A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain
Summary
This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
Timeline
- Start
- 2023-09-13
- Primary completion
- 2024-08-12
- Completion
- 2024-12-03
Outcome
Missed primary endpoint
Stopped: “The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.”
registry Placebo vs GSK3858279 - 60 mg Weekly; Difference in Posterior Mean Change 0.47 (95% CI -0.23 to 1.17) NCT05838742 ↗
registry Placebo vs GSK3858279 - 240 mg Every 2 Weeks; Difference in Posterior Mean Change 0.25 (95% CI -0.46 to 0.95) NCT05838742 ↗
registry Placebo vs GSK3858279 - 240 mg Weekly; Difference in Posterior Mean Change 0.39 (95% CI -0.31 to 1.10) NCT05838742 ↗
registry Placebo vs GSK3858279 - 360 mg Weekly; Difference in Posterior Mean Change 0.11 (95% CI -0.60 to 0.80) NCT05838742 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DENRAKIBART | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | DENRAKIBART | Monoclonal antibody | 240 mg | Subcutaneous |
| Subject | DENRAKIBART | Monoclonal antibody | 360 mg | Subcutaneous |