Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK679586 · 2 trials · 1 indication
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
| Arm | Type | Description |
|---|---|---|
| GSK679586 | EXPERIMENTAL | Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization |
| PLACEBO | PLACEBO_COMPARATOR | Subjects will receive three, once monthly intravenous administration of saline, according to randomization |
| Active | ACTIVE_COMPARATOR | GSK679586 |
| Name | Type | Description |
|---|---|---|
| INTRAVENOUS GSK679586 | DRUG | GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump |
| INTRAVENOUS PLACEBO | DRUG | Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump |
| FLUTICASONE PROPIONATE | DRUG | Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose. |
| GSK679586 | DRUG | Active Drug |
| Placebo | DRUG | Saline |
Inclusion Criteria: * history of asthma for ≥ 6 months * taking inhaled corticosteroids * non-smoking * Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening. * Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol. * sy...
GSK679586 is an investigational small molecule being developed for the treatment of asthma. It has been studied in patients with severe asthma as well as in healthy and mild asthmatic volunteers. The drug is currently in Phase 2 clinical development and is not approved by regulatory authorities.
GSK679586 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK. The company has conducted clinical trials of GSK679586 in multiple countries including the United States, France, Germany, Netherlands, Norway, Poland, South Africa, United Kingdom, and Australia.
GSK679586 is in Phase 2 clinical development for asthma. The drug has completed two clinical trials, including a Phase 1 study in healthy and mild asthmatic volunteers and a Phase 2 efficacy and safety study in patients with severe asthma. GSK679586 remains investigational and has not received FDA approval.
GSK679586 has been studied in two completed clinical trials. NCT00411814 was a Phase 1 study of GSK679586A infused into healthy and mild asthmatic volunteers in Australia, enrolling 56 participants. NCT00843193 was a Phase 2 efficacy and safety study in 198 patients with severe asthma across eight countries.
GSK679586 is also known as GSK679586A, as referenced in the clinical trial title for NCT00411814. Both names refer to the same investigational drug being developed by GSK plc for asthma. The drug has been evaluated in both Phase 1 and Phase 2 clinical trials.