Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01479595 | A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma | PHASE2 | COMPLETED | 65 | — | — | Feb 1, 2012 | Feb 1, 2015 | Aug 1, 2016 | 20 | United States, Germany +1 |
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.
| Arm | Type | Description |
|---|---|---|
| QBX258 | EXPERIMENTAL | Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total. |
| Name | Type | Description |
|---|---|---|
| QBX258 | DRUG | 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. |
| Placebo | DRUG | The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site. |
Inclusion Criteria: * 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 c...