drugset / Trial / NCT05838755
A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.
Timeline
- Start
- 2023-09-20
- Primary completion
- 2024-10-14
- Completion
- 2025-02-17
Outcome
Outcome not reported
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.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DENRAKIBART | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | DENRAKIBART | Monoclonal antibody | 360 mg | Subcutaneous |
Indications
No indication recorded.