In short
Clinical trials are studying Gsk3858279 in people with pain from diabetic peripheral neuropathic pain and knee osteoarthritis. These studies are looking at whether it can reduce pain and how safe it is in adults. Both trials are phase 2 studies and have already been completed.
Key points
- Clinical trials of Gsk3858279 are studying pain in two groups: adults with diabetic peripheral neuropathic pain and adults with knee osteoarthritis pain. Both studies are Phase 2 and were completed. The main goal in each trial was to see whether Gsk3858279 could lower pain better than placebo. The trials measured change in weekly average pain intensity at Week 12 using the Numeric Rating Scale. The source data describes these as interventional studies with adult participants.
Clinical trials overview
Two Phase 2 clinical trials studied Gsk3858279 in adults with pain conditions. Both studies were interventional, which means the researchers gave a study treatment and compared it with placebo, a treatment with no active drug.
One trial was NEPTUNE-17, and the other was MARS-17. Both trials are listed as completed.
Diabetic peripheral neuropathic pain study
The NEPTUNE-17 study, NCT05838755, tested Gsk3858279 in people with diabetic peripheral neuropathic pain (DPNP), which is nerve pain linked to diabetes. The study aimed to see whether Gsk3858279 could improve pain compared with placebo.
This study enrolled 240 participants and used a 400 mg subcutaneous injection of Gsk3858279, compared with sterile 0.9% sodium chloride as placebo. The source data does not give more details about the participant rules beyond the condition studied and adult population.
Knee osteoarthritis pain study
The MARS-17 study, NCT05838742, tested Gsk3858279 in adults with knee osteoarthritis pain. Osteoarthritis is a joint disease where the cushioning in the joint wears down, which can cause pain and stiffness.
This dose-finding study enrolled 420 participants and also used a 400 mg subcutaneous injection of Gsk3858279, with sterile 0.9% sodium chloride as placebo. The goal was to see whether Gsk3858279 could reduce knee pain better than placebo.
Study design and main outcomes
Both trials looked at efficacy, which means how well the treatment works, and safety, which means how well it is tolerated in the study setting. The main outcome in each study was the change from baseline in weekly average daily pain intensity at Week 12.
Pain was measured with the Numeric Rating Scale (NRS), a number-based pain score used in clinical research. “Baseline” means the starting pain level before treatment, so the studies compared pain after treatment with the starting point.
Who participated
The trials focused on adults with either diabetic peripheral neuropathic pain or knee osteoarthritis pain. The source data does not list extra details such as age limits, previous treatments, or other entry rules.
- DPNP trial: adults with diabetic nerve pain in the NEPTUNE-17 study.
- Knee osteoarthritis trial: adults with knee pain from osteoarthritis in the MARS-17 study.
- Shared design: both studies compared Gsk3858279 with placebo and measured pain at Week 12.