, run by Novartis Pharmaceuticals at 1 site in United States.
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 15 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 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 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of patients with adverse events (time frame: 100 days). 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 Dec 2020.