AsthmaPhase 2NCT01479595

A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

A Phase 2 study testing QBX258 in people with Asthma, run by Novartis Pharmaceuticals at 20 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: QBX258
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 20 sitesin 3 countries
Study dates: Feb 2012to Feb 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.
Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5.
FEV1 40 to 90% of predicted.

Who cannot join

Diagnosed with COPD as defined by the GOLD guidelines
Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration

Trial locations and contacts

20 sites in 3 countries.

Country

City, postcode or hospital

20 sites in 3 countries

United States15 sites

Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Aventura, Florida, 33180
Novartis Investigative Site
Boston, Massachusetts, 02115
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Denver, Colorado, 80230
Novartis Investigative Site
Medford, Oregon, 97504-8741
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
Rolling Hills Estates, California, 90274
Novartis Investigative Site
San Marino, California, 91108
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
Winston-Salem, North Carolina, 27157

Other trials in United States

Germany3 sites

Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Wiesbaden, Germany, 65187

Other trials in Germany

United Kingdom2 sites

Novartis Investigative Site
London, United Kingdom, SE11YR
Novartis Investigative Site
Manchester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

Conditions: Asthma
Being tested: QBX258, Placebo
Keywords: Asthma, Interleukin, QBX258, QAX576, VAK694
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QBX258Drug
QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.
PlaceboDrug
The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.

Study groups in NCT01479595
Study group	Role	What they receive
QBX258	Experimental	Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. Receives: Drug: QBX258
Placebo	Placebo comparator	Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Asthma Control Questionnaire (ACQ) Score
The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.
Measured: Baseline and 12 weeks

Secondary outcomes (10)

Change in Forced Expiratory Volume in One Second (FEV1)
FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Measured: Baseline and 12 weeks
Change in Asthma Quality of Life Questionnaire (AQLQ) Score
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.
Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes.
Measured: Baseline and 12 weeks
Morning and Evening Peak Expiratory Flow (PEF) Rate
Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.
Measured: Baseline and 12 weeks
Change From Baseline in Maximum Expiratory Flow
Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Measured: Baseline and 12 weeks
Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies
Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.
Measured: 12 weeks
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte
Blood samples were obtained to measure Cmax,ss.
Measured: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte
Blood samples were obtained to measure Cmax,ss.
Measured: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte
Blood samples were obtained to measure Cmin,ss.
Measured: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte
Blood samples were obtained to measure Cmin,ss.
Measured: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.
Measured: baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Feb 2015

First posted24 Nov 2011 (estimated)
Study startFeb 2012
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01479595
Sponsor's protocol ID: CQBX258X2201
Other IDs: 2011-003066-32
Status last verified: Jun 2016
First submitted: 22 Nov 2011
Last updated: 1 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists
ClinicalTrials.gov ID: NCT01479595
Acronym / sponsor ID: CQBX258X2201
Conditions: Asthma
Keywords: Asthma, Interleukin, QBX258, QAX576, VAK694
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 24 Nov 2011 (estimated)
Results: Posted 1 Aug 2016

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 investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QBX258	Experimental	Drug: QBX258Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.
Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5.
FEV1 40 to 90% of predicted.

Key exclusion criteria (3 listed)

Diagnosed with COPD as defined by the GOLD guidelines
Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration

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
QBX258QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.	Drug	QBX258
PlaceboThe placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.	Drug	Placebo

Primary outcome

Change From Baseline in Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline and 12 weeks
The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.

10 secondary outcomes

Change in Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline and 12 weeks
Change in Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline and 12 weeks
Morning and Evening Peak Expiratory Flow (PEF) Rate
Time frame: Baseline and 12 weeks
Change From Baseline in Maximum Expiratory Flow
Time frame: Baseline and 12 weeks
Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies
Time frame: 12 weeks
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte
Time frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte
Time frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte
Time frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte
Time frame: days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: baseline, 12 weeks

Results and safety

Results posted to the registry on 1 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QBX258	44	42
Placebo	21	19

Primary outcome: Change From Baseline in Asthma Control Questionnaire (ACQ) Score

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	QBX258 n = 41	Placebo n = 19
Value	-0.513 (0.0970)	0.001 (0.1487)

QBX258 vs Placebo: Mean Difference (Net): -0.514 (90% CI -0.811 to -0.217), p = 0.005, Mixed Models Analysis

Population analysed: Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QBX258	1 of 44 (2.3%)	13 of 44 (29.5%)	Not reported
Placebo	1 of 21 (4.8%)	7 of 21 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

Novartis Pharmaceuticals study director

Novartis

20 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QBX258 in people with Asthma, run by Novartis Pharmaceuticals at 20 sites in 3 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 4 inclusion and 3 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, 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?

Yes. Results are posted in the registry (first posted 1 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Asthma Control Questionnaire (ACQ) Score (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479595.

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 1 Aug 2016.