Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QBW251 · 2 trials · 2 indications
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.
| Arm | Type | Description |
|---|---|---|
| QBW251 450 mg | EXPERIMENTAL | QBW251 was orally administered 450 mg b.i.d for 24 weeks |
| QBW251 300 mg | EXPERIMENTAL | QBW251 was orally administered 300 mg b.i.d for 24 weeks |
| QBW251 150 mg | EXPERIMENTAL | QBW251 was orally administered 150 mg b.i.d for 24 weeks |
| QBW251 75 mg | EXPERIMENTAL | QBW251 was orally administered 75 mg b.i.d for 24 weeks |
| QBW251 25 mg | EXPERIMENTAL | QBW251 was orally administered 25 mg b.i.d for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo was orally administered b.i.d for 24 weeks |
| QBW251 | EXPERIMENTAL | QBW251 will be provided to participants during 70 days |
| Name | Type | Description |
|---|---|---|
| QBW251 | DRUG | QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks |
| Placebo | DRUG | Placebo oral capsules administered twice a day for 24 weeks |
| COPD maintenance background therapy | DRUG | Combination of fluticasone furoate, vilanterol and umeclidinium bromide |
Inclusion Criteria: * Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. * Current or ex-smokers who have a smoking history of at least 10 pack years. * Patients who have been treated with a triple combination o...
QBW251 is an investigational small molecule being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being developed by Novartis AG (NVS) and has completed Phase 2 clinical trials in patients with COPD.
QBW251 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for Chronic Obstructive Pulmonary Disease.
QBW251 is in Phase 2 clinical development. Two Phase 2 trials have been completed, including a safety, tolerability, and efficacy study and a dose-range finding study, both in patients with Chronic Obstructive Pulmonary Disease. QBW251 is not approved and remains investigational.
QBW251 has completed two Phase 2 clinical trials. The first, NCT02449018, was a safety, tolerability, and efficacy study in 92 COPD patients in the United States and Poland. The second, NCT04072887, was a dose-range finding study in 974 COPD patients across multiple countries.
No alternative names for QBW251 have been reported. The drug is identified solely by its code name QBW251 in clinical trial records and is being developed by Novartis AG for Chronic Obstructive Pulmonary Disease.