Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2402968/kg/week · 3 trials · 1 indication
During the 6MWD, participants were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told that they may stop earlier if they feel unable to continue. The total distance walked within 6 minutes (or until the participant stopped in case of early termination of the test), the 6MWD, was recorded in meters as well as any falls. Baseline was defined as participants randomization assessment at Visit 3 (Day 0). Change from Baseline was calculated by subtracting the Baseline value from the value at Week 48.
The participants during this assessment were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in meters. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.
| Arm | Type | Description |
|---|---|---|
| GSK2402968 | EXPERIMENTAL | 6mg/kg |
| Placebo | EXPERIMENTAL | dose-matched |
| GSK2402968 3 mg/kg/week | EXPERIMENTAL | 3 mg/kg/week of investigational product |
| GSK2402968 6 mg/kg/week | EXPERIMENTAL | 6 mg/kg/week of investigational Product |
| Placebo to match GSK2402968 3 mg/kg/week | EXPERIMENTAL | Placebo |
| Placebo to match GSK2402968 6 mg/kg/week | EXPERIMENTAL | Placebo |
| Continuous regimen; 6mg/kg once weekly | EXPERIMENTAL | Once Weekly |
| Intermittent regimen; 6mg/kg twice weekly | EXPERIMENTAL | Twice weekly on 1st, 3rd and 5th weeks, once weekly on 2nd, 4th and 6th weeks, and no active drug on 7th to 10th week of each 10 week cycle |
| Name | Type | Description |
|---|---|---|
| GSK2402968 6mg/kg/week | DRUG | subcutaneous |
| GSK2402968 3mg/kg/week | DRUG | Comparison of 2 doses of GSK2402968 |
| GSK2402968 6 mg/kg/week | DRUG | Comparison of 2 doses of GSK2402968 |
| Placebo to match GSK2402968 3 mg/kg/week | DRUG | Matched placebo |
| Placebo to match GSK2402968 6 mg/kg/week | DRUG | Matched Placebo |
| GSK2402968 | DRUG | Subcutaneous injection |
| matched placebo | DRUG | Subcutaneous injection |
Inclusion Criteria: * Ambulant subjects with Duchenne muscular dystrophy resulting from a mutation/deletion within the DMD gene, confirmed by a state-of-the-art DNA diagnostic technique covering all DMD gene exons, including but not limited to MLPA (Multiplex Ligation-dependent Probe Amplification)...
GSK2402968 is an investigational small molecule being developed for the treatment of muscular dystrophies, specifically Duchenne muscular dystrophy (DMD). It has been studied in clinical trials enrolling male subjects aged 5 years and older with this condition. The drug is not approved and remains in clinical development.
GSK2402968 is being developed by GSK plc, a global biopharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company has sponsored clinical trials of this investigational drug in multiple countries across Europe, the Americas, Asia, and the Middle East.
GSK2402968 has completed Phase 2 and Phase 3 clinical trials. The most advanced study was a Phase 3 trial (NCT01254019) that has been completed. However, the drug is still considered investigational and has not been approved by regulatory authorities. No active trials are currently listed.
GSK2402968 has been studied in three completed clinical trials. NCT01153932 was a Phase 2 double-blind exploratory study in 53 ambulant subjects. NCT01254019 was a Phase 3 efficacy and safety study in 186 subjects. NCT01462292 was a Phase 2 dose-comparison study in 51 subjects in the United States.
GSK2402968 is a distinct investigational small molecule developed specifically for Duchenne muscular dystrophy. It is not known to be the same as any other approved or investigational drug. Its mechanism of action has not been disclosed in the available clinical trial information.