Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QBX258 · 1 trial · 1 indication
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...
QBX258 is an investigational small molecule being developed for the treatment of moderate to severe asthma. It is a respiratory therapeutic that has been studied in a Phase 2 clinical trial. The drug is not approved and remains in clinical development.
QBX258 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company sponsored a Phase 2 clinical trial of QBX258 in patients with moderate to severe asthma.
QBX258 is in Phase 2 clinical development. A Phase 2 trial of QBX258 in moderate to severe asthma has been completed. The drug is investigational and has not been approved by regulatory authorities.
QBX258 has been studied in one completed Phase 2 clinical trial, registered as NCT01479595, titled "A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma." The trial enrolled 65 participants in the United States, Germany, and the United Kingdom.
Yes, the Phase 2 clinical trial of QBX258 was a randomized, double-blind, placebo-controlled study. It enrolled 65 adult patients aged 18 years and older with moderate to severe asthma. The trial was conducted at sites in the United States, Germany, and the United Kingdom.