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Also known as GSK2402968
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 studied for the treatment of muscular dystrophies, specifically Duchenne muscular dystrophy (DMD). It has been evaluated in male patients aged 5 years and older with DMD. The program is in Phase 3 development, and all three completed trials enrolled patients with muscular dystrophies.
GSK2402968 is being developed by GSK plc, which trades under the ticker GSK. The company sponsored all three clinical trials of the compound in Duchenne muscular dystrophy, including two Phase 2 studies and one Phase 3 study.
GSK2402968 has reached Phase 3 development. One Phase 3 trial, NCT01254019, has been completed, along with two completed Phase 2 trials, NCT01462292 and NCT01153932. All three studies are listed as completed, with no active trials currently ongoing.
GSK2402968 has been studied in three completed clinical trials: NCT01254019, a Phase 3 study in Duchenne muscular dystrophy with 186 patients; NCT01462292, a Phase 2 study with 51 patients; and NCT01153932, a Phase 2 double-blind exploratory study with 53 patients. Total enrollment across the program was 290.
The GSK2402968 trials were randomized, double-blind, and controlled, and they used biomarker selection. The Phase 3 study NCT01254019 enrolled 186 patients across 20 countries, while the two Phase 2 studies enrolled 51 and 53 patients. All trials enrolled male patients aged 5 years and older with Duchenne muscular dystrophy.