Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01479595
First received: November 22, 2011
Last updated: June 20, 2016
Last verified: June 2016
Results First Received: February 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: QBX258
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were assigned to either QBX258 or placebo in a 2:1 ratio. Randomization was done by stratification of Q576R.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
QBX258 Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
Placebo Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.

Participant Flow:   Overall Study
    QBX258   Placebo
STARTED   44   21 
PK Analysis Set   42   0 
Per Protocol Analysis Set   41   20 
COMPLETED   42   19 
NOT COMPLETED   2   2 
Protocol deviation                0                1 
Adverse Event                2                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
QBX258 Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
Placebo Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
Total Total of all reporting groups

Baseline Measures
   QBX258   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   21   65 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (11.71)   42.8  (13.54)   42.6  (12.22) 
Gender 
[Units: Participants]
     
Female   23   11   34 
Male   21   10   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Asthma Control Questionnaire (ACQ) Score   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Change in Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Change in Asthma Quality of Life Questionnaire (AQLQ) Score   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Morning and Evening Peak Expiratory Flow (PEF) Rate   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Change From Baseline in Maximum Expiratory Flow   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies   [ Time Frame: 12 weeks ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)   [ Time Frame: baseline, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01479595     History of Changes
Other Study ID Numbers: CQBX258X2201
2011-003066-32 ( EudraCT Number )
Study First Received: November 22, 2011
Results First Received: February 23, 2016
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency